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NCT Number: NCT06418633

Variations in the Hemostatic System Induced by a Standardized Walking Test

Two groups of patients will be compared: One group of patients with a history of venous thromboembolic disease and one group without. Both groups will be subjected to a walking test and with electrocardiogram measurements and blood tests.

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Key information

Conditions

Venous Thromboembolism Behavior Cardiovascular Diseases Embolism and Thrombosis Motor Activity Thromboembolism Vascular Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

Induced venous thromboembolism is a situation in which venous thromboembolic disease is triggered by an acute event that activates hemostasis: surgery, trauma, infectious or inflammatory outbreak, etc., a situation in which the risk of spontaneous recurrence, in the absence of a new provoking circumstance, is low, leading to the suggestion, not of long-term thromboprophylaxis, but simply the transient prevention of an event when there is a new clinical event likely to activate hemostasis. One such event is acute physical exertion.

Indeed, cohort studies seem to show that regular physical activity is associated with a low incidence of venous thromboembolism. Trained individuals have an endogenous thrombotic potential, assessed by the thrombin TGT test, lower than that of sedentary controls. A 3-month regimen of daily endurance exercise reduces thrombin generation controls and optimizes the fibrinolytic system. Repetitive exercise is accompanied by a depletion of exercise-induced platelet activation. However, several cases of venous thromboembolism have been reported in high-level athletes without usual risk factors and acute high-intensity rowing induces an acute increase in thrombin generation immediately after exercise, which disappears within 16 to 24 hours. The relationship between the level of physical activity and the risk of VTE could be a U-shaped relation, with an increasing risk of event in intense acute practice.

However, no data exists on the hemostatic impact of an acute session of physical activity in patients with a history of venous thromboembolism. Thus, the hypothesis is that exercise-induced response of hemostasis differ in patients with an history of provoked VTE compared to subjects without a history of venous thromboembolism.

This is a proof-of-concept, pathophysiological, single-center, cross-sectional, prospective comparison study of a group of patients with a personal history of induced Venous thromboembolism to a group of sex- and age- and sex-matched controls (+/- 5 years).

  • Type of clinical study: Stress test-induced variations in parameters describing the results of the thrombin generation test (Thromboscreen®) in a group of Patients (Cases) will be compared with those obtained in a group of Control subjects (Controls) with a ratio 1:1.

The Patients group comprises 47 patients with a personal history of induced venous thromboembolism, the last event dating back to more than 6 months, whose clinical phenotype did not justify long-term antithrombotic drug prophylaxis.The Control group comprises 47 patients with no personal history of venous thromboembolism and no family history of venous thromboembolism in first-degree relatives.

The study intervention consists of an hour-long walking test and two blood tests in both groups for all participants (Controls and Patients).

  • Intra-individual reproducibility will be analyzed in 20 subjects (10 patients and 10 controls) who will take the walking test twice on two separate days.

Patients will be selected during a venous thromboembolism follow-up consultation by a physician from either department (Vascular Medicine Consultation or Biological Hematology and Consultations).Inclusion and non-inclusion criteria will be checked, and the study will be explained to participants (patients and controls).Patients and controls will be systematically asked to take part in the variability analysis on a voluntary basis, until 10 subjects per group have agreed to carry out the second test.

The walking test is performed in the morning, 2 hours after a standard breakfast, on a treadmill. It will be preceded by a clinical examination, a resting 12-lead electrocardiogram and a brachial pressure measurement. After a 3-minute warm-up and "habituation" period (walking speed 2.5 km per hour with no incline), the speed and incline will be gradually increased until a target heart rate close to the theoretical ventilatory threshold, and of the order of 70% of the theoretical maximum value (evaluated by Astrand's formula: 220-age), so as to maintain aerobic exercise conditions of moderate intensity, enabling prolonged effort to be maintained. Blood samples will be taken from each participant whilst at rest, before undergoing the 60-minute walking test, in a sitting position, and just after the exercise test.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Inclusion criteria common to both groups :
  • Patients who have given written informed consent.
  • Patients who are affiliated to or beneficiaries of a social security scheme.

Inclusion criteria

specific to the Patient Group:

  • Patients with a personal history of provoked venous thromboembolism, venous thrombosis and/or pulmonary embolism, with the last attack dating back to more than 6 months, and whose clinical phenotype did not justify long-term antithrombotic drug prophylaxis.

Definition of provoked venous thromboembolism : The clinical criteria used to classify venous thromboembolism as provoked are :

  • First year of combined oestrogen-progestogen oral contraception, or contraception using an oestrogen-impregnated vaginal ring or transcutaneous synthetic oestrogen patch.
  • Hormonal stimulation for oocyte retrieval
  • Pregnancy and 6 weeks post-partum
  • Surgery
  • Trauma
  • Immobilisation in plaster or splint
  • Outbreak of acute infectious disease
  • Acute flare-up of inflammatory disease
  • Prolonged air travel lasting at least 4 hours
  • Prolonged strict bed rest lasting at least 3 consecutive days.

Inclusion criteria

specific to the Control Group:

  • Subjects with no personal history of venous thromboembolism
  • Subjects with no family history of venous thromboembolism in first-degree relatives
  • Subjects of the same sex and age with a tolerance of +/- 5 years in relation to the matched case.

Exclusion criteria

  • Patients who are physically unable to perform the 60-minute walking test, for any reason, in particular cardiovascular contraindications to exercise (recent acute coronary syndrome unstable angina, rhythm disorders, tight aortic stenosis, cardiac heart failure, acute myocarditis, pericarditis or endocarditis endocarditis, poorly controlled hypertension, pre-stress blood pressure > 200/110 mmHg, recent stroke or transient ischemic attack).
  • Patients on anticoagulant or antithrombotic treatment, ongoing or discontinued within the last month.
  • Patients treated for pulmonary embolism who remain dyspneic after anticoagulant treatment and requiring a work-up for pulmonary hypertension.
  • Last surgery dating back to less than 3 months.
  • Known chronic morbidities: diabetes mellitus, chronic inflammatory or infectious disease, heart failure, renal insufficiency, hepatic insufficiency or arterial thrombosis dating back to less than 3 months.
  • For women: treatment containing synthetic or natural estrogen, in progress or discontinued for less than a month
  • Pregnancy within the last year.
  • Difficult venous access.
  • Regular practice of an intensive sporting/physical activity, such as running, tennis, cycling etc. of more than 3 hours per week.

