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NCT Number: NCT05855317

Association Between the Level of EV-TF and the Occurence of Pulmonary Embolism in Patients With ARDS

In this study, 120 patients with Acute Respiratory Distress Syndrome (ARDS) will be included on a two years-period in an intensive care unit (Assistance Publique des Hôpitaux de Marseille, France). Those patients will benefit from a blood test at inclusion in order to measure several coagulation biomarkers, including EV-TF. Subsequently, these patients will be treated according to the usual practices of the department, following recommendations. Patients who received an injected CT scan between Day 5 and Day 28 will be divided into two groups based on the presence or absence of a pulmonary embolism on imaging. The measured values of EV-TF levels and other studied biomarkers will be compared between these two groups in order to detect a possible association between them and the diagnosis of pulmonary embolism. It should be noted that patients receiving an injected CT-scan between Day 5 and Day 7 will be included in the main analysis while those receiving it between Day 8 and Day 28 will be included in the secondary analysis. Others will be excluded from any analysis. At the same time, several collections of clinical data will be carried out: on Day 1, Day 7, Day 28, and on the day of the CT scan if it is performed at another time.

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Key information

Conditions

Acute Respiratory Distress Syndrome Lung Diseases Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Service Médecine intensive et réanimation

Marseille, 13015, France

Location status: Recruiting

Location contact

Giovanni Bousquet, MD

CONTACT

[email protected]

0491964252 ext. 33

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient 18 years of age or older,
  • Patient who has given his/her non-opposition to participate in this study, or alternatively, patient for whom a relative has given his/her non-opposition to participate in this study,
  • Patient admitted to intensive care for less than 24 hours,
  • Patient with ARDS according to the Berlin criteria,
  • Hypoxemia with PaO2/FiO2 ratio ≤ 300 on mechanical ventilation under PEEP ≥ 5 cmH2O,
  • Bilateral alveolar-interstitial opacities on chest imaging (chest X-ray or CT),
  • Exclusion of a cardiogenic cause on echocardiography,
  • Acute or subacute onset within 7 days based on the clinical-radiological profile.

Exclusion criteria

  • Positive SARS-CoV-2 PCR in a pharyngeal or respiratory sample (cytobacteriological examination of sputum, bronchial aspiration or bronchoalveolar lavage) prior to admission to the intensive care unit,
  • Patient with a pathology affecting the coagulation process or endothelial function (hemophilia, von Willebrand disease, etc.),
  • Patient receiving curative anticoagulant treatment before admission to the intensive care unit,
  • Patient undergoing extracorporeal veno-venous respiratory assistance (ECMO-VV) before admission to the intensive care unit,
  • Patient undergoing extra-renal purification with systemic anticoagulation with heparin before admission to the intensive care unit,
  • Persons referred to in articles L. 1121-5 to L. 1121-8 of the Public Health Code (minor patients, adult patients under tutorship or guardianship, patients deprived of their liberty, pregnant or nursing women),
  • Moribund patients for whom the life expectancy is less than 24 hours according to the opinion of the investigating physician.

Treatment and study plan

blood sample

Other

Additional blood samples will be taken on a catheter, used for standard care.

Primary outcomes

  1. Difference in EV-TF levels at inclusion between patients with and without pulmonary embolism at day 7 postinclusion

    Time frame: Day 7

    EV-TF level is determined from a blood sample realized at inclusion and the presence of pulmonary embolism from a CT scan realized during the first week of patient care in intensive care unit.

Secondary outcomes

  1. Difference in EV-TF levels at inclusion between patients with and without pulmonary embolism at day 28 postinclusion

    Time frame: Day 28

    EV-TF level is determined from a blood sample realized at inclusion. The presence of pulmonary embolism is determined from a CT scan realized during the first 28 days of patient care in intensive care unit.

  2. Difference in EV-TF levels at inclusion between patients with and without venous thrombo-embolic disease at day 7 postinclusion

    Time frame: Day 7

    EV-TF level is determined from a blood sample realized at inclusion. The presence of venous thrombo-embolic disease is determined from an echo-doppler realized during the first week of patient care in intensive care unit.

