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NCT Number: NCT06571552

Coagulation Disorders Secondary to Two Plasmapheresis Techniques (Double Filtration Plasmapheresis vs. PFS). Descriptive Pilot Study.

Therapeutic plasmapheresis causes changes in haemostasis by purifying many of the circulating factors involved. Few reliable data are available on these changes and most studies are limited to coagulation factor assays before and after the session, with little data documenting the kinetics of regeneration of these factors. It is recognized that haemostasis disorders caused by therapeutic apheresis must be corrected in cases of active bleeding. However the methods of correcting these disorders are debatable. Finally, it is unclear when changes in haemostasis associated with coagulation factor deficiency should be corrected. Haemostasis is probably not based solely on the level of blood fibrinogen, but it is most often its threshold that is used to trigger replacement therapy to prevent a supposed risk of haemorrhage. No studies are available on the kinetics of haemostasis disorders and the risk of haemorrhage following a therapeutic plasmapheresis session, according to session type and fibrinogen level at the end of the session. The hypothesis of this research is that the link between fibrinogen level and thrombin generation capacity, post therapeutic plasmapheresis, will enable us to better assess the risk of haemorrhage and propose preventive measures.

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Key information

Conditions

Hyperfibrinogenemia Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorder Hemostatic Disorders Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Nîmes

Nîmes, 30029, France

Location status: Recruiting

Location contact

Anne Clarisse SIMONET, PhD

CONTACT

[email protected]

04.66.68.51.48

Olivier MORANNE, MD

PRINCIPAL_INVESTIGATOR

About this study

Therapeutic plasmapheresis causes changes in haemostasis by purifying many of the circulating factors involved. Some data are available on changes in circulating haemostasis factors with the Single Plasma Exchange technique and the Double Filtration Plasmapheresis; however, most often these studies are carried out in specific clinical situations where other haemostasis disorders may be present, such as severe renal failure. Furthermore, in these studies, assessment of changes in haemostasis is often limited to coagulation factor assays before and after the session, with little data documenting the kinetics of regeneration of these factors, whose molecular weight and half-life vary widely. To date, there is no clear consensus/recommendation on the management of haemostasis disorders secondary to therapeutic apheresis. The need to correct haemostasis disorders caused by therapeutic apheresis also appears to be consensual in cases of active bleeding.The methods of correcting haemostasis disorders can also be discussed between infusion of coagulation factor and fresh frozen plasma. Finally, apart from these clinical situations, it is not clear when changes in haemostasis associated with coagulation factor deficiency should be corrected. There are no studies available on the kinetics of haemostasis disorders and the risk of haemorrhage following a therapeutic plasmapheresis session, depending on the type of session and the fibrinogen level at the end of the session. The hypothesis of our research is that the existence of a link between fibrinogen level and thrombin generation capacity, post therapeutic plasmapheresis, will enable us to better assess the risk of haemorrhage and to propose preventive measures.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients without renal failure treated with chronic therapeutic plasmapheresis with a minimum treatment interval of 10 days and who can be treated with single plasma exchange (SPE) or double filtration plasmapheresis (DFPP) in accordance with the international recommendations.
  • Therapeutic plasmapheresis with regional citrate anticoagulation.
  • Patients over 18 years of age.
  • Patient affiliated to or benefiting from a social security scheme.
  • Free, informed and written consent, signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research).

Exclusion criteria

  • Patients treated with oral anticoagulants or anti-platelet agents.
  • Patients treated for hypercholesterolaemia or hypertriglyceridaemia; hyperviscosity, acquired haemophilia or nephrotic syndrome.
  • Indication for substitution with fresh frozen plasma (FFP) for the treatment of the disease.
  • Patient in an exclusion period determined by another study.
  • Patient under court protection, guardianship or curatorship.
  • Patient unable to give consent.
  • Patient for whom it is impossible to give informed information.
  • Pregnant or breast-feeding patients.

Treatment and study plan

Single Plasma Exchange followed by Double Filtration Plasmapheresis

Procedure

Double Filtration Plasmapheresis followed by Single Plasma Exchange

Primary outcomes

  1. Determination of fibrinogen levels before the first plasmapheresis session with single plasma exchange

    Time frame: Day 0, before the session

    Clauss functional method, g/L

  2. Determination of fibrinogen levels with Génésia® before the first plasmapheresis session with single plasma exchange

    Time frame: Day 0, before the session

    Automated thrombin generation test on Génésia®.

  3. Determination of fibrinogen levels after the first plasmapheresis session with single plasma exchange

    Time frame: Day 0, end of session

    Clauss functional method, g/L

  4. Determination of fibrinogen levels with Génésia® after the first plasmapheresis session with single plasma exchange

    Time frame: Day 0, end of session

    Automated thrombin generation test on Génésia®.

  5. Determination of fibrinogen levels after the plasmapheresis session with single plasma exchange

    Time frame: Day 0, 1 hour after the session

    Clauss functional method, g/L

  6. Determination of fibrinogen levels with Genesia® after the plasmapheresis session with single plasma exchange

    Time frame: Day 0, 1 hour after the session

    Automated thrombin generation test on Génésia®.

  7. Determination of fibrinogen levels after the plasmapheresis session with single plasma exchange

    Time frame: Day 0, 4 hours after the session

    Clauss functional method, g/L

  8. Determination of fibrinogen levels with Genesia® after the plasmapheresis session with single plasma exchange

    Time frame: Day 0, 4 hours after the session

    Automated thrombin generation test on Génésia®.

  9. Determination of fibrinogen levels before the plasmapheresis session with single plasma exchange

    Time frame: Day 1

    Clauss functional method, g/L

  10. Determination of fibrinogen levels with Genesia® before the plasmapheresis session with single plasma exchange

    Time frame: Day 1

    Automated thrombin generation test on Génésia®.

  11. Determination of fibrinogen levels before the plasmapheresis session with single plasma exchange

    Time frame: Day 3

    Clauss functional method, g/L

  12. Determination of fibrinogen levels with Genesia® before the plasmapheresis session with single plasma exchange

    Time frame: Day 3

    Automated thrombin generation test on Génésia®.