Treatment and study plan

60-minute walking test

Other

Treadmill walking test in the morning, 2 hours after breakfast, following a clinical examination, resting 12-lead electrocardiogram and blood pressure measurement. After a 3-minute warm-up and walking of speed 2.5 km per hour, no incline, the speed and incline are gradually increased to reach a target heart rate close to the theoretical ventilatory threshold, around 70% of the theoretical maximum value (evaluated by Astrand's formula: 220-age), i.e. aerobic conditions of moderate intensity so that prolonged effort can be maintained. Test performed in presence of a physician trained in stress testing. Emergency cart and defibrillator available in the department. Intra-hospital vital emergency protocol in place, with resuscitation teams on standby. The cardiology department, in the same building, can be contacted in the event of a cardiological abnormality during the test or recovery. The test takes 60 minutes, including a 3-minute initial warm-up.

Static blood test

Diagnostic Test

33.3 ml of blood will be taken from each participant whilst at rest, before undergoing the 60-minute walking test

Post-effort blood test

Diagnostic Test

33.3 ml of blood will be taken from each participant immediately after undergoing the 60-minute walking test.

Electrocardiogram

Other

An electrocardiogram will be carried out throughout the exercise period and during the first 30 minutes of recovery.

Blood pressure monitoring

Other

Blood pressure will be monitored out throughout the exercise period and during the first 30 minutes of recovery.

Primary outcomes

  1. Thrombin generation dosage before effort in controls

    Time frame: Day 0

    The amount of thrombomodulin in the blood will be measured in nmol/L with the help of Thromboscreen(TM)

  2. Thrombin generation dosage before effort in patients

    Time frame: Day 0

    The amount of thrombomodulin in the blood will be measured in nmol/L with the help of Thromboscreen(TM)

  3. Thrombin generation dosage after effort in controls

    Time frame: Day 0

    The amount of thrombomodulin in the blood will be measured in nmol/L with the help of Thromboscreen(TM). The difference between measurements before and after effort will be measured in nM.min-1

  4. Thrombin generation dosage after effort in patients

    Time frame: Day 0

    The amount of thrombomodulin in the blood will be measured in nmol/L with the help of Thromboscreen(TM). The difference between measurements before and after effort will be measured in nM.min-1

  5. Thrombin generation dosage before effort in the "Individual reproducibility" subgroup: controls

    Time frame: Day 7

    The amount of thrombomodulin in the blood will be measured in nmol/L with the help of Thromboscreen(TM)

  6. Thrombin generation dosage before effort in the "Individual reproducibility" subgroup: patients

    Time frame: Day 7

    The amount of thrombomodulin in the blood will be measured in nmol/L with the help of Thromboscreen(TM)

  7. Thrombin generation dosage after effort in the "Individual reproducibility" subgroup: controls

    Time frame: Day 7

    The amount of thrombomodulin in the blood will be measured in nmol/L with the help of Thromboscreen(TM). The difference between measurements before and after effort will be measured in nM.min-1

  8. Thrombin generation dosage after effort in the "Individual reproducibility" subgroup: patients

    Time frame: Day 7

    The amount of thrombomodulin in the blood will be measured in nmol/L with the help of Thromboscreen(TM). The difference between measurements before and after effort will be measured in nM.min-1

Secondary outcomes

  1. Distribution in the Control group

    Time frame: Day 0

    Measurements in nM.min-1 will be compared to elicit central tendency, dispersion and heterogeneity in the Control group

  2. Distribution in the Patient group

    Time frame: Day 0

    Measurements in nM.min-1 will be compared to elicit central tendency, dispersion and heterogeneity in the Patient group

  3. Thromboscreen test in Controls in the absence of thrombomodulin : Latency time

    Time frame: Day 0

    Latency time in the absence of thrombomodulin will be measured in seconds in Controls.

  4. Thromboscreen test in Controls in the absence of thrombomodulin : Thrombin peak intensity

    Time frame: Day 0

    Thrombin peak intensity in the absence of thrombomodulin will be measured in Controls.

  5. Thromboscreen test in Controls in the absence of thrombomodulin : Time-to-peak thrombin

    Time frame: Day 0

    Time-to-peak thrombin in the absence of thrombomodulin will be measured in Controls.

  6. Thromboscreen test in Controls in the absence of thrombomodulin : Initial thrombin generation velocity

    Time frame: Day 0

    Initial thrombin generation velocity in the absence of thrombomodulin will be measured in seconds in Controls.

  7. Thromboscreen test in Controls in the absence of thrombomodulin : Time to return to baseline

    Time frame: Day 0

    Time to return to baseline in the absence of thrombomodulin will be measured in seconds in Controls.

  8. Thromboscreen test in Controls in the presence of thrombomodulin : Latency time

    Time frame: Day 0

    Latency time in the presence of thrombomodulin will be measured in seconds in Controls.

  9. Thromboscreen test in Controls in the presence of thrombomodulin : Thrombin peak intensity

    Time frame: Day 0

    Thrombin peak intensity in the presence of thrombomodulin will be measured in Controls.

  10. Thromboscreen test in Controls in the presence of thrombomodulin : Time-to-peak thrombin

    Time frame: Day 0

    Time-to-peak thrombin in the presence of thrombomodulin will be measured in Controls.

  11. Thromboscreen test in Controls in the presence of thrombomodulin : Initial thrombin generation velocity

    Time frame: Day 0

    Initial thrombin generation velocity in the presence of thrombomodulin will be measured in seconds in Controls.

  12. Thromboscreen test in Controls in the presence of thrombomodulin : Time to return to baseline

    Time frame: Day 0

    Time to return to baseline in the presence of thrombomodulin will be measured in seconds in Controls.

