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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
Service Médecine intensive et réanimation
RECRUITING
Marseille
Contact Information
Primary
Giovanni Bousquet, MD
giovanni.bousquet@ap-hm.fr
0491964252
Backup
Christophe Guervilly, MD
christophe.guervilly@ap-hm.fr
0491965842
Time Frame
Start Date: 2023-10-31
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 170
Treatments
Patients with pulmonary embolism
The presence of pulmonary embolism is determined from a CT scan realized between Day 5 and Day 28.
Patients without pulmonary embolism
The absence of pulmonary embolism is determined from a CT scan realized between Day 5 and Day 28.
Sponsors
Leads: Assistance Publique Hopitaux De Marseille

This content was sourced from clinicaltrials.gov