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

Association Between the Level of Extracellular Vesicle - Associated Tissue Factor and the Occurence of Pulmonary Embolism in Patients With Acute Respiratory Distress Syndrome

This study is testing if certain blood markers can help understand the risk of pulmonary embolism in patients with Acute Respiratory Distress Syndrome (ARDS) in the ICU.

Quick facts

• Study type: Observational
• Enrollment: 170 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Assistance Publique Hopitaux De Marseille (Academic / other)
• Locations: 1 site (Marseille)
• Trial ID: NCT05855317 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who are admitted to intensive care with ARDS as defined by specific clinical criteria.

Not a fit: Patients with a positive SARS-CoV-2 PCR prior to ICU admission or those with coagulation disorders will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the understanding of biomarkers in predicting pulmonary embolism in ARDS patients, potentially leading to improved patient management.

How similar studies have performed: While the specific association of EV-TF with pulmonary embolism in ARDS is novel, similar studies have explored biomarkers in critical care settings with varying degrees of success.

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.

Where this trial is running

Marseille

• Service Médecine intensive et réanimation — Marseille, France (Recruiting)

Study contacts

• Study coordinator: Giovanni Bousquet, MD

Conditions Acute Respiratory Distress Syndrome