  13. Thromboscreen test in Patients in the absence of thrombomodulin : Latency time

    Time frame: Day 0

    Latency time in the absence of thrombomodulin will be measured in seconds in Patients.

  14. Thromboscreen test in Patients in the absence of thrombomodulin : Thrombin peak intensity

    Time frame: Day 0

    Thrombin peak intensity in the absence of thrombomodulin will be measured in Patients.

  15. Thromboscreen test in Patients in the absence of thrombomodulin : Time-to-peak thrombin

    Time frame: Day 0

    Time-to-peak thrombin, initial thrombin generation velocity, time to return to baseline for the thrombin generation test performed in the absence of thrombomodulin will be measured in seconds in Patients.

  16. Thromboscreen test in Patients in the absence of thrombomodulin : Initial thrombin generation velocity

    Time frame: Day 0

    Initial thrombin generation velocity in the absence of thrombomodulin will be measured in seconds in Patients.

  17. Thromboscreen test in Patients in the absence of thrombomodulin : Time to return to baseline

    Time frame: Day 0

    Time to return to baseline in the absence of thrombomodulin will be measured in seconds in Patients.

  18. Thromboscreen test in Patients in the presence of thrombomodulin : Latency time

    Time frame: Day 0

    Latency time in the presence of thrombomodulin will be measured in seconds in Patients.

  19. Thromboscreen test in Patients in the presence of thrombomodulin : Thrombin peak intensity

    Time frame: Day 0

    Thrombin peak intensity in the presence of thrombomodulin will be measured in seconds in Patients.

  20. Thromboscreen test in Patients in the presence of thrombomodulin : Time-to-peak thrombin

    Time frame: Day 0

    Time-to-peak thrombin in the presence of thrombomodulin be measured in seconds in Patients.

  21. Thromboscreen test in Patients in the presence of thrombomodulin : Initial thrombin generation velocity

    Time frame: Day 0

    Initial thrombin generation velocity in the presence of thrombomodulin will be measured in seconds in Patients.

  22. Thromboscreen test in Patients in the presence of thrombomodulin : Time to return to baseline

    Time frame: Day 0

    Time to return to baseline in the presence of thrombomodulin will be measured in seconds in Patients.

  23. Distribution of other parameters of the Thromboscreen test in Controls

    Time frame: Day 0

    The distribution (central tendency, dispersion, heterogeneity), of the various biological parameters (latency time, thrombin peak intensity, time-to-peak thrombin, initial thrombin generation velocity, time to return to baseline) will be measured in Controls

  24. Distribution of other parameters of the Thromboscreen test in Patients

    Time frame: Day 0

    The distribution (central tendency, dispersion, heterogeneity), of the various biological parameters (latency time, thrombin peak intensity, time-to-peak thrombin, initial thrombin generation velocity, time to return to baseline) will be measured in Patients

