Clinical trial NCT05855317: Association Between the Level of EV-TF and the Occurence of Pulmonary Embolism in Patients With ARDS
Official title: Association Between the Level of Extracellular Vesicle - Associated Tissue Factor and the Occurence of Pulmonary Embolism in Patients With Acute Respiratory Distress Syndrome
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Respiratory Distress Syndrome
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2023-05-11
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with ARDS admitted to the intensive care unit

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Difference in EV-TF levels at inclusion between patients with and without pulmonary embolism at day 7 postinclusion
timeFrame: Day 7
Secondary outcomes:
measure: Difference in EV-TF levels at inclusion between patients with and without pulmonary embolism at day 28 postinclusion
timeFrame: Day 28
measure: Difference in EV-TF levels at inclusion between patients with and without venous thrombo-embolic disease at day 7 postinclusion
timeFrame: Day 7
measure: Difference in EV-TF levels at inclusion between patients with and without venous thrombo-embolic disease at day 28 postinclusion
timeFrame: Day 28
measure: Association between EV-TF levels and patient prognosis
timeFrame: Day 60
measure: Association between EV-TF level and alveolar dead space at inclusion
timeFrame: Day 1
measure: Association between EV-TF level and alveolar dead space at day 7 postinclusion
timeFrame: Day 7
measure: Association between EV-TF level and alveolar dead space at day 28 postinclusion
timeFrame: Day 28
measure: Association between EV-TF level and alveolar dead space at thoracic CT scan day
timeFrame: Between day 5 and day 28
measure: Optimal threshold value of EV-TF associated with the occurrence of pulmonary embolism.
timeFrame: Day 28
measure: Optimal threshold value of EV-TF associated with the occurrence of venous thrombo-embolic disease.
timeFrame: Day 28
measure: Optimal threshold value of EV-TF associated with the occurrence of death
timeFrame: Day 60
measure: Predictive value of Willebrand antigen at inclusion on the occurrence of pulmonary embolism at day 7.
timeFrame: Day 7
measure: Predictive value of ADAMTS13 activity at inclusion on the occurrence of pulmonary embolism at day 7.
timeFrame: Day 7
measure: Predictive value of circulating levels of antithrombin (coagulation inhibitor) at inclusion on the occurrence of pulmonary embolism at day 7.
timeFrame: Day 7
measure: Predictive value of circulating levels of protein C (coagulation inhibitor) at inclusion on the occurrence of pulmonary embolism at day 7.
timeFrame: Day 7
measure: Predictive value of circulating levels of protein S (coagulation inhibitor) at inclusion on the occurrence of pulmonary embolism at day 7.
timeFrame: Day 7
measure: Predictive value of D-dimers (circulating fibrinolytic potential) at inclusion on the occurrence of pulmonary embolism at day 7.
timeFrame: Day 7
measure: Predictive value of fibrin monomers (circulating fibrinolytic potential) at inclusion on the occurrence of pulmonary embolism at day 7.
timeFrame: Day 7
measure: Predictive value of circulating PAI-1 (circulating fibrinolytic potential) at inclusion on the occurrence of pulmonary embolism at day 7.
timeFrame: Day 7
measure: Predictive value of Willebrand antigen at inclusion on the occurrence of pulmonary embolism at day 28.
timeFrame: Day 28
measure: Predictive value of ADAMTS13 activity at inclusion on the occurrence of pulmonary embolism at day 28.
timeFrame: Day 28
measure: Predictive value of circulating levels of antithrombin (coagulation inhibitor) at inclusion on the occurrence of pulmonary embolism at day 28.
timeFrame: Day 28
measure: Predictive value of circulating levels of protein C (coagulation inhibitor) at inclusion on the occurrence of pulmonary embolism at day 28.
timeFrame: Day 28
measure: Predictive value of circulating levels of protein S (coagulation inhibitor) at inclusion on the occurrence of pulmonary embolism at day 28.
timeFrame: Day 28
measure: Predictive value of D-dimers (circulating fibrinolytic potential) at inclusion on the occurrence of pulmonary embolism at day 28.
timeFrame: Day 28
measure: Predictive value of fibrin monomers (circulating fibrinolytic potential) at inclusion on the occurrence of pulmonary embolism at day 28.
