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

Official title

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

Overview

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.

Interventions

• Other Blood sample
  Additional blood samples will be taken on a catheter, used for standard care.

Primary outcome measures

• Difference in EV-TF levels at inclusion between patients with and without pulmonary embolism at day 7 postinclusion [Time frame: Day 7]

Secondary outcome measures (12)

• Difference in EV-TF levels at inclusion between patients with and without pulmonary embolism at day 28 postinclusion [Time frame: Day 28]
• Difference in EV-TF levels at inclusion between patients with and without venous thrombo-embolic disease at day 7 postinclusion [Time frame: Day 7]
• Difference in EV-TF levels at inclusion between patients with and without venous thrombo-embolic disease at day 28 postinclusion [Time frame: Day 28]
• Association between EV-TF levels and patient prognosis [Time frame: Day 60]
• Association between EV-TF level and alveolar dead space at inclusion [Time frame: Day 1]
• Association between EV-TF level and alveolar dead space at day 7 postinclusion [Time frame: Day 7]
• Association between EV-TF level and alveolar dead space at day 28 postinclusion [Time frame: Day 28]
• Association between EV-TF level and alveolar dead space at thoracic CT scan day [Time frame: Between day 5 and day 28]
• Optimal threshold value of EV-TF associated with the occurrence of pulmonary embolism. [Time frame: Day 28]
• Optimal threshold value of EV-TF associated with the occurrence of venous thrombo-embolic disease. [Time frame: Day 28]
• Optimal threshold value of EV-TF associated with the occurrence of death [Time frame: Day 60]
• Predictive value of Willebrand antigen at inclusion on the occurrence of pulmonary embolism at day 7. [Time frame: Day 7]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

France · 1 center

• Service Médecine intensive et réanimation — Marseille

Identifiers

NCT: NCT05855317 · RCAPHM22_0440 · ID-RCB

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