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

NCT05855317 | Recruiting

• 2 other identifiers: RCAPHM22_0440ID-RCB
• Study Type: observational
• Target: 170
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Difference in EV-TF levels at inclusion between patients with and without pulmonary embolism at day 7 postinclusion

  EV-TF level is determined from a blood sample realized at inclusion and the presence of pulmonary embolism from a CT scan realized during the first week of patient care in intensive care unit.

  Day 7

Secondary Outcomes (51)

• Difference in EV-TF levels at inclusion between patients with and without pulmonary embolism at day 28 postinclusion

  Day 28

• Difference in EV-TF levels at inclusion between patients with and without venous thrombo-embolic disease at day 7 postinclusion

  Day 7

• Difference in EV-TF levels at inclusion between patients with and without venous thrombo-embolic disease at day 28 postinclusion

  Day 28

• Association between EV-TF levels and patient prognosis

  Day 60

• Association between EV-TF level and alveolar dead space at inclusion

  Day 1

Study Arms (2)

Patients with pulmonary embolism

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

Other: Blood sample

Patients without pulmonary embolism

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

Other: Blood sample

Interventions

Blood sample OTHER

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

Patients with pulmonary embolism; Patients without pulmonary embolism

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with ARDS admitted to the intensive care unit

You may qualify if:

• 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),
• Acute or subacute onset within 7 days based on the clinical-radiological profile.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Service Médecine intensive et réanimation

Marseille, 13015, France

RECRUITING

MeSH Terms

Conditions

Respiratory Distress Syndrome

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• François Cremieux

  AP-HM

  STUDY DIRECTOR

Central Study Contacts

Giovanni Bousquet, MD

CONTACT

0491964252; giovanni.bousquet@ap-hm.fr

Christophe Guervilly, MD

CONTACT

0491965842; christophe.guervilly@ap-hm.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2023
• First Posted: May 11, 2023
• Study Start: October 31, 2023
• Primary Completion (Estimated): October 30, 2027
• Study Completion (Estimated): October 30, 2027
• Last Updated: February 4, 2026

Record last verified: 2026-02

Locations

FR (1)