  3. Difference in EV-TF levels at inclusion between patients with and without venous thrombo-embolic disease at day 28 postinclusion

    Time frame: Day 28

    EV-TF level is determined from a blood sample realized at inclusion. The presence of venous thrombo-embolic disease is determined from an echo-doppler realized during the first 28 days of patient care in intensive care unit.

  4. Association between EV-TF levels and patient prognosis

    Time frame: Day 60

    EV-TF level is determined from a blood sample realized at inclusion. Patient prognosis is based on the duration of intensive care unit stay, on the duration of hospital stay, and on death.

  5. Association between EV-TF level and alveolar dead space at inclusion

    Time frame: Day 1

    EV-TF level is determined from a blood sample realized at inclusion. Alveolar dead space is obtained by volumetric capnography at inclusion.

  6. Association between EV-TF level and alveolar dead space at day 7 postinclusion

    Time frame: Day 7

    EV-TF level is determined from a blood sample realized at inclusion. Alveolar dead space is obtained by volumetric capnography at day 7 postinclusion.

  7. Association between EV-TF level and alveolar dead space at day 28 postinclusion

    Time frame: Day 28

    EV-TF level is determined from a blood sample realized at inclusion. Alveolar dead space is obtained by volumetric capnography at day 28 postinclusion.

  8. Association between EV-TF level and alveolar dead space at thoracic CT scan day

    Time frame: Between day 5 and day 28

    EV-TF level is determined from a blood sample realized at inclusion. Alveolar dead space is obtained by volumetric capnography at day of CT-scan.

  9. Optimal threshold value of EV-TF associated with the occurrence of pulmonary embolism.

    Time frame: Day 28

    EV-TF level is determined from a blood sample realized at inclusion. Occurrence of pulmonary embolism is determined from a CT scan realized during the first 28 days of patient care in intensive care unit.

  10. Optimal threshold value of EV-TF associated with the occurrence of venous thrombo-embolic disease.

    Time frame: Day 28

    EV-TF level is determined from a blood sample realized at inclusion. Occurrence of venous thrombo-embolic disease pulmonary embolism is determined from an echo-doppler realized during the first 28 days of patient care in intensive care unit.

  11. Optimal threshold value of EV-TF associated with the occurrence of death

    Time frame: Day 60

    EV-TF level is determined from a blood sample realized at inclusion. Occurrence of death is measured during the 2 months of follow up (or when the patient is discharged from hospital, if earlier).

  12. Predictive value of Willebrand antigen at inclusion on the occurrence of pulmonary embolism at day 7.

    Time frame: Day 7

    This biomarker is quantified from the blood sample collected at inclusion. The presence of pulmonary embolism from a CT scan realized during the first week of patient care in intensive care unit.

  13. Predictive value of ADAMTS13 activity at inclusion on the occurrence of pulmonary embolism at day 7.

    Time frame: Day 7

    This biomarker is quantified from the blood sample collected at inclusion. The presence of pulmonary embolism from a CT scan realized during the first week of patient care in intensive care unit.

  14. Predictive value of circulating levels of antithrombin (coagulation inhibitor) at inclusion on the occurrence of pulmonary embolism at day 7.

    Time frame: Day 7

    This biomarker is quantified from the blood sample collected at inclusion. The presence of pulmonary embolism from a CT scan realized during the first week of patient care in intensive care unit.

  15. Predictive value of circulating levels of protein C (coagulation inhibitor) at inclusion on the occurrence of pulmonary embolism at day 7.

    Time frame: Day 7

    This biomarker is quantified from the blood sample collected at inclusion. The presence of pulmonary embolism from a CT scan realized during the first week of patient care in intensive care unit.

  16. Predictive value of circulating levels of protein S (coagulation inhibitor) at inclusion on the occurrence of pulmonary embolism at day 7.

    Time frame: Day 7

    This biomarker is quantified from the blood sample collected at inclusion. The presence of pulmonary embolism from a CT scan realized during the first week of patient care in intensive care unit.