  13. Determination of fibrinogen levels after the plasmapheresis session with single plasma exchange

    Time frame: Month 1, Day 1, 1 hour after the session

    Clauss functional method, g/L

  14. Determination of fibrinogen levels with Genesia® after the plasmapheresis session with single plasma exchange

    Time frame: Month 1, Day 1, 1 hour after the session

    Automated thrombin generation test on Génésia®.

  15. Determination of fibrinogen levels after the plasmapheresis session with single plasma exchange

    Time frame: Month 1, Day 4, 4 hours after the session

    Clauss functional method, g/L

  16. Determination of fibrinogen levels with Genesia® after the plasmapheresis session with single plasma exchange

    Time frame: Month 1, Day 4, 4 hours after the session

    Automated thrombin generation test on Génésia®.

  17. Determination of fibrinogen levels after the plasmapheresis session with single plasma exchange

    Time frame: Month 1, Day 3

    Clauss functional method, g/L

  18. Determination of fibrinogen levels with Genesia® after the plasmapheresis session with single plasma exchange

    Time frame: Month 1, Day 3

    Automated thrombin generation test on Génésia®.

  19. Determination of fibrinogen levels before the first plasmapheresis session with double filtration plasmapheresis

    Time frame: Day 0, before the session

    Clauss functional method, g/L

  20. Determination of fibrinogen levels with Génésia® before the first plasmapheresis session with double filtration plasmapheresis

    Time frame: Day 0, before the session

    Automated thrombin generation test on Génésia®.

  21. Determination of fibrinogen levels after the first plasmapheresis session with double filtration plasmapheresis

    Time frame: Day 0, end of session

    Clauss functional method, g/L

  22. Determination of fibrinogen levels with Génésia® after the first plasmapheresis session with double filtration plasmapheresis

    Time frame: Day 0, end of session

    Automated thrombin generation test on Génésia®.

  23. Determination of fibrinogen levels after the first plasmapheresis session with double filtration plasmapheresis

    Time frame: Day 0, 1 hour after the session

    Clauss functional method, g/L

  24. Determination of fibrinogen levels with Génésia® after the first plasmapheresis session with double filtration plasmapheresis

    Time frame: Day 0, 1 hour after the session

    Automated thrombin generation test on Génésia®.

  25. Determination of fibrinogen levels after the first plasmapheresis session with double filtration plasmapheresis

    Time frame: Day 0, 4 hours after the session

    Clauss functional method, g/L

  26. Determination of fibrinogen levels with Génésia® after the first plasmapheresis session with double filtration plasmapheresis

    Time frame: Day 0, 4 hours after the session

    Automated thrombin generation test on Génésia®.

  27. Determination of fibrinogen levels before the plasmapheresis session with double filtration plasmapheresis

    Time frame: Day 1

    Clauss functional method, g/L

  28. Determination of fibrinogen levels with Génésia® before the plasmapheresis session with double filtration plasmapheresis

    Time frame: Day 1

    Automated thrombin generation test on Génésia®.

  29. Determination of fibrinogen levels before the plasmapheresis session with double filtration plasmapheresis

    Time frame: Day 3

    Clauss functional method, g/L

  30. Determination of fibrinogen levels with Génésia® before the plasmapheresis session with double filtration plasmapheresis

    Time frame: Day 3

    Automated thrombin generation test on Génésia®.

  31. Determination of fibrinogen levels after the plasmapheresis session with double filtration plasmapheresis

    Time frame: Month 1, Day 1, 1 hour after the session

    Clauss functional method, g/L

  32. Determination of fibrinogen levels with Génésia® after the plasmapheresis session with double filtration plasmapheresis

    Time frame: Month 1, Day 1, 1 hour after the session

    Automated thrombin generation test on Génésia®.

  33. Determination of fibrinogen levels after the plasmapheresis session with double filtration plasmapheresis

    Time frame: Month 1, Day 1, 4 hours after the session

    Clauss functional method, g/L

  34. Determination of fibrinogen levels with Génésia® after the plasmapheresis session with double filtration plasmapheresis

    Time frame: Month 1, Day 1, 4 hours after the session

    Automated thrombin generation test on Génésia®.

  35. Determination of fibrinogen levels after the plasmapheresis session with double filtration plasmapheresis

    Time frame: Month 1, Day 3

    Clauss functional method, g/L

  36. Determination of fibrinogen levels with Génésia® after the plasmapheresis session with double filtration plasmapheresis

    Time frame: Month 1, Day 3

    Automated thrombin generation test on Génésia®.