  25. Endogenous Thrombotic Potential in the presence of thrombomodulin in Controls

    Time frame: Day 0

    nM.min

  26. Endogenous Thrombotic Potential in the absence of thrombomodulin in Controls

    Time frame: Day 0

    nM.min

  27. Endogenous Thrombotic Potential in the presence of thrombomodulin in Patients

    Time frame: Day 0

    nM.min

  28. Endogenous Thrombotic Potential in the absence of thrombomodulin in Patients

    Time frame: Day 0

    nM.min

  29. Heterogeneity of Endogenous Thrombotic Potential in Controls

    Time frame: Day 0

    Statistical analysis, Cochrane's Q test

  30. Heterogeneity of Endogenous Thrombotic Potential in Patients

    Time frame: Day 0

    Statistical analysis, Cochrane's Q test

  31. Complete Blood Count in Controls before the walking test: White blood cells

    Time frame: Day 0

    White blood cells will be measured in thousands/µL

  32. Complete Blood Count in Controls before the walking test: White blood cells

    Time frame: Day 7

    White blood cells will be measured in thousands/µL

  33. Complete Blood Count in Controls after the walking test: White blood cells

    Time frame: Day 0

    White blood cells will be measured in thousands/µL

  34. Complete Blood Count in Controls after the walking test: White blood cells

    Time frame: Day 7

    White blood cells will be measured in thousands/µL

  35. Complete Blood Count in Patients before the walking test: White blood cells

    Time frame: Day 0

    White blood cells will be measured in thousands/µL

  36. Complete Blood Count in Patients before the walking test: White blood cells

    Time frame: Day 7

    White blood cells will be measured in thousands/µL

  37. Complete Blood Count in Patients after the walking test: White blood cells

    Time frame: Day 0

    White blood cells will be measured in thousands/µL

  38. Complete Blood Count in Patients after the walking test: White blood cells

    Time frame: Day 7

    White blood cells will be measured in thousands/µL

  39. Complete Blood Count in Controls before the walking test: Red blood cells

    Time frame: Day 0

    Red blood cells will be measured in millions per cubic millimeter

  40. Complete Blood Count in Controls before the walking test: Red blood cells

    Time frame: Day 7

    Red blood cells will be measured in millions per cubic millimeter

  41. Complete Blood Count in Patients before the walking test: Red blood cells

    Time frame: Day 0

    Red blood cells will be measured in millions per cubic millimeter

  42. Complete Blood Count in Patients before the walking test: Red blood cells

    Time frame: Day 7

    Red blood cells will be measured in millions per cubic millimeter

  43. Complete Blood Count in Controls after the walking test: Red blood cells

    Time frame: Day 0

    Red blood cells will be measured in millions per cubic millimeter

  44. Complete Blood Count in Controls after the walking test: Red blood cells

    Time frame: Day 7

    Red blood cells will be measured in millions per cubic millimeter

  45. Complete Blood Count in Patients after the walking test: Red blood cells

    Time frame: Day 0

    Red blood cells will be measured in millions per cubic millimeter

  46. Complete Blood Count in Patients after the walking test: Red blood cells

    Time frame: Day 7

    Red blood cells will be measured in millions per cubic millimeter

  47. Complete Blood Count in Controls before the walking test:Hemaglobin

    Time frame: Day 0

    Hemaglobin will be measured in g/L

  48. Complete Blood Count in Controls before the walking test:Hemaglobin

    Time frame: Day 7

    Hemaglobin will be measured in g/L

  49. Complete Blood Count in Patients before the walking test:Hemaglobin

    Time frame: Day 0

    Hemaglobin will be measured in g/L

  50. Complete Blood Count in Patients before the walking test:Hemaglobin

    Time frame: Day 7

    Hemaglobin will be measured in g/L

  51. Complete Blood Count in Controls after the walking test: Hemaglobin

    Time frame: Day 0

    Hemaglobin will be measured in g/L

  52. Complete Blood Count in Controls after the walking test: Hemaglobin

    Time frame: Day 7

    Hemaglobin will be measured in g/L

  53. Complete Blood Count in Patients after the walking test: Hemaglobin

    Time frame: Day 0

    Hemaglobin will be measured in g/L

  54. Complete Blood Count in Patients after the walking test: Hemaglobin

    Time frame: Day 7

    Hemaglobin will be measured in g/L

  55. Complete Blood Count in Controls before the walking test: Hematocrite

    Time frame: Day 0

    Hematrocrite will be measured in L/L

  56. Complete Blood Count in Controls before the walking test: Hematocrite

    Time frame: Day 7

    Hematrocrite will be measured in L/L

  57. Complete Blood Count in Patients before the walking test: Hematocrite

    Time frame: Day 0

    Hematrocrite will be measured in L/L

  58. Complete Blood Count in Patients before the walking test: Hematocrite

    Time frame: Day 7

    Hematrocrite will be measured in L/L

  59. Complete Blood Count in Controls after the walking test: Hematocrite

    Time frame: Day 0

    Hematrocrite will be measured in L/L

  60. Complete Blood Count in Controls after the walking test: Hematocrite

    Time frame: Day 7

    Hematrocrite will be measured in L/L

  61. Complete Blood Count in Patients after the walking test: Hematocrite

    Time frame: Day 0

    Hematrocrite will be measured in L/L

  62. Complete Blood Count in Patients after the walking test: Hematocrite

    Time frame: Day 7

    Hematrocrite will be measured in L/L

  63. Complete Blood Count in Controls before the walking test: mean corpuscular volume

    Time frame: Day 0

    Mean corpuscular volume will be measured in fL

  64. Complete Blood Count in Controls before the walking test: mean corpuscular volume

    Time frame: Day 7

    Mean corpuscular volume will be measured in fL

  65. Complete Blood Count in Patients before the walking test: mean corpuscular volume

    Time frame: Day 0

    Mean corpuscular volume will be measured in fL

  66. Complete Blood Count in Patients before the walking test: mean corpuscular volume

    Time frame: Day 7

    Mean corpuscular volume will be measured in fL

  67. Complete Blood Count in Controls after the walking test: mean corpuscular volume

    Time frame: Day 0

    Mean corpuscular volume will be measured in fL

  68. Complete Blood Count in Controls after the walking test: mean corpuscular volume

    Time frame: Day 7

    Mean corpuscular volume will be measured in fL

  69. Complete Blood Count in Patients after the walking test: mean corpuscular volume

    Time frame: Day 0

    Mean corpuscular volume will be measured in fL

  70. Complete Blood Count in Patients after the walking test: mean corpuscular volume

    Time frame: Day 7

    Mean corpuscular volume will be measured in fL

  71. Complete Blood Count in Controls before the walking test: mean corpuscular hemoglobin

    Time frame: Day 0

    Mean Corpuscular Hemoglobin will be measured in pg

  72. Complete Blood Count in Controls before the walking test: mean corpuscular hemoglobin

    Time frame: Day 7

    Mean Corpuscular Hemoglobin will be measured in pg