  17. Predictive value of D-dimers (circulating fibrinolytic potential) at inclusion on the occurrence of pulmonary embolism at day 7.

    Time frame: Day 7

    This biomarker is quantified from the blood sample collected at inclusion. The presence of pulmonary embolism from a CT scan realized during the first week of patient care in intensive care unit.

  18. Predictive value of fibrin monomers (circulating fibrinolytic potential) at inclusion on the occurrence of pulmonary embolism at day 7.

    Time frame: Day 7

    This biomarker is quantified from the blood sample collected at inclusion. The presence of pulmonary embolism from a CT scan realized during the first week of patient care in intensive care unit.

  19. Predictive value of circulating PAI-1 (circulating fibrinolytic potential) at inclusion on the occurrence of pulmonary embolism at day 7.

    Time frame: Day 7

    This biomarker is quantified from the blood sample collected at inclusion. The presence of pulmonary embolism from a CT scan realized during the first week of patient care in intensive care unit.

  20. Predictive value of Willebrand antigen at inclusion on the occurrence of pulmonary embolism at day 28.

    Time frame: Day 28

    This biomarker is quantified from the blood sample collected at inclusion. The presence of pulmonary embolism is determined from a CT scan realized during the first 28 days of patient care in intensive care unit.

  21. Predictive value of ADAMTS13 activity at inclusion on the occurrence of pulmonary embolism at day 28.

    Time frame: Day 28

    This biomarker is quantified from the blood sample collected at inclusion. The presence of pulmonary embolism is determined from a CT scan realized during the first 28 days of patient care in intensive care unit.

  22. Predictive value of circulating levels of antithrombin (coagulation inhibitor) at inclusion on the occurrence of pulmonary embolism at day 28.

    Time frame: Day 28

    This biomarker is quantified from the blood sample collected at inclusion. The presence of pulmonary embolism is determined from a CT scan realized during the first 28 days of patient care in intensive care unit.

  23. Predictive value of circulating levels of protein C (coagulation inhibitor) at inclusion on the occurrence of pulmonary embolism at day 28.

    Time frame: Day 28

    This biomarker is quantified from the blood sample collected at inclusion. The presence of pulmonary embolism is determined from a CT scan realized during the first 28 days of patient care in intensive care unit.

  24. Predictive value of circulating levels of protein S (coagulation inhibitor) at inclusion on the occurrence of pulmonary embolism at day 28.

    Time frame: Day 28

    This biomarker is quantified from the blood sample collected at inclusion. The presence of pulmonary embolism is determined from a CT scan realized during the first 28 days of patient care in intensive care unit.

  25. Predictive value of D-dimers (circulating fibrinolytic potential) at inclusion on the occurrence of pulmonary embolism at day 28.

    Time frame: Day 28

    This biomarker is quantified from the blood sample collected at inclusion. The presence of pulmonary embolism is determined from a CT scan realized during the first 28 days of patient care in intensive care unit.

  26. Predictive value of fibrin monomers (circulating fibrinolytic potential) at inclusion on the occurrence of pulmonary embolism at day 28.

    Time frame: Day 28

    This biomarker is quantified from the blood sample collected at inclusion. The presence of pulmonary embolism is determined from a CT scan realized during the first 28 days of patient care in intensive care unit.

  27. Predictive value of circulating PAI-1 (circulating fibrinolytic potential) at inclusion on the occurrence of pulmonary embolism at day 28.

    Time frame: Day 28

    This biomarker is quantified from the blood sample collected at inclusion. The presence of pulmonary embolism is determined from a CT scan realized during the first 28 days of patient care in intensive care unit.

  28. Predictive value of Willebrand antigen at inclusion on the occurrence of venous thrombo-embolic disease at day 7.

    Time frame: Day 7

    This biomarker is quantified from the blood sample collected at inclusion. The presence of venous thrombo-embolic disease is determined from an echo-doppler realized during the first week of patient care in intensive care unit.