Secondary outcomes

  1. Complete blood count before the plasmapheresis session with single plasma exchange : White blood cells

    Time frame: Day 0, Hour 0

    Quantitative, per microliter

  2. Complete blood count after the plasmapheresis session with single plasma exchange : White blood cells

    Time frame: Day 0, Hour 1

    Quantitative, per microliter

  3. Complete blood count after the plasmapheresis session with single plasma exchange : White blood cells

    Time frame: Day 0, Hour 4

    Quantitative, per microliter

  4. Complete blood count after the plasmapheresis session with single plasma exchange : White blood cells

    Time frame: Day 1

    Quantitative, per microliter

  5. Complete blood count after the plasmapheresis session with single plasma exchange : White blood cells

    Time frame: Day 3

    Quantitative, per microliter

  6. Complete blood count before the plasmapheresis session with single plasma exchange : Red blood cells

    Time frame: Day 0, Hour 0

    Quantitative, per microliter

  7. Complete blood count after the plasmapheresis session with single plasma exchange : Red blood cells

    Time frame: Day 0, Hour 1

    Quantitative, per microliter

  8. Complete blood count after the plasmapheresis session with single plasma exchange : Red blood cells

    Time frame: Day 0, Hour 4

    Quantitative, per microliter

  9. Complete blood count after the plasmapheresis session with single plasma exchange : Red blood cells

    Time frame: Day 1

    Quantitative, per microliter

  10. Complete blood count after the plasmapheresis session with single plasma exchange : Red blood cells

    Time frame: Day 3

    Quantitative, per microliter

  11. Complete blood count before the plasmapheresis session with single plasma exchange : Hemoglobin

    Time frame: Day 0, Hour 0

    Quantitative, grams per liter

  12. Complete blood count after the plasmapheresis session with single plasma exchange : Hemoglobin

    Time frame: Day 0, Hour 1

    Quantitative, grams per liter

  13. Complete blood count after the plasmapheresis session with single plasma exchange : Hemoglobin

    Time frame: Day 0, Hour 4

    Quantitative, grams per liter

  14. Complete blood count after the plasmapheresis session with single plasma exchange : Hemoglobin

    Time frame: Day 1

    Quantitative, grams per liter

  15. Complete blood count after the plasmapheresis session with single plasma exchange : Hemoglobin

    Time frame: Day 3

    Quantitative, grams per liter

  16. Complete blood count before the plasmapheresis session with single plasma exchange : Platelets

    Time frame: Day 0, Hour 0

    Quantitative, %

  17. Complete blood count after the plasmapheresis session with single plasma exchange : Platelets

    Time frame: Day 0, Hour 1

    Quantitative, %

  18. Complete blood count after the plasmapheresis session with single plasma exchange : Platelets

    Time frame: Day 0, Hour 4

    Quantitative, %

  19. Complete blood count after the plasmapheresis session with single plasma exchange : Platelets

    Time frame: Day 1

    Quantitative, %

  20. Complete blood count after the plasmapheresis session with single plasma exchange : Platelets

    Time frame: Day 3

    Quantitative, %

  21. Complete blood count before the plasmapheresis session with single plasma exchange : Neutrophils

    Time frame: Day 0, Hour 0

    Quantitative, per microliter

  22. Complete blood count after the plasmapheresis session with single plasma exchange : Neutrophils

    Time frame: Day 0, Hour 1

    Quantitative, per microliter

  23. Complete blood count after the plasmapheresis session with single plasma exchange : Neutrophils

    Time frame: Day 0, Hour 4

    Quantitative, per microliter

  24. Complete blood count after the plasmapheresis session with single plasma exchange : Neutrophils

    Time frame: Day 1

    Quantitative, per microliter

  25. Complete blood count after the plasmapheresis session with single plasma exchange : Neutrophils

    Time frame: Day 3

    Quantitative, per microliter

  26. Complete blood count before the plasmapheresis session with single plasma exchange : Lymphocytes

    Time frame: Day 0, Hour 0

    Quantitative, per microliter

  27. Complete blood count after the plasmapheresis session with single plasma exchange : Lymphocytes

    Time frame: Day 0, Hour 1

    Quantitative, per microliter

  28. Complete blood count after the plasmapheresis session with single plasma exchange : Lymphocytes

    Time frame: Day 0, Hour 4

    Quantitative, per microliter

  29. Complete blood count after the plasmapheresis session with single plasma exchange : Lymphocytes

    Time frame: Day 1

    Quantitative, per microliter

  30. Complete blood count after the plasmapheresis session with single plasma exchange : Lymphocytes

    Time frame: Day 3

    Quantitative, per microliter

  31. Complete blood count before the plasmapheresis session with single plasma exchange : Monocytes

    Time frame: Day 0, Hour 0

    Quantitative, per microliter

  32. Complete blood count after the plasmapheresis session with single plasma exchange : Monocytes

    Time frame: Day 0, Hour 1

    Quantitative, per microliter

  33. Complete blood count after the plasmapheresis session with single plasma exchange : Monocytes

    Time frame: Day 0, Hour 4

    Quantitative, per microliter

  34. Complete blood count after the plasmapheresis session with single plasma exchange : Monocytes

    Time frame: Day 1

    Quantitative, per microliter

  35. Complete blood count after the plasmapheresis session with single plasma exchange : Monocytes

    Time frame: Day 3

    Quantitative, per microliter

  36. Complete blood count before the plasmapheresis session with single plasma exchange : Eosinophils

    Time frame: Day 0, Hour 0

    Quantitative, per microliter

  37. Complete blood count after the plasmapheresis session with single plasma exchange : Eosinophils

    Time frame: Day 0, Hour 1

    Quantitative, per microliter

  38. Complete blood count after the plasmapheresis session with single plasma exchange : Eosinophils