  73. Complete Blood Count in Patients before the walking test: mean corpuscular hemoglobin

    Time frame: Day 0

    Mean Corpuscular Hemoglobin will be measured in pg

  74. Complete Blood Count in Patients before the walking test: mean corpuscular hemoglobin

    Time frame: Day 7

    Mean Corpuscular Hemoglobin will be measured in pg

  75. Complete Blood Count in Controls after the walking test: Mean corpuscular hemoglobin

    Time frame: Day 0

    Mean Corpuscular Hemoglobin will be measured in pg

  76. Complete Blood Count in Controls after the walking test: Mean corpuscular hemoglobin

    Time frame: Day 7

    Mean Corpuscular Hemoglobin will be measured in pg

  77. Complete Blood Count in Patients after the walking test: Mean corpuscular hemoglobin

    Time frame: Day 0

    Mean Corpuscular Hemoglobin will be measured in pg

  78. Complete Blood Count in Patients after the walking test: Mean corpuscular hemoglobin

    Time frame: Day 7

    Mean Corpuscular Hemoglobin will be measured in pg

  79. Complete Blood Count in Controls before the walking test: Mean corpuscular hemoglobin concentration

    Time frame: Day 0

    Mean Corpuscular Hemoglobin Concentration will be measured in g/L

  80. Complete Blood Count in Controls before the walking test: Mean corpuscular hemoglobin concentration

    Time frame: Day 7

    Mean Corpuscular Hemoglobin Concentration will be measured in g/L

  81. Complete Blood Count in Patients before the walking test: Mean corpuscular hemoglobin concentration

    Time frame: Day 0

    Mean Corpuscular Hemoglobin Concentration will be measured in g/L

  82. Complete Blood Count in Patients before the walking test: Mean corpuscular hemoglobin concentration

    Time frame: Day 7

    Mean Corpuscular Hemoglobin Concentration will be measured in g/L

  83. Complete Blood Count in Controls after the walking test: Mean corpuscular hemoglobin concentration

    Time frame: Day 0

    Mean Corpuscular Hemoglobin Concentration will be measured in g/L

  84. Complete Blood Count in Controls after the walking test: Mean corpuscular hemoglobin concentration

    Time frame: Day 7

    Mean Corpuscular Hemoglobin Concentration will be measured in g/L

  85. Complete Blood Count in Patients after the walking test: Mean corpuscular hemoglobin concentration

    Time frame: Day 0

    Mean Corpuscular Hemoglobin Concentration will be measured in g/L

  86. Complete Blood Count in Patients after the walking test: Mean corpuscular hemoglobin concentration

    Time frame: Day 7

    Mean Corpuscular Hemoglobin Concentration will be measured in g/L

  87. Complete Blood Count in Controls before the walking test: red cell distribution width

    Time frame: Day 0

    Red cell distribution width will be measured as %

  88. Complete Blood Count in Controls before the walking test: red cell distribution width

    Time frame: Day 7

    Red cell distribution width will be measured as %

  89. Complete Blood Count in Patients before the walking test: red cell distribution width

    Time frame: Day 0

    Red cell distribution width will be measured as %

  90. Complete Blood Count in Patients before the walking test: red cell distribution width

    Time frame: Day 7

    Red cell distribution width will be measured as %

  91. Complete Blood Count in Controls after the walking test: red cell distribution width

    Time frame: Day 0

    Red cell distribution width will be measured as %

  92. Complete Blood Count in Controls after the walking test: red cell distribution width

    Time frame: Day 7

    Red cell distribution width will be measured as %

  93. Complete Blood Count in Patients after the walking test: red cell distribution width

    Time frame: Day 0

    Red cell distribution width will be measured as %

  94. Complete Blood Count in Patients after the walking test: red cell distribution width

    Time frame: Day 7

    Red cell distribution width will be measured as %

  95. Complete Blood Count in Controls before the walking test: Platelets

    Time frame: Day 0

    Platelets will be measured in thousands/µL

  96. Complete Blood Count in Controls before the walking test: Platelets

    Time frame: Day 7

    Platelets will be measured in thousands/µL

  97. Complete Blood Count in Patients before the walking test: Platelets

    Time frame: Day 0

    Platelets will be measured in thousands/µL

  98. Complete Blood Count in Patients before the walking test: Platelets

    Time frame: Day 7

    Platelets will be measured in thousands/µL

  99. Complete Blood Count in Controls after the walking test: Platelets

    Time frame: Day 0

    Platelets will be measured in thousands/µL

  100. Complete Blood Count in Controls after the walking test: Platelets

    Time frame: Day 7

    Platelets will be measured in thousands/µL

  101. Complete Blood Count in Patients after the walking test: Platelets

    Time frame: Day 0

    Platelets will be measured in thousands/µL

  102. Complete Blood Count in Patients after the walking test: Platelets

    Time frame: Day 7

    Platelets will be measured in thousands/µL

  103. Complete Blood Count in Controls before the walking test: Neutrophils

    Time frame: Day 0

    Neutrophils will be measured in thousands/µL

  104. Complete Blood Count in Controls before the walking test: Neutrophils

    Time frame: Day 7

    Neutrophils will be measured in thousands/µL

  105. Complete Blood Count in Patients before the walking test: Neutrophils

    Time frame: Day 0

    Neutrophils will be measured in thousands/µL

  106. Complete Blood Count in Patients before the walking test: Neutrophils

    Time frame: Day 7

    Neutrophils will be measured in thousands/µL

  107. Complete Blood Count in Controls after the walking test: Neutrophils

    Time frame: Day 0

    Neutrophils will be measured in thousands/µL

  108. Complete Blood Count in Controls after the walking test: Neutrophils

    Time frame: Day 7

    Neutrophils will be measured in thousands/µL

  109. Complete Blood Count in Patients after the walking test: Neutrophils

    Time frame: Day 0

    Neutrophils will be measured in thousands/µL

  110. Complete Blood Count in Patients after the walking test: Neutrophils

    Time frame: Day 7

    Neutrophils will be measured in thousands/µL

  111. Complete Blood Count in Controls before the walking test: Lymphocytes

    Time frame: Day 0

    Lymphocytes will be measured in thousands/µL

  112. Complete Blood Count in Controls before the walking test: Lymphocytes

    Time frame: Day 7

    Lymphocytes will be measured in thousands/µL

  113. Complete Blood Count in Patients before the walking test: Lymphocytes

    Time frame: Day 0

    Lymphocytes will be measured in thousands/µL

  114. Complete Blood Count in Patients before the walking test: Lymphocytes

    Time frame: Day 7

    Lymphocytes will be measured in thousands/µL

  115. Complete Blood Count in Controls after the walking test: Lymphocytes

    Time frame: Day 0

    Lymphocytes will be measured in thousands/µL

  116. Complete Blood Count in Controls after the walking test: Lymphocytes

    Time frame: Day 7

    Lymphocytes will be measured in thousands/µL

  117. Complete Blood Count in Patients after the walking test: Lymphocytes

    Time frame: Day 0

