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

NCT05855317 · tracked via the Priya Life Science France tracker

Sponsor

Assistance Publique Hopitaux De Marseille

Phase

Observational

Started

2023-10-31

Last updated

2026-02-04

Condition(s) studied

Acute Respiratory Distress Syndrome

Investigational drug(s) / intervention(s)

Blood sample

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

Study 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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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 outcome measure(s)

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

Trial sites (1)

Facility	City	Region	Status
Service Médecine intensive et réanimation	Marseille	France	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05855317 on ClinicalTrials.gov ↗ ← All trials in France