  29. Predictive value of ADAMTS13 activity at inclusion on the occurrence of venous thrombo-embolic disease at day 7.

    Time frame: Day 7

    This biomarker is quantified from the blood sample collected at inclusion. The presence of venous thrombo-embolic disease is determined from an echo-doppler realized during the first week of patient care in intensive care unit.

  30. Predictive value of circulating levels of antithrombin (coagulation inhibitor) at inclusion on the occurrence of venous thrombo-embolic disease at day 7.

    Time frame: Day 7

    This biomarker is quantified from the blood sample collected at inclusion. The presence of venous thrombo-embolic disease is determined from an echo-doppler realized during the first week of patient care in intensive care unit.

  31. Predictive value of circulating levels of protein C (coagulation inhibitor) at inclusion on the occurrence of venous thrombo-embolic disease at day 7.

    Time frame: Day 7

    This biomarker is quantified from the blood sample collected at inclusion. The presence of venous thrombo-embolic disease is determined from an echo-doppler realized during the first week of patient care in intensive care unit.

  32. Predictive value of circulating levels protein S (coagulation inhibitor) at inclusion on the occurrence of venous thrombo-embolic disease at day 7.

    Time frame: Day 7

    This biomarker is quantified from the blood sample collected at inclusion. The presence of venous thrombo-embolic disease is determined from an echo-doppler realized during the first week of patient care in intensive care unit.

  33. Predictive value of D-dimers (circulating fibrinolytic potential) at inclusion on the occurrence of venous thrombo-embolic disease at day 7.

    Time frame: Day 7

    This biomarker is quantified from the blood sample collected at inclusion. The presence of venous thrombo-embolic disease is determined from an echo-doppler realized during the first week of patient care in intensive care unit.

  34. Predictive value of fibrin monomers (circulating fibrinolytic potential) at inclusion on the occurrence of venous thrombo-embolic disease at day 7.

    Time frame: Day 7

    This biomarker is quantified from the blood sample collected at inclusion. The presence of venous thrombo-embolic disease is determined from an echo-doppler realized during the first week of patient care in intensive care unit.

  35. Predictive value of circulating PAI-1 (circulating fibrinolytic potential) at inclusion on the occurrence of venous thrombo-embolic disease at day 7.

    Time frame: Day 7

    This biomarker is quantified from the blood sample collected at inclusion. The presence of venous thrombo-embolic disease is determined from an echo-doppler realized during the first week of patient care in intensive care unit.

  36. Predictive value of Willebrand antigen at inclusion on the occurrence of venous thrombo-embolic disease at day 28.

    Time frame: Day 28

    This biomarker is quantified from the blood sample collected at inclusion. The presence of venous thrombo-embolic disease is determined from an echo-doppler realized during the first 28 days of patient care in intensive care unit.

  37. Predictive value of ADAMTS13 activity at inclusion on the occurrence of venous thrombo-embolic disease at day 28.

    Time frame: Day 28

    This biomarker is quantified from the blood sample collected at inclusion. The presence of venous thrombo-embolic disease is determined from an echo-doppler realized during the first 28 days of patient care in intensive care unit.

  38. Predictive value of circulating levels of antithrombin (coagulation inhibitor) at inclusion on the occurrence of venous thrombo-embolic disease at day 28.

    Time frame: Day 28

    This biomarker is quantified from the blood sample collected at inclusion. The presence of venous thrombo-embolic disease is determined from an echo-doppler realized during the first 28 days of patient care in intensive care unit.

  39. Predictive value of circulating levels of protein C (coagulation inhibitor) at inclusion on the occurrence of venous thrombo-embolic disease at day 28.

    Time frame: Day 28

    This biomarker is quantified from the blood sample collected at inclusion. The presence of venous thrombo-embolic disease is determined from an echo-doppler realized during the first 28 days of patient care in intensive care unit.

  40. Predictive value of circulating levels of protein S (coagulation inhibitor) at inclusion on the occurrence of venous thrombo-embolic disease at day 28.

    Time frame: Day 28

    This biomarker is quantified from the blood sample collected at inclusion. The presence of venous thrombo-embolic disease is determined from an echo-doppler realized during the first 28 days of patient care in intensive care unit.

