Actively Recruiting
Association Between the Level of Extracellular Vesicle - Associated Tissue Factor and the Occurence of Pulmonary Embolism in Patients With Acute Respiratory Distress Syndrome
Led by Assistance Publique Hopitaux De Marseille · Updated on 2026-02-04
170
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying patients with Acute Respiratory Distress Syndrome (ARDS) to investigate whether the levels of a blood marker called EV-TF are associated with the occurrence of pulmonary embolism. The study will include 120 patients admitted to an intensive care unit over two years. Blood samples will be taken at the start to measure coagulation biomarkers, and patients will be monitored with CT scans to detect pulmonary embolism between days 5 and 28 after inclusion. Patients will receive standard care as per usual hospital practices. They will be divided into two groups based on CT scan results showing either the presence or absence of pulmonary embolism. The main analysis will focus on patients who had a CT scan between days 5 and 7, while a secondary analysis will include those scanned between days 8 and 28. Clinical data will be collected on days 1, 7, 28, and on the day of the CT scan if it occurs at another time. Participants will undergo blood tests to measure specific coagulation factors and biomarkers at inclusion. Researchers will collect clinical information regularly and compare EV-TF levels and other markers between patients with and without pulmonary embolism. The primary outcome is the difference in EV-TF levels at inclusion between these groups at day 7. Secondary outcomes include similar comparisons at day 28 and associations with patient prognosis and lung function. The study will continue to collect data until October 2027.
CONDITIONS
Brief Title
Association Between the Level of EV-TF and the Occurence of Pulmonary Embolism in Patients With ARDS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient 18 years of age or older
- Patient who has given non-opposition to participate, or a relative has given non-opposition
- Patient admitted to intensive care for less than 24 hours
- Patient diagnosed with ARDS according to Berlin criteria, including:
- Hypoxemia with PaO2/FiO2 ratio ≤ 300 on mechanical ventilation with PEEP ≥ 5 cmH2O
- Bilateral alveolar-interstitial opacities on chest imaging
- Exclusion of cardiogenic cause on echocardiography
- Acute or subacute onset within 7 days based on clinical-radiological profile
You will not qualify if you...
- Positive SARS-CoV-2 PCR before ICU admission
- Pathology affecting coagulation or endothelial function (e.g., hemophilia, von Willebrand disease)
- Receiving curative anticoagulant treatment before ICU admission
- Undergoing extracorporeal veno-venous respiratory assistance (ECMO-VV) before ICU admission
- Undergoing extra-renal purification with systemic heparin anticoagulation before ICU admission
- Minor patients, adults under tutorship or guardianship, patients deprived of liberty, pregnant or nursing women
- Moribund patients with life expectancy less than 24 hours as judged by physician
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - Up to 24 hours after ICU admission
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Between Day 5 and Day 28
Participants undergo diagnostic procedures to determine the presence or absence of pulmonary embolism using a CT scan performed between Day 5 and Day 28 after inclusion.
1 visit (in-person)
Duration - From inclusion up to Day 60
Participants have blood samples collected at multiple time points to measure extracellular vesicle-associated tissue factor and other coagulation markers to evaluate associations with pulmonary embolism and patient prognosis.
Blood samples collected at inclusion, Day 7, Day 28, and Day 60
Trial Site Locations
Total: 1 location
1
Service Médecine intensive et réanimation
Marseille, France, 13015
Actively Recruiting
Research Team
G
Giovanni Bousquet, MD
C
Christophe Guervilly, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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