timeFrame: Day 28
measure: Predictive value of circulating PAI-1 (circulating fibrinolytic potential) at inclusion on the occurrence of pulmonary embolism at day 28.
timeFrame: Day 28
measure: Predictive value of Willebrand antigen at inclusion on the occurrence of venous thrombo-embolic disease at day 7.
timeFrame: Day 7
measure: Predictive value of ADAMTS13 activity at inclusion on the occurrence of venous thrombo-embolic disease at day 7.
timeFrame: Day 7
measure: Predictive value of circulating levels of antithrombin (coagulation inhibitor) at inclusion on the occurrence of venous thrombo-embolic disease at day 7.
timeFrame: Day 7
measure: Predictive value of circulating levels of protein C (coagulation inhibitor) at inclusion on the occurrence of venous thrombo-embolic disease at day 7.
timeFrame: Day 7
measure: Predictive value of circulating levels protein S (coagulation inhibitor) at inclusion on the occurrence of venous thrombo-embolic disease at day 7.
timeFrame: Day 7
measure: Predictive value of D-dimers (circulating fibrinolytic potential) at inclusion on the occurrence of venous thrombo-embolic disease at day 7.
timeFrame: Day 7
measure: Predictive value of fibrin monomers (circulating fibrinolytic potential) at inclusion on the occurrence of venous thrombo-embolic disease at day 7.
timeFrame: Day 7
measure: Predictive value of circulating PAI-1 (circulating fibrinolytic potential) at inclusion on the occurrence of venous thrombo-embolic disease at day 7.
timeFrame: Day 7
measure: Predictive value of Willebrand antigen at inclusion on the occurrence of venous thrombo-embolic disease at day 28.
timeFrame: Day 28
measure: Predictive value of ADAMTS13 activity at inclusion on the occurrence of venous thrombo-embolic disease at day 28.
timeFrame: Day 28
measure: Predictive value of circulating levels of antithrombin (coagulation inhibitor) at inclusion on the occurrence of venous thrombo-embolic disease at day 28.
timeFrame: Day 28
measure: Predictive value of circulating levels of protein C (coagulation inhibitor) at inclusion on the occurrence of venous thrombo-embolic disease at day 28.
timeFrame: Day 28
measure: Predictive value of circulating levels of protein S (coagulation inhibitor) at inclusion on the occurrence of venous thrombo-embolic disease at day 28.
timeFrame: Day 28
measure: Predictive value of D-dimers (circulating fibrinolytic potential) at inclusion on the occurrence of venous thrombo-embolic disease at day 28.
timeFrame: Day 28
measure: Predictive value of fibrin monomers (circulating fibrinolytic potential) at inclusion on the occurrence of venous thrombo-embolic disease at day 28.
timeFrame: Day 28
measure: Predictive value of circulating PAI-1 (circulating fibrinolytic potential) at inclusion on the occurrence of venous thrombo-embolic disease at day 28.
timeFrame: Day 28
measure: Predictive value of Willebrand antigen at inclusion on the patients' death.
timeFrame: Day 60
measure: Predictive value of ADAMTS13 activity at inclusion on the patients' death.
timeFrame: Day 60
measure: Predictive value of of circulating levels of antithrombin (coagulation inhibitor) at inclusion on the patients' death.
timeFrame: Day 60
measure: Predictive value of of circulating levels of protein C (coagulation inhibitor) at inclusion on the patients' death.
timeFrame: Day 60
measure: Predictive value of of circulating levels of protein S (coagulation inhibitor) at inclusion on the patients' death.
timeFrame: Day 60
measure: Predictive value of D-dimers (circulating fibrinolytic potential) at inclusion on the patients' death.
timeFrame: Day 60
measure: Predictive value of fibrin monomers (circulating fibrinolytic potential) at inclusion on the patients' death.
timeFrame: Day 60
measure: Predictive value of circulating PAI-1 (circulating fibrinolytic potential) at inclusion on the patients' death.
timeFrame: Day 60
Other outcomes:
Locations:
city: Marseille
country: France
facility: Service Médecine intensive et réanimation
Study officials:
affiliation: AP-HM
name: François Cremieux
role: STUDY_DIRECTOR
References: