Actively Recruiting

Age: 18Years +
All Genders
NCT05855317

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

Led by Assistance Publique Hopitaux De Marseille · Updated on 2026-02-04

170

Participants Needed

1

Research Sites

208 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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, including:
    • Hypoxemia with PaO2/FiO2 ratio 64 300 on mechanical ventilation under PEEP 65 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
Not Eligible

You will not qualify if you...

  • Positive SARS-CoV-2 PCR in a pharyngeal or respiratory sample 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 intensive care
  • Patient undergoing extracorporeal veno-venous respiratory assistance (ECMO-VV) before admission
  • Patient undergoing extra-renal purification with systemic anticoagulation with heparin before admission
  • Minor patients, adult patients under tutorship or guardianship, patients deprived of liberty, pregnant or nursing women
  • Moribund patients with life expectancy less than 24 hours according to the investigating physician

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Service Médecine intensive et réanimation

Marseille, France, 13015

Actively Recruiting

Loading map...

Research Team

G

Giovanni Bousquet, MD

CONTACT

C

Christophe Guervilly, MD

CONTACT

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

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

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