    Lymphocytes will be measured in thousands/µL

  118. Complete Blood Count in Patients after the walking test: Lymphocytes

    Time frame: Day 7

    Lymphocytes will be measured in thousands/µL

  119. Complete Blood Count in Controls before the walking test: Monocytes

    Time frame: Day 0

    Monocytes will be measured in thousands/µL

  120. Complete Blood Count in Controls before the walking test: Monocytes

    Time frame: Day 7

    Monocytes will be measured in thousands/µL

  121. Complete Blood Count in Patients before the walking test: Monocytes

    Time frame: Day 0

    Monocytes will be measured in thousands/µL

  122. Complete Blood Count in Patients before the walking test: Monocytes

    Time frame: Day 7

    Monocytes will be measured in thousands/µL

  123. Complete Blood Count in Controls after the walking test: Monocytes

    Time frame: Day 0

    Monocytes will be measured in thousands/µL

  124. Complete Blood Count in Controls after the walking test: Monocytes

    Time frame: Day 7

    Monocytes will be measured in thousands/µL

  125. Complete Blood Count in Patients after the walking test: Monocytes

    Time frame: Day 0

    Monocytes will be measured in thousands/µL

  126. Complete Blood Count in Patients after the walking test: Monocytes

    Time frame: Day 7

    Monocytes will be measured in thousands/µL

  127. Complete Blood Count in Controls before the walking test: Eosinophils

    Time frame: Day 0

    Eosinophils will be measured in hundreds/µL

  128. Complete Blood Count in Controls before the walking test: Eosinophils

    Time frame: Day 7

    Eosinophils will be measured in hundreds/µL

  129. Complete Blood Count in Patients before the walking test: Eosinophils

    Time frame: Day 0

    Eosinophils will be measured in hundreds/µL

  130. Complete Blood Count in Patients before the walking test: Eosinophils

    Time frame: Day 7

    Eosinophils will be measured in hundreds/µL

  131. Complete Blood Count in Controls after the walking test: Eosinophils

    Time frame: Day 0

    Eosinophils will be measured in hundreds/µL

  132. Complete Blood Count in Controls after the walking test: Eosinophils

    Time frame: Day 7

    Eosinophils will be measured in hundreds/µL

  133. Complete Blood Count in Patients after the walking test: Eosinophils

    Time frame: Day 0

    Eosinophils will be measured in hundreds/µL

  134. Complete Blood Count in Patients after the walking test: Eosinophils

    Time frame: Day 7

    Eosinophils will be measured in hundreds/µL

  135. Complete Blood Count in Controls before the walking test: Basophils

    Time frame: Day 0

    Basophils will be measured in thousands/µL

  136. Complete Blood Count in Controls before the walking test: Basophils

    Time frame: Day 7

    Basophils will be measured in thousands/µL

  137. Complete Blood Count in Patients before the walking test: Basophils

    Time frame: Day 0

    Basophils will be measured in thousands/µL

  138. Complete Blood Count in Patients before the walking test: Basophils

    Time frame: Day 7

    Basophils will be measured in thousands/µL

  139. Complete Blood Count in Controls after the walking test: Basophils

    Time frame: Day 0

    Basophils will be measured in thousands/µL

  140. Complete Blood Count in Controls after the walking test: Basophils

    Time frame: Day 7

    Basophils will be measured in thousands/µL

  141. Complete Blood Count in Patients after the walking test: Basophils

    Time frame: Day 0

    Basophils will be measured in thousands/µL

  142. Complete Blood Count in Patients after the walking test: Basophils

    Time frame: Day 7

    Basophils will be measured in thousands/µL

  143. NETosis markers in Controls before the walking test

    Time frame: Day 0

    Fluorescence signal intensity of neutrophils will be measured on a SYSMEX automat

  144. NETosis markers in Controls after the walking test

    Time frame: Day 0

    Fluorescence signal intensity of neutrophils will be measured on a SYSMEX automat

  145. NETosis markers in Patients before the walking test

    Time frame: Day 7

    Fluorescence signal intensity of neutrophils will be measured on a SYSMEX automat

  146. NETosis markers in Patients after the walking test

    Time frame: Day 7

    Fluorescence signal intensity of neutrophils will be measured on a SYSMEX automat

  147. NETosis markers in Controls before the walking test: reacting monocytes

    Time frame: Day 0

    The percentage of reacting monocytes will be measured on a SYSMEX automat

  148. NETosis markers in Controls after the walking test: reacting monocytes

    Time frame: Day 0

    The percentage of reacting monocytes will be measured on a SYSMEX automat

  149. NETosis markers in Controls before the walking test: reacting monocytes

    Time frame: Day 7

    The percentage of reacting monocytes will be measured on a SYSMEX automat

  150. NETosis markers in Controls after the walking test: reacting monocytes

    Time frame: Day 7

    The percentage of reacting monocytes will be measured on a SYSMEX automat

  151. NETosis markers in Controls before the walking test: reacting lymphocytes

    Time frame: Day 0

    The percentage of reacting lymphocytes will be measured on a SYSMEX automat

  152. NETosis markers in Controls after the walking test: reacting lymphocytes

    Time frame: Day 0

    The percentage of reacting lymphocytes will be measured on a SYSMEX automat

  153. NETosis markers in Patients before the walking test: reacting lymphocytes

    Time frame: Day 7

    The percentage of reacting lymphocytes will be measured on a SYSMEX automat

  154. NETosis markers in Patients after the walking test: reacting lymphocytes

    Time frame: Day 7

    The percentage of reacting lymphocytes will be measured on a SYSMEX automat

  155. NETosis markers in Controls before the walking test:

    Time frame: Day 0

    The percentage of reacting lymphocytes will be measured on a SYSMEX automat

  156. NETosis markers in Controls after the walking test: circulating citrulinated histone H3

    Time frame: Day 0

    The percentage of circulating citrulinated histone H3 will be measured on a SYSMEX automat

  157. NETosis markers in Patients before the walking test: circulating citrulinated histone H3

    Time frame: Day 7

    The percentage of circulating citrulinated histone H3 will be measured on a SYSMEX automat

  158. NETosis markers in Patients after the walking test: circulating citrulinated histone H3

    Time frame: Day 7

    The percentage of circulating citrulinated histone H3 will be measured on a SYSMEX automat

  159. Coagulation factors in Controls before the walking test: fibrinogen

    Time frame: Day 0

    Fibrinogen will be measured in g/L

  160. Coagulation factors in Controls before the walking test

    Time frame: Day 0

    Coagulation factors XI, IX, VIII, VII, V, X and II will be measured in International Units

  161. Coagulation factors in Controls after the walking test: fibrinogen

    Time frame: Day 0

    Fibrinogen will be measured in g/L

  162. Coagulation factors in Controls after the walking test

    Time frame: Day 0

    Coagulation factors XI, IX, VIII, VII, V, X and II will be measured in International Units

