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

NCT ID: NCT05855317

Last Updated: 2023-11-02

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 170 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-10-31
• Study Completion Date: 2025-12-31

Brief 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.

Conditions

Acute Respiratory Distress Syndrome

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with pulmonary embolism

The presence of pulmonary embolism is determined from a CT scan realized between Day 5 and Day 28.

Blood sample

Intervention Type: OTHER

Additional blood samples will be taken on a catheter, used for standard care.

Patients without pulmonary embolism

The absence of pulmonary embolism is determined from a CT scan realized between Day 5 and Day 28.

Blood sample

Intervention Type: OTHER

Additional blood samples will be taken on a catheter, used for standard care.

Interventions

Blood sample

Additional blood samples will be taken on a catheter, used for standard care.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

François Cremieux

Role: STUDY_DIRECTOR

AP-HM

Locations

Service Médecine intensive et réanimation

Marseille, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Giovanni Bousquet, MD

Role: CONTACT

giovanni.bousquet@ap-hm.fr

0491964252 ext. 33

Christophe Guervilly, MD

Role: CONTACT

christophe.guervilly@ap-hm.fr

0491965842 ext. 33

Facility Contacts

Giovanni Bousquet, MD

Role: primary

giovanni.bousquet@ap-hm.fr

0491964252 ext. 33

Other Identifiers

ID-RCB

Identifier Type: OTHER

Identifier Source: secondary_id

RCAPHM22_0440

Identifier Type: -

Identifier Source: org_study_id