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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssistance Publique Hopitaux De Marseille

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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,

Disqualifiers

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,

Trial population

Patients with ARDS admitted to the intensive care unit

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Blood sample

    Other intervention

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

Treatment groups

170 Participants
are divided into 2 treatment groups
Group A: Patients with pulmonary embolism1 intervention
Group B: Patients without pulmonary embolism1 intervention

Trial outcomes

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.

Time frame
Day 7

Secondary outcomes

1

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

EV-TF level is determined from a blood sample realized at inclusion. The presence of pulmonary embolism is determined from a CT scan realized during the first 28 days of patient care in intensive care unit.

Time frame
Day 28
2

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

EV-TF level is determined from a blood sample realized at inclusion. The presence of venous thrombo-embolic disease is determined from an echo-doppler realized during the first week of patient care in intensive care unit.

Time frame
Day 7
3

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

EV-TF level is determined from a blood sample realized at inclusion. The presence of venous thrombo-embolic disease is determined from an echo-doppler realized during the first 28 days of patient care in intensive care unit.

Time frame
Day 28
4

Association between EV-TF levels and patient prognosis

EV-TF level is determined from a blood sample realized at inclusion. Patient prognosis is based on the duration of intensive care unit stay, on the duration of hospital stay, and on death.

Time frame
Day 60

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.