  163. Coagulation factors in Patients before the walking test: fibrinogen

    Time frame: Day 7

    Fibrinogen will be measured in g/L

  164. Coagulation factors in Patients before the walking test

    Time frame: Day 7

    Coagulation factors XI, IX, VIII, VII, V, X and II will be measured in International Units

  165. Coagulation factors in Patients after the walking test: fibrinogen

    Time frame: Day 7

    Fibrinogen will be measured in g/L

  166. Coagulation factors in Patients after the walking test

    Time frame: Day 7

    Coagulation factors XI, IX, VIII, VII, V, X and II will be measured in International Units

  167. Indicators of fibrinoformation in Controls before the walking test: circulating fibrin monomers

    Time frame: Day 0

    Circulating fibrin monomers will be measured in fibrinogen equivalent units

  168. Indicators of fibrinoformation in Controls after the walking test: circulating fibrin monomers

    Time frame: Day 0

    Circulating fibrin monomers will be measured in fibrinogen equivalent units

  169. Indicators of fibrinoformation in Controls before the walking test: circulating fibrin monomers

    Time frame: Day 7

    Circulating fibrin monomers will be measured in fibrinogen equivalent units

  170. Indicators of fibrinoformation in Controls after the walking test: circulating fibrin monomers

    Time frame: Day 7

    Circulating fibrin monomers will be measured in fibrinogen equivalent units

  171. Indicators of fibrinoformation in Patients before the walking test: circulating fibrin monomers

    Time frame: Day 0

    Circulating fibrin monomers will be measured in fibrinogen equivalent units

  172. Indicators of fibrinoformation in Patients after the walking test: circulating fibrin monomers

    Time frame: Day 0

    Circulating fibrin monomers will be measured in fibrinogen equivalent units

  173. Indicators of fibrinoformation in Patients before the walking test: circulating fibrin monomers

    Time frame: Day 7

    Circulating fibrin monomers will be measured in fibrinogen equivalent units

  174. Indicators of fibrinoformation in Patients after the walking test: circulating fibrin monomers

    Time frame: Day 7

    Circulating fibrin monomers will be measured in fibrinogen equivalent units

  175. Indicators of fibrinoformation in Controls before the walking test: D-dimers

    Time frame: Day 0

    D-dimers will be measured in DDUs

  176. Indicators of fibrinoformation in Controls after the walking test: D-dimers

    Time frame: Day 0

    D-dimers will be measured in DDUs

  177. Indicators of fibrinoformation in Patients before the walking test: D-dimers

    Time frame: Day 0

    D-dimers will be measured in DDUs

  178. Indicators of fibrinoformation in Patients after the walking test: D-dimers

    Time frame: Day 0

    D-dimers will be measured in DDUs

  179. Indicators of fibrinoformation in Controls before the walking test: D-dimers

    Time frame: Day 7

    D-dimers will be measured in DDUs

  180. Indicators of fibrinoformation in Controls after the walking test: D-dimers

    Time frame: Day 7

    D-dimers will be measured in DDUs

  181. Indicators of fibrinoformation in Patients before the walking test: D-dimers

    Time frame: Day 7

    D-dimers will be measured in DDUs

  182. Indicators of fibrinoformation in Patients after the walking test: D-dimers

    Time frame: Day 7

    D-dimers will be measured in DDUs

  183. Markers of fibrinolysis in Controls before the walking test : Euglobulin lysis time

    Time frame: Day 0

    Euglobulin lysis time will be measured in hours

  184. Markers of fibrinolysis in Controls after the walking test : Euglobulin lysis time

    Time frame: Day 0

    Euglobulin lysis time will be measured in hours

  185. Markers of fibrinolysis in Patients before the walking test : Euglobulin lysis time

    Time frame: Day 0

    Euglobulin lysis time will be measured in hours

  186. Markers of fibrinolysis in Patients after the walking test : Euglobulin lysis time

    Time frame: Day 0

    Euglobulin lysis time will be measured in hours

  187. Markers of fibrinolysis in Controls before the walking test : Euglobulin lysis time

    Time frame: Day 7

    Euglobulin lysis time will be measured in hours

  188. Markers of fibrinolysis in Controls after the walking test : Euglobulin lysis time

    Time frame: Day 7

    Euglobulin lysis time will be measured in hours

  189. Markers of fibrinolysis in Patients before the walking test : Euglobulin lysis time

    Time frame: Day 7

    Euglobulin lysis time will be measured in hours

  190. Markers of fibrinolysis in Patients after the walking test : Euglobulin lysis time

    Time frame: Day 7

    Euglobulin lysis time will be measured in hours

  191. Markers of Endothelial function in Controls before the walking test: Willebrand factor

    Time frame: Day 0

    Willebrand factor will be measured as a %

  192. Markers of Endothelial function in Controls after the walking test: Willebrand factor

    Time frame: Day 0

    Willebrand factor will be measured as a %

  193. Markers of Endothelial function in Patients before the walking test: Willebrand factor

    Time frame: Day 0

    Willebrand factor will be measured as a %

  194. Markers of Endothelial function in Patients after the walking test: Willebrand factor

    Time frame: Day 0

    Willebrand factor will be measured as a %

  195. Markers of Endothelial function in Controls before the walking test: Willebrand factor

    Time frame: Day 7

    Willebrand factor will be measured as a %

  196. Markers of Endothelial function in Controls after the walking test: Willebrand factor

    Time frame: Day 7

    Willebrand factor will be measured as a %

  197. Markers of Endothelial function in Patients before the walking test: Willebrand factor

    Time frame: Day 7

    Willebrand factor will be measured as a %

  198. Markers of Endothelial function in Patients after the walking test: Willebrand factor

    Time frame: Day 7

    Willebrand factor will be measured as a%

  199. Markers of Endothelial function in Controls before the walking test: ristocetin cofactor

    Time frame: Day 0

    Ristocetin cofactor will be measured as a %

  200. Markers of Endothelial function in Controls after the walking test: ristocetin cofactor

    Time frame: Day 0

    Ristocetin cofactor will be measured as a %

  201. Markers of Endothelial function in Patients before the walking test: ristocetin cofactor

