NCT05855317 Association Between the Level of EV-TF and the Occurence of Pulmonary Embolism in Patients With ARDS

Eligibility & Interventions

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What to Expect as a Participant

This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.

This trial targets 170 participants in total. It began in 2023-10-31 with a primary completion date of 2027-10-30.

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.

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