Examining the link between blood markers and pulmonary embolism in ARDS patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study will include 120 patients diagnosed with Acute Respiratory Distress Syndrome (ARDS) in an intensive care unit over a two-year period. Participants will undergo a blood test to measure coagulation biomarkers, including EV-TF, upon inclusion. Following standard treatment protocols, patients who receive an injected CT scan between Days 5 and 28 will be categorized based on the presence or absence of pulmonary embolism. The study aims to compare EV-TF levels and other biomarkers between these groups to identify any potential associations with pulmonary embolism.

Why it matters

Who can join: the full rules

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.

Where it's running

• Service Médecine intensive et réanimation
  Marseille, France Recruiting

Study contacts

• Study coordinator: Giovanni Bousquet, MD
• Email: giovanni.bousquet@ap-hm.fr
• Phone: 0491964252

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.