  41. Predictive value of D-dimers (circulating fibrinolytic potential) at inclusion on the occurrence of venous thrombo-embolic disease at day 28.

    Time frame: Day 28

    This biomarker is quantified from the blood sample collected at inclusion. The presence of venous thrombo-embolic disease is determined from an echo-doppler realized during the first 28 days of patient care in intensive care unit.

  42. Predictive value of fibrin monomers (circulating fibrinolytic potential) at inclusion on the occurrence of venous thrombo-embolic disease at day 28.

    Time frame: Day 28

    This biomarker is quantified from the blood sample collected at inclusion. The presence of venous thrombo-embolic disease is determined from an echo-doppler realized during the first 28 days of patient care in intensive care unit.

  43. Predictive value of circulating PAI-1 (circulating fibrinolytic potential) at inclusion on the occurrence of venous thrombo-embolic disease at day 28.

    Time frame: Day 28

    This biomarker is quantified from the blood sample collected at inclusion. The presence of venous thrombo-embolic disease is determined from an echo-doppler realized during the first 28 days of patient care in intensive care unit.

  44. Predictive value of Willebrand antigen at inclusion on the patients' death.

    Time frame: Day 60

    This biomarker is quantified from the blood sample collected at inclusion. Occurrence of death is measured during the 2 months of follow up (or when the patient is discharged from hospital, if earlier).

  45. Predictive value of ADAMTS13 activity at inclusion on the patients' death.

    Time frame: Day 60

    This biomarker is quantified from the blood sample collected at inclusion. Occurrence of death is measured during the 2 months of follow up (or when the patient is discharged from hospital, if earlier).

  46. Predictive value of of circulating levels of antithrombin (coagulation inhibitor) at inclusion on the patients' death.

    Time frame: Day 60

    This biomarker is quantified from the blood sample collected at inclusion. Occurrence of death is measured during the 2 months of follow up (or when the patient is discharged from hospital, if earlier).

  47. Predictive value of of circulating levels of protein C (coagulation inhibitor) at inclusion on the patients' death.

    Time frame: Day 60

    This biomarker is quantified from the blood sample collected at inclusion. Occurrence of death is measured during the 2 months of follow up (or when the patient is discharged from hospital, if earlier).

  48. Predictive value of of circulating levels of protein S (coagulation inhibitor) at inclusion on the patients' death.

    Time frame: Day 60

    This biomarker is quantified from the blood sample collected at inclusion. Occurrence of death is measured during the 2 months of follow up (or when the patient is discharged from hospital, if earlier).

  49. Predictive value of D-dimers (circulating fibrinolytic potential) at inclusion on the patients' death.

    Time frame: Day 60

    This biomarker is quantified from the blood sample collected at inclusion. Occurrence of death is measured during the 2 months of follow up (or when the patient is discharged from hospital, if earlier).

  50. Predictive value of fibrin monomers (circulating fibrinolytic potential) at inclusion on the patients' death.

    Time frame: Day 60

    This biomarker is quantified from the blood sample collected at inclusion. Occurrence of death is measured during the 2 months of follow up (or when the patient is discharged from hospital, if earlier).

  51. Predictive value of circulating PAI-1 (circulating fibrinolytic potential) at inclusion on the patients' death.

    Time frame: Day 60

    This biomarker is quantified from the blood sample collected at inclusion. Occurrence of death is measured during the 2 months of follow up (or when the patient is discharged from hospital, if earlier).

Study contacts

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

Christophe Guervilly, MD

CONTACT

[email protected]

0491965842 ext. 33

Giovanni Bousquet, MD

CONTACT

[email protected]

0491964252 ext. 33

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Official study title

Association Between the Level of Extracellular Vesicle - Associated Tissue Factor and the Occurence of Pulmonary Embolism in Patients With Acute Respiratory Distress Syndrome

Acronym: THROMBO-EVTF

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
May 11, 2023
Registry last updated
Feb 4, 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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