    Time frame: Day 0

    Ristocetin cofactor will be measured as a %

  202. Markers of Endothelial function in Patients after the walking test: ristocetin cofactor

    Time frame: Day 0

    Ristocetin cofactor will be measured as a %

  203. Markers of Endothelial function in Controls before the walking test: ristocetin cofactor

    Time frame: Day 7

    Ristocetin cofactor will be measured as a %

  204. Markers of Endothelial function in Controls after the walking test: ristocetin cofactor

    Time frame: Day 7

    Ristocetin cofactor will be measured as a %

  205. Markers of Endothelial function in Patients before the walking test: ristocetin cofactor

    Time frame: Day 7

    Ristocetin cofactor will be measured as a %

  206. Markers of Endothelial function in Patients after the walking test: ristocetin cofactor

    Time frame: Day 7

    Ristocetin cofactor will be measured as a %

  207. Markers of Endothelial function in Controls before the walking test: ADAMTS-13 activity

    Time frame: Day 0

    ADAMTS-13 activity will be measured as a %

  208. Markers of Endothelial function in Controls after the walking test: ADAMTS-13 activity

    Time frame: Day 0

    ADAMTS-13 activity will be measured as a %

  209. Markers of Endothelial function in Patients before the walking test: ADAMTS-13 activity

    Time frame: Day 0

    ADAMTS-13 activity will be measured as a %

  210. Markers of Endothelial function in Patients after the walking test: ADAMTS-13 activity

    Time frame: Day 0

    ADAMTS-13 activity will be measured as a %

  211. Markers of Endothelial function in Controls before the walking test: ADAMTS-13 activity

    Time frame: Day 7

    ADAMTS-13 activity will be measured as a %

  212. Markers of Endothelial function in Controls after the walking test: ADAMTS-13 activity

    Time frame: Day 7

    ADAMTS-13 activity will be measured as a %

  213. Markers of Endothelial function in Patients before the walking test: ADAMTS-13 activity

    Time frame: Day 7

    ADAMTS-13 activity will be measured as a %

  214. Markers of Endothelial function in Patients after the walking test: ADAMTS-13 activity

    Time frame: Day 7

    ADAMTS-13 activity will be measured as a %

  215. Markers of Endothelial function in Controls before the walking test: soluble thrombomodulin

    Time frame: Day 0

    Soluble thrombomodulin will be measured as a %

  216. Markers of Endothelial function in Controls after the walking test: soluble thrombomodulin

    Time frame: Day 0

    Soluble thrombomodulin will be measured as a %

  217. Markers of Endothelial function in Patients before the walking test: soluble thrombomodulin

    Time frame: Day 0

    Soluble thrombomodulin will be measured as a %

  218. Markers of Endothelial function in Patients after the walking test: soluble thrombomodulin

    Time frame: Day 0

    Soluble thrombomodulin will be measured as a %

  219. Markers of Endothelial function in Controls before the walking test: soluble thrombomodulin

    Time frame: Day 7

    Soluble thrombomodulin will be measured as a %

  220. Markers of Endothelial function in Controls after the walking test: soluble thrombomodulin

    Time frame: Day 7

    Soluble thrombomodulin will be measured as a %

  221. Markers of Endothelial function in Patients before the walking test: soluble thrombomodulin

    Time frame: Day 7

    Soluble thrombomodulin will be measured as a %

  222. Markers of Endothelial function in Patients after the walking test: soluble thrombomodulin

    Time frame: Day 7

    Soluble thrombomodulin will be measured as a %

  223. Markers of Endothelial function in Controls before the walking test: soluble endothelial protein C receptor

    Time frame: Day 0

    Soluble endothelial protein C receptor will be measured as a %

  224. Markers of Endothelial function in Controls after the walking test: soluble endothelial protein C receptor

    Time frame: Day 0

    Soluble endothelial protein C receptor will be measured as a %

  225. Markers of Endothelial function in Patients before the walking test: soluble endothelial protein C receptor

    Time frame: Day 0

    Soluble endothelial protein C receptor will be measured as a %

  226. Markers of Endothelial function in Patients after the walking test: soluble endothelial protein C receptor

    Time frame: Day 0

    Soluble endothelial protein C receptor will be measured as a %

  227. Markers of Endothelial function in Controls before the walking test: soluble endothelial protein C receptor

    Time frame: Day 7

    Soluble endothelial protein C receptor will be measured as a %

  228. Markers of Endothelial function in Controls after the walking test: soluble endothelial protein C receptor

    Time frame: Day 7

    Soluble endothelial protein C receptor will be measured as a %

  229. Markers of Endothelial function in Patients before the walking test: soluble endothelial protein C receptor

    Time frame: Day 7

    Soluble thrombomodulin will be measured as a %

  230. Markers of Endothelial function in Patients after the walking test: soluble endothelial protein C receptor

    Time frame: Day 7

    Soluble thrombomodulin will be measured as a %

Other outcomes

  1. Age in Controls

    Time frame: Day 0

    Ages will be recorded in years

  2. Sex in Controls

    Time frame: Day 0

    Sex will be recorded as Male/Female/Non-binary

  3. Body mass index in Controls

    Time frame: Day 0

    Body mass index of controls will be recorded in units of kg/m²

  4. Age in Patients

    Time frame: Day 0

    Ages will be recorded in years

  5. Sex in Patients

    Time frame: Day 0

    Sex will be recorded as Male/Female/Non-binary

  6. Body Mass Index in Patients

    Time frame: Day 0

    Body mass index of controls will be recorded in units of kg/m²

Study contacts

Contact information is provided by the study sponsor or research team.

Anissa MEGZARI

CONTACT

[email protected]

+33466684236

Antonia PEREZ MARTIN, Prof.

CONTACT

[email protected]

+334 66 68 33 13

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study title

Variations in the Hemostatic System Induced by a Standardized Walking Test: Controls vs. Cases With a History of Non-anticoagulated Venous Thromboembolic Disease

Acronym: FAST&THROMBIN

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
May 17, 2024
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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