    Time frame: Day 0, Hour 4

    Quantitative, per microliter

  39. Complete blood count after the plasmapheresis session with single plasma exchange : Eosinophils

    Time frame: Day 1

    Quantitative, per microliter

  40. Complete blood count after the plasmapheresis session with single plasma exchange : Eosinophils

    Time frame: Day 3

    Quantitative, per microliter

  41. Complete blood count before the plasmapheresis session with single plasma exchange : Basophils

    Time frame: Day 0, Hour 0

    Quantitative, per microliter

  42. Complete blood count after the plasmapheresis session with single plasma exchange : Basophils

    Time frame: Day 0, Hour 1

    Quantitative, per microliter

  43. Complete blood count after the plasmapheresis session with single plasma exchange : Basophils

    Time frame: Day 0, Hour 4

    Quantitative, per microliter

  44. Complete blood count after the plasmapheresis session with single plasma exchange : Basophils

    Time frame: Day 1

    Quantitative, per microliter

  45. Complete blood count after the plasmapheresis session with single plasma exchange : Basophils

    Time frame: Day 3

    Quantitative, per microliter

  46. Complete blood count before the plasmapheresis session with single plasma exchange : Hematocrit

    Time frame: Day 0, Hour 0

    Quantitative, %

  47. Complete blood count after the plasmapheresis session with single plasma exchange : Hematocrit

    Time frame: Day 0, Hour 1

    Quantitative, %

  48. Complete blood count after the plasmapheresis session with single plasma exchange : Hematocrit

    Time frame: Day 0, Hour 4

    Quantitative, %

  49. Complete blood count after the plasmapheresis session with single plasma exchange : Hematocrit

    Time frame: Day 1

    Quantitative, %

  50. Complete blood count after the plasmapheresis session with single plasma exchange : Hematocrit

    Time frame: Day 3

    Quantitative, %

  51. Complete blood count before the plasmapheresis session with single plasma exchange : Mean Corpuscular Volume

    Time frame: Day 0, Hour 0

    Quantitative, %

  52. Complete blood count after the plasmapheresis session with single plasma exchange : Mean Corpuscular Volume

    Time frame: Day 0, Hour 1

    Quantitative, %

  53. Complete blood count after the plasmapheresis session with single plasma exchange : Mean Corpuscular Volume

    Time frame: Day 0, Hour 4

    Quantitative, %

  54. Complete blood count after the plasmapheresis session with single plasma exchange : Mean Corpuscular Volume

    Time frame: Day 1

    Quantitative, %

  55. Complete blood count after the plasmapheresis session with single plasma exchange : Mean Corpuscular Volume

    Time frame: Day 4

    Quantitative, %

  56. Complete blood count before the plasmapheresis session with single plasma exchange : Mean Corpuscular Hemoglobin

    Time frame: Day 0, Hour 0

    Quantitative, in pg

  57. Complete blood count after the plasmapheresis session with single plasma exchange : Mean Corpuscular Hemoglobin

    Time frame: Day 0, Hour 1

    Quantitative, in pg

  58. Complete blood count after the plasmapheresis session with single plasma exchange : Mean Corpuscular Hemoglobin

    Time frame: Day 0, Hour 4

    Quantitative, in pg

  59. Complete blood count after the plasmapheresis session with single plasma exchange : Mean Corpuscular Hemoglobin

    Time frame: Day 1

    Quantitative, in pg

  60. Complete blood count after the plasmapheresis session with single plasma exchange : Mean Corpuscular Hemoglobin

    Time frame: Day 3

    Quantitative, in pg

  61. Complete blood count before the plasmapheresis session with single plasma exchange : Mean Corpuscular Hemoglobin Concentration

    Time frame: Day 0, Hour 0

    Quantitative, in g/L

  62. Complete blood count after the plasmapheresis session with single plasma exchange : Mean Corpuscular Hemoglobin Concentration

    Time frame: Day 0, Hour 1

    Quantitative, in g/L

  63. Complete blood count after the plasmapheresis session with single plasma exchange : Mean Corpuscular Hemoglobin Concentration

    Time frame: Day 0, Hour 4

    Quantitative, in g/L

  64. Complete blood count after the plasmapheresis session with single plasma exchange : Mean Corpuscular Hemoglobin Concentration

    Time frame: Day 1

    Quantitative, in g/L

  65. Complete blood count after the plasmapheresis session with single plasma exchange : Mean Corpuscular Hemoglobin Concentration

    Time frame: Day 3

    Quantitative, in g/L

  66. Serum albumin before the plasmapheresis session with single plasma exchange

    Time frame: Day 0, Hour 0

    Quantitative, in g/dL

  67. Serum albumin after the plasmapheresis session with single plasma exchange

    Time frame: Day 0, Hour 1

    Quantitative, in g/dL

  68. Serum albumin after the plasmapheresis session with single plasma exchange

    Time frame: Day 0, Hour 4

    Quantitative, in g/dL

  69. Serum albumin after the plasmapheresis session with single plasma exchange

    Time frame: Day 1

    Quantitative, in g/dL

  70. Serum albumin after the plasmapheresis session with single plasma exchange

    Time frame: Day 3

    Quantitative, in g/dL

  71. Prothrombin Time Test and International Normalized Ratio (PT/INR) before the plasmapheresis session with single plasma exchange

    Time frame: Day 0, Hour 0

    In seconds

  72. Prothrombin Time Test and International Normalized Ratio (PT/INR) after the plasmapheresis session with single plasma exchange

    Time frame: Day 0, Hour 1

    In seconds

  73. Prothrombin Time Test and International Normalized Ratio (PT/INR) after the plasmapheresis session with single plasma exchange

    Time frame: Day 0, Hour 4

    In seconds

  74. Prothrombin Time Test and International Normalized Ratio (PT/INR) after the plasmapheresis session with single plasma exchange

    Time frame: Day 1

    In seconds

  75. Prothrombin Time Test and International Normalized Ratio (PT/INR) after the plasmapheresis session with single plasma exchange

    Time frame: Day 3

    In seconds

  76. Factors VIII, IX, XI and XII before the plasmapheresis session with single plasma exchange

    Time frame: Day 0, Hour 0

    By 1-stage APTT-based Factor assay, in seconds

  77. Factors VIII, IX, XI and XII after the plasmapheresis session with single plasma exchange

    Time frame: Day 0, Hour 1

    By 1-stage APTT-based Factor assay, in seconds

  78. Factors VIII, IX, XI and XII after the plasmapheresis session with single plasma exchange

    Time frame: Day 0, Hour 4

    By 1-stage APTT-based Factor assay, in seconds

  79. Factors VIII, IX, XI and XII after the plasmapheresis session with single plasma exchange

    Time frame: Day 1

    By 1-stage APTT-based Factor assay, in seconds

  80. Factors VIII, IX, XI and XII after the plasmapheresis session with single plasma exchange

    Time frame: Day 3

    By 1-stage APTT-based Factor assay, in seconds

  81. Factors X, V and II [Prothrombin] before the plasmapheresis session with single plasma exchange

    Time frame: Day 0, Hour 0

    Prothrombin assay, in seconds

  82. Factors X, V and II [Prothrombin] after the plasmapheresis session with single plasma exchange

    Time frame: Day 0, Hour 1

    Prothrombin assay, in seconds

  83. Factors X, V and II [Prothrombin] after the plasmapheresis session with single plasma exchange

    Time frame: Day 0, Hour 4

    Prothrombin assay, in seconds

  84. Factors X, V and II [Prothrombin] after the plasmapheresis session with single plasma exchange

    Time frame: Day 1

    Prothrombin assay, in seconds

  85. Factors X, V and II [Prothrombin] after the plasmapheresis session with single plasma exchange

    Time frame: Day 3

    Prothrombin assay, in seconds

  86. D-dimers and circulating soluble fibrin monomers before the plasmapheresis session with single plasma exchange

    Time frame: Day 0, Hour 0

    By enzyme-linked immunosorbent assay (ELISA) method

  87. D-dimers and circulating soluble fibrin monomers after the plasmapheresis session with single plasma exchange

    Time frame: Day 0, Hour 1

    By enzyme-linked immunosorbent assay (ELISA) method

  88. D-dimers and circulating soluble fibrin monomers after the plasmapheresis session with single plasma exchange

    Time frame: Day 0, Hour 4

    By enzyme-linked immunosorbent assay (ELISA) method

  89. D-dimers and circulating soluble fibrin monomers after the plasmapheresis session with single plasma exchange

    Time frame: Day 1

    By enzyme-linked immunosorbent assay (ELISA) method

  90. D-dimers and circulating soluble fibrin monomers after the plasmapheresis session with single plasma exchange

    Time frame: Day 3

    By enzyme-linked immunosorbent assay (ELISA) method

  91. Platelet function test before the plasmapheresis session with single plasma exchange

    Time frame: Day 0, Hour 0

    ADP/collagen and adrenalin/collagen cartridges.

  92. Platelet function test after the plasmapheresis session with single plasma exchange

    Time frame: Day 0, Hour 1

    ADP/collagen and adrenalin/collagen cartridges.

  93. Platelet function test after the plasmapheresis session with single plasma exchange

    Time frame: Day 0, Hour 4

    ADP/collagen and adrenalin/collagen cartridges.

  94. Platelet function test after the plasmapheresis session with single plasma exchange

    Time frame: Day 1

    ADP/collagen and adrenalin/collagen cartridges.

  95. Platelet function test after the plasmapheresis session with single plasma exchange

    Time frame: Day 3

    ADP/collagen and adrenalin/collagen cartridges.

  96. von Willebrand factor (vWF) activity - ristocetin cofactor test before the plasmapheresis session with single plasma exchange

    Time frame: Day 0, Hour 0

    Binding to platelet membrane glycoprotein Ib

  97. von Willebrand factor (vWF) activity - ristocetin cofactor test after the plasmapheresis session with single plasma exchange

    Time frame: Day 0, Hour 1

    Binding to platelet membrane glycoprotein Ib

  98. von Willebrand factor (vWF) activity - ristocetin cofactor test after the plasmapheresis session with single plasma exchange

    Time frame: Day 0, Hour 4

    Binding to platelet membrane glycoprotein Ib

  99. von Willebrand factor (vWF) activity - ristocetin cofactor test after the plasmapheresis session with single plasma exchange

    Time frame: Day 1

    Binding to platelet membrane glycoprotein Ib

  100. von Willebrand factor (vWF) activity - ristocetin cofactor test after the plasmapheresis session with single plasma exchange

    Time frame: Day 3

    Binding to platelet membrane glycoprotein Ib

  101. Thrombin generation test on Génésia® before the plasmapheresis session with single plasma exchange (hemorrhagic exploration version)

    Time frame: Day 0, Hour 0

    Triggered by 1 pM tissue factor

  102. Thrombin generation test on Génésia® after the plasmapheresis session with single plasma exchange (hemorrhagic exploration version)

    Time frame: Day 0, Hour 1

    Triggered by 1 pM tissue factor

  103. Thrombin generation test on Génésia® after the plasmapheresis session with single plasma exchange (hemorrhagic exploration version)

    Time frame: Day 0, Hour 4

    Triggered by 1 pM tissue factor

  104. Thrombin generation test on Génésia® after the plasmapheresis session with single plasma exchange (hemorrhagic exploration version)

    Time frame: Day 1

    Triggered by 1 pM tissue factor

  105. Thrombin generation test on Génésia® after the plasmapheresis session with single plasma exchange (hemorrhagic exploration version)

    Time frame: Day 3

    Triggered by 1 pM tissue factor

  106. Automated thrombin generation test on Génésia® before the plasmapheresis session with single plasma exchange

    Time frame: Day 0, Hour 0

    Triggered by 5 pM tissue factor with response to purified thrombomodulin (thrombotic exploration version)

  107. Automated thrombin generation test on Génésia® after the plasmapheresis session with single plasma exchange

    Time frame: Day 0, Hour 1

    Triggered by 5 pM tissue factor with response to purified thrombomodulin (thrombotic exploration version)

  108. Automated thrombin generation test on Génésia® after the plasmapheresis session with single plasma exchange

    Time frame: Day 0, Hour 4

    Triggered by 5 pM tissue factor with response to purified thrombomodulin (thrombotic exploration version)

  109. Automated thrombin generation test on Génésia® after the plasmapheresis session with single plasma exchange

    Time frame: Day 1

    Triggered by 5 pM tissue factor with response to purified thrombomodulin (thrombotic exploration version)

  110. Automated thrombin generation test on Génésia® after the plasmapheresis session with single plasma exchange

    Time frame: Day 3

    Triggered by 5 pM tissue factor with response to purified thrombomodulin (thrombotic exploration version)

  111. Complete blood count before the double filtration plasmapheresis session : White blood cells

    Time frame: Day 0, Hour 0

    Quantitative, per microliter

  112. Complete blood count after the double filtration plasmapheresis session : White blood cells

    Time frame: Day 0, Hour 1

    Quantitative, per microliter

  113. Complete blood count after the double filtration plasmapheresis session : White blood cells

    Time frame: Day 0, Hour 4

    Quantitative, per microliter

  114. Complete blood count after the double filtration plasmapheresis session : White blood cells

    Time frame: Day 1

    Quantitative, per microliter

  115. Complete blood count after the double filtration plasmapheresis session : White blood cells

    Time frame: Day 3

    Quantitative, per microliter

  116. Complete blood count before the double filtration plasmapheresis session : Red blood cells

    Time frame: Day 0, Hour 0

    Quantitative, per microliter

  117. Complete blood count after the double filtration plasmapheresis session : Red blood cells

    Time frame: Day 0, Hour 1

    Quantitative, per microliter

  118. Complete blood count after the double filtration plasmapheresis session : Red blood cells

    Time frame: Day 0, Hour 4

    Quantitative, per microliter

  119. Complete blood count after the double filtration plasmapheresis session : Red blood cells

    Time frame: Day 1

    Quantitative, per microliter

  120. Complete blood count after the double filtration plasmapheresis session : Red blood cells

    Time frame: Day 4

    Quantitative, per microliter

  121. Complete blood count before the double filtration plasmapheresis session : Hemoglobin

    Time frame: Day 0, Hour 0

    Quantitative, per microliter

  122. Complete blood count after the double filtration plasmapheresis session : Hemoglobin

    Time frame: Day 0, Hour 1

    Quantitative, per microliter

  123. Complete blood count after the double filtration plasmapheresis session : Hemoglobin

    Time frame: Day 0, Hour 4

    Quantitative, per microliter

  124. Complete blood count after the double filtration plasmapheresis session : Hemoglobin

    Time frame: Day 1

    Quantitative, per microliter

  125. Complete blood count after the double filtration plasmapheresis session : Hemoglobin

    Time frame: Day 3

    Quantitative, per microliter

  126. Complete blood count before the double filtration plasmapheresis session : Platelets

    Time frame: Day 0, Hour 0

    Quantitative, %

  127. Complete blood count after the double filtration plasmapheresis session : Platelets

    Time frame: Day 0, Hour 1

    Quantitative, %

  128. Complete blood count after the double filtration plasmapheresis session : Platelets

    Time frame: Day 0, Hour 4

    Quantitative, %

  129. Complete blood count after the double filtration plasmapheresis session : Platelets

    Time frame: Day 1

    Quantitative, %

  130. Complete blood count after the double filtration plasmapheresis session : Platelets

    Time frame: Day 3

    Quantitative, %

  131. Complete blood count before the double filtration plasmapheresis session : Neutrophils

    Time frame: Day 0, Hour 0

    Quantitative, per microliter

  132. Complete blood count after the double filtration plasmapheresis session : Neutrophils

    Time frame: Day 0, Hour 1

    Quantitative, per microliter

  133. Complete blood count after the double filtration plasmapheresis session : Neutrophils

    Time frame: Day 0, Hour 4

    Quantitative, per microliter

  134. Complete blood count after the double filtration plasmapheresis session : Neutrophils

    Time frame: Day 1

    Quantitative, per microliter

  135. Complete blood count after the double filtration plasmapheresis session : Neutrophils

    Time frame: Day 3

    Quantitative, per microliter

  136. Complete blood count before the double filtration plasmapheresis session : Lymphocytes

    Time frame: Day 0, Hour 0

    Quantitative, per microliter

  137. Complete blood count after the double filtration plasmapheresis session : Lymphocytes

    Time frame: Day 0, Hour 1

    Quantitative, per microliter

  138. Complete blood count after the double filtration plasmapheresis session : Lymphocytes

    Time frame: Day 0, Hour 4

    Quantitative, per microliter

  139. Complete blood count after the double filtration plasmapheresis session : Lymphocytes

    Time frame: Day 1

    Quantitative, per microliter

  140. Complete blood count after the double filtration plasmapheresis session : Lymphocytes

    Time frame: Day 3

    Quantitative, per microliter

  141. Complete blood count before the double filtration plasmapheresis session : Monocytes

    Time frame: Day 0, Hour 0

    Quantitative, per microliter

  142. Complete blood count after the double filtration plasmapheresis session : Monocytes

    Time frame: Day 0, Hour 1

    Quantitative, per microliter

  143. Complete blood count after the double filtration plasmapheresis session : Monocytes

    Time frame: Day 0, Hour 4

    Quantitative, per microliter

  144. Complete blood count after the double filtration plasmapheresis session : Monocytes

    Time frame: Day 1

    Quantitative, per microliter

  145. Complete blood count after the double filtration plasmapheresis session : Monocytes

    Time frame: Day 3

    Quantitative, per microliter

  146. Complete blood count before the double filtration plasmapheresis session : Eosinophils

    Time frame: Day 0, Hour 0

    Quantitative, per microliter

  147. Complete blood count after the double filtration plasmapheresis session : Eosinophils

    Time frame: Day 0, Hour 1

    Quantitative, per microliter

  148. Complete blood count after the double filtration plasmapheresis session : Eosinophils

    Time frame: Day 0, Hour 4

    Quantitative, per microliter

  149. Complete blood count after the double filtration plasmapheresis session : Eosinophils

    Time frame: Day 1

    Quantitative, per microliter

  150. Complete blood count after the double filtration plasmapheresis session : Eosinophils

    Time frame: Day 3

    Quantitative, per microliter

  151. Complete blood count before the double filtration plasmapheresis session : Basophils

    Time frame: Day 0, Hour 0

    Quantitative, per microliter

  152. Complete blood count after the double filtration plasmapheresis session : Basophils

    Time frame: Day 0, Hour 1

    Quantitative, per microliter

  153. Complete blood count after the double filtration plasmapheresis session : Basophils

    Time frame: Day 0, Hour 4

    Quantitative, per microliter

  154. Complete blood count after the double filtration plasmapheresis session : Basophils

    Time frame: Day 1

    Quantitative, per microliter

  155. Complete blood count after the double filtration plasmapheresis session : Basophils

    Time frame: Day 3

    Quantitative, per microliter

  156. Complete blood count before the double filtration plasmapheresis session : Hematocrit

    Time frame: Day 0, Hour 0

    Quantitative, %

  157. Complete blood count after the double filtration plasmapheresis session : Hematocrit

    Time frame: Day 0, Hour 1

    Quantitative, %

  158. Complete blood count after the double filtration plasmapheresis session : Hematocrit

    Time frame: Day 0, Hour 4

    Quantitative, %

  159. Complete blood count after the double filtration plasmapheresis session : Hematocrit

    Time frame: Day 1

    Quantitative, %

  160. Complete blood count after the double filtration plasmapheresis session : Hematocrit

    Time frame: Day 3

    Quantitative, %

  161. Complete blood count before the double filtration plasmapheresis session : Mean Corpuscular Volume

    Time frame: Day 0, Hour 0

    Quantitative, fL

  162. Complete blood count after the double filtration plasmapheresis session : Mean Corpuscular Volume

    Time frame: Day 0, Hour 1

    Quantitative, fL

  163. Complete blood count after the double filtration plasmapheresis session : Mean Corpuscular Volume

    Time frame: Day 0, Hour 4

    Quantitative, fL

  164. Complete blood count after the double filtration plasmapheresis session : Mean Corpuscular Volume

    Time frame: Day 1

    Quantitative, fL

  165. Complete blood count after the double filtration plasmapheresis session : Mean Corpuscular Volume

    Time frame: Day 3

    Quantitative, fL

  166. Complete blood count before the double filtration plasmapheresis session : Mean Corpuscular Hemoglobin

    Time frame: Day 0, Hour 0

    Quantitative, pg

  167. Complete blood count after the double filtration plasmapheresis session : Mean Corpuscular Hemoglobin

    Time frame: Day 0, Hour 1

    Quantitative, pg

  168. Complete blood count after the double filtration plasmapheresis session : Mean Corpuscular Hemoglobin

    Time frame: Day 0, Hour 4

    Quantitative, pg

  169. Complete blood count after the double filtration plasmapheresis session : Mean Corpuscular Hemoglobin

    Time frame: Day 1

    Quantitative, pg

  170. Complete blood count after the double filtration plasmapheresis session : Mean Corpuscular Hemoglobin

    Time frame: Day 3

    Quantitative, pg

  171. Complete blood count before the double filtration plasmapheresis session : Mean Corpuscular Hemoglobin Concentration

    Time frame: Day 0, Hour 0

    Quantitative, g/L

  172. Complete blood count after the double filtration plasmapheresis session : Mean Corpuscular Hemoglobin Concentration

    Time frame: Day 0, Hour 1

    Quantitative, g/L

  173. Complete blood count after the double filtration plasmapheresis session : Mean Corpuscular Hemoglobin Concentration

    Time frame: Day 0, Hour 4

    Quantitative, g/L

  174. Complete blood count after the double filtration plasmapheresis session : Mean Corpuscular Hemoglobin Concentration

    Time frame: Day 1

    Quantitative, g/L

  175. Complete blood count after the double filtration plasmapheresis session : Mean Corpuscular Hemoglobin Concentration

    Time frame: Day 3

    Quantitative, g/L

  176. Serum albumin before the double filtration plasmapheresis session.

    Time frame: Day 0, Hour 0

    Quantitative, g/L

  177. Serum albumin after the double filtration plasmapheresis session.

    Time frame: Day 0, Hour 1

    Quantitative, g/L

  178. Serum albumin after the double filtration plasmapheresis session.

    Time frame: Day 0, Hour 4

    Quantitative, g/L

  179. Serum albumin after the double filtration plasmapheresis session.

    Time frame: Day 1

    Quantitative, g/L

  180. Serum albumin after the double filtration plasmapheresis session.

    Time frame: Day 3

    Quantitative, g/L

  181. Prothrombin Time Test and International Normalized Ratio (PT/INR) before the double filtration plasmapheresis session.

    Time frame: Day 0, Hour 0

    In seconds

  182. Prothrombin Time Test and International Normalized Ratio (PT/INR) after the double filtration plasmapheresis session.

    Time frame: Day 0, Hour 1

    In seconds

  183. Prothrombin Time Test and International Normalized Ratio (PT/INR) after the double filtration plasmapheresis session.

    Time frame: Day 0, Hour 4

    In seconds

  184. Prothrombin Time Test and International Normalized Ratio (PT/INR) after the double filtration plasmapheresis session.

    Time frame: Day 1

    In seconds

  185. Prothrombin Time Test and International Normalized Ratio (PT/INR) after the double filtration plasmapheresis session.

    Time frame: Day 3

    In seconds

  186. Factors VIII, IX, XI and XII before the double filtration plasmapheresis session.

    Time frame: Day 0, Hour 0

    1-stage APTT-based Factor assay

  187. Factors VIII, IX, XI and XII after the double filtration plasmapheresis session.

    Time frame: Day 0, Hour 1

    1-stage APTT-based Factor assay

  188. Factors VIII, IX, XI and XII after the double filtration plasmapheresis session.

    Time frame: Day 0, Hour 4

    1-stage APTT-based Factor assay

  189. Factors VIII, IX, XI and XII after the double filtration plasmapheresis session.

    Time frame: Day 1

    1-stage APTT-based Factor assay

  190. Factors VIII, IX, XI and XII after the double filtration plasmapheresis session.

    Time frame: Day 3

    1-stage APTT-based Factor assay

  191. Factors X, V and II [Prothrombin] before the double filtration plasmapheresis session.

    Time frame: Day 0, Hour 0

    Prothrombin assay, in seconds

  192. Factors X, V and II [Prothrombin] after the double filtration plasmapheresis session.

    Time frame: Day 0, Hour 1

    Prothrombin assay, in seconds

  193. Factors X, V and II [Prothrombin] after the double filtration plasmapheresis session.

    Time frame: Day 0, Hour 4

    Prothrombin assay, in seconds

  194. Factors X, V and II [Prothrombin] after the double filtration plasmapheresis session.

    Time frame: Day 1

    Prothrombin assay, in seconds

  195. Factors X, V and II [Prothrombin] after the double filtration plasmapheresis session.

    Time frame: Day 3

    Prothrombin assay, in seconds

  196. D-dimers and circulating soluble fibrin monomers before the double filtration plasmapheresis session.

    Time frame: Day 0, Hour 0

    By enzyme-linked immunosorbent assay (ELISA) method

  197. D-dimers and circulating soluble fibrin monomers after the double filtration plasmapheresis session.

    Time frame: Day 0, Hour 1

    By enzyme-linked immunosorbent assay (ELISA) method

  198. D-dimers and circulating soluble fibrin monomers after the double filtration plasmapheresis session.

    Time frame: Day 0, Hour 4

    By enzyme-linked immunosorbent assay (ELISA) method

  199. D-dimers and circulating soluble fibrin monomers after the double filtration plasmapheresis session.

    Time frame: Day 1

    By enzyme-linked immunosorbent assay (ELISA) method

  200. D-dimers and circulating soluble fibrin monomers after the double filtration plasmapheresis session.

    Time frame: Day 3

    By enzyme-linked immunosorbent assay (ELISA) method

  201. Platelet function test before the double filtration plasmapheresis session.

    Time frame: Day 0, Hour 0

    ADP/collagen and adrenalin/collagen cartridges

  202. Platelet function test after the double filtration plasmapheresis session.

    Time frame: Day 0, Hour 1

    ADP/collagen and adrenalin/collagen cartridges

  203. Platelet function test after the double filtration plasmapheresis session.

    Time frame: Day 0, Hour 4

    ADP/collagen and adrenalin/collagen cartridges

  204. Platelet function test after the double filtration plasmapheresis session.

    Time frame: Day 1

    ADP/collagen and adrenalin/collagen cartridges

  205. Platelet function test after the double filtration plasmapheresis session.

    Time frame: Day 3

    ADP/collagen and adrenalin/collagen cartridges

  206. von Willebrand factor (vWF) activity - ristocetin cofactor test before the double filtration plasmapheresis session.

    Time frame: Day 0, Hour 0

    Binding to platelet membrane glycoprotein Ib

  207. von Willebrand factor (vWF) activity - ristocetin cofactor test after the double filtration plasmapheresis session.

    Time frame: Day 0, Hour 1

    Binding to platelet membrane glycoprotein Ib

  208. von Willebrand factor (vWF) activity - ristocetin cofactor test after the double filtration plasmapheresis session.

    Time frame: Day 0, Hour 4

    Binding to platelet membrane glycoprotein Ib

  209. von Willebrand factor (vWF) activity - ristocetin cofactor test after the double filtration plasmapheresis session.

    Time frame: Day 1

    Binding to platelet membrane glycoprotein Ib

  210. von Willebrand factor (vWF) activity - ristocetin cofactor test after the double filtration plasmapheresis session.

    Time frame: Day 3

    Binding to platelet membrane glycoprotein Ib

  211. Automated thrombin generation test on Génésia® before the plasmapheresis session with single plasma exchange (hemorrhagic exploration version)

    Time frame: Day 0, Hour 0

    Triggered by 1 pM tissue factor

  212. Automated thrombin generation test on Génésia® after the plasmapheresis session with single plasma exchange (hemorrhagic exploration version)

    Time frame: Day 0, Hour 1

    Triggered by 1 pM tissue factor

  213. Automated thrombin generation test on Génésia® after the plasmapheresis session with single plasma exchange (hemorrhagic exploration version)

    Time frame: Day 0, Hour 4

    Triggered by 1 pM tissue factor

  214. Automated thrombin generation test on Génésia® after the plasmapheresis session with single plasma exchange (hemorrhagic exploration version)

    Time frame: Day 1

    Triggered by 1 pM tissue factor

  215. Automated thrombin generation test on Génésia® after the plasmapheresis session with single plasma exchange (hemorrhagic exploration version)

    Time frame: Day 3

    Triggered by 1 pM tissue factor

  216. Automated thrombin generation test on Génésia® before the plasmapheresis session with single plasma exchange (thrombotic exploration version)

    Time frame: Day 0, Hour 0

    Triggered by 5 pM tissue factor with response to purified thrombomodulin

  217. Automated thrombin generation test on Génésia® after the plasmapheresis session with single plasma exchange (thrombotic exploration version)

    Time frame: Day 0, Hour 1

    Triggered by 5 pM tissue factor with response to purified thrombomodulin

  218. Automated thrombin generation test on Génésia® after the plasmapheresis session with single plasma exchange (thrombotic exploration version)

    Time frame: Day 0, Hour 4

    Triggered by 5 pM tissue factor with response to purified thrombomodulin

  219. Automated thrombin generation test on Génésia® after the plasmapheresis session with single plasma exchange (thrombotic exploration version)

    Time frame: Day 1

    Triggered by 5 pM tissue factor with response to purified thrombomodulin

  220. Automated thrombin generation test on Génésia® after the plasmapheresis session with single plasma exchange (thrombotic exploration version)

    Time frame: Day 3

    Triggered by 5 pM tissue factor with response to purified thrombomodulin

  221. Plasma Bank

    Time frame: Before Day 0, hour 0

    Storage of unused tube ends

  222. Plasma Bank

    Time frame: Day 0, hour1

    Storage of unused tube ends

  223. Plasma Bank

    Time frame: Day 0, hour 4

    Storage of unused tube ends

  224. Plasma Bank

    Time frame: Day 1

    Storage of unused tube ends

  225. Plasma Bank

    Time frame: Day 3

    Storage of unused tube ends

  226. Plasma Bank

    Time frame: After end of session Day 0, H0

    Storage of unused tube ends

Other outcomes

  1. Gender of patients

    Time frame: Day 0, Hour 0

    Recorded as Male, Female, Nonbinary

  2. Age of patients

    Time frame: Day 0, Hour 0

    Recorded in years

  3. Weight of patients

    Time frame: Day 0, Hour 0

    Recorded in kilos

  4. Height of patients

    Time frame: Day 0, Hour 0

    Recorded in centimeters

  5. Diagnostic history of patients

    Time frame: Day 0, Hour 0

    The patients' diagnostic history will be recorded

  6. Patient's apheresis protocol

    Time frame: Day 0, Hour 0

    The apheresis protocol used, and parameters related to plasmapheresis will be recorded

Study contacts

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

Anissa MEGZARI

CONTACT

[email protected]

+33466684236

Olivier MORANNE, Professor

CONTACT

[email protected]

+334.66.68.31.49

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study title

Description of Coagulation Disorders Secondary to Two Plasmapheresis Techniques (Double Filtration Plasmapheresis vs. PFS). Descriptive Pilot Study.

Acronym: APHERCOAG

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Aug 26, 2024
Registry last updated
Dec 20, 2024

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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