Acute Respiratory Distress SyndromeTHROMBO-EVTFNCT05855317
Association Between the Level of EV-TF and the Occurence of Pulmonary Embolism in Patients With ARDS
An observational study of Acute Respiratory Distress Syndrome, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome
- What is being tested?
- Blood sample
- How many people
- 170 participants
- Where
- 1 siteFrance
- Study dates
- 31 Oct 2023to 30 Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with ARDS admitted to the intensive care unit
Who may be able to join
- 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),
Who cannot join
- Acute or subacute onset within 7 days based on the clinical-radiological profile.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Service Médecine intensive et réanimation
Marseille, 13015
Giovanni Bousquet, MD, 0491964252 ext. 33, giovanni.bousquet@ap-hm.fr
About this study
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
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
- Being tested
- Blood sample
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleOther
Additional blood samples will be taken on a catheter, used for standard care.
| Study group | Role | What they receive |
|---|---|---|
| Patients with pulmonary embolism | The presence of pulmonary embolism is determined from a CT scan realized between Day 5 and Day 28. Receives: 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. Receives: Other: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 7
Secondary outcomes (51)
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.
Measured: Day 28
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.
Measured: Day 7
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.
Measured: Day 28
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.
Measured: Day 60
Association between EV-TF level and alveolar dead space at inclusion
EV-TF level is determined from a blood sample realized at inclusion. Alveolar dead space is obtained by volumetric capnography at inclusion.
Measured: Day 1
Association between EV-TF level and alveolar dead space at day 7 postinclusion
EV-TF level is determined from a blood sample realized at inclusion. Alveolar dead space is obtained by volumetric capnography at day 7 postinclusion.
Measured: Day 7
Association between EV-TF level and alveolar dead space at day 28 postinclusion
EV-TF level is determined from a blood sample realized at inclusion. Alveolar dead space is obtained by volumetric capnography at day 28 postinclusion.
Measured: Day 28
Association between EV-TF level and alveolar dead space at thoracic CT scan day
EV-TF level is determined from a blood sample realized at inclusion. Alveolar dead space is obtained by volumetric capnography at day of CT-scan.
Measured: Between day 5 and day 28
Optimal threshold value of EV-TF associated with the occurrence of pulmonary embolism.
EV-TF level is determined from a blood sample realized at inclusion. Occurrence of pulmonary embolism is determined from a CT scan realized during the first 28 days of patient care in intensive care unit.
Measured: Day 28
Optimal threshold value of EV-TF associated with the occurrence of venous thrombo-embolic disease.
EV-TF level is determined from a blood sample realized at inclusion. Occurrence of venous thrombo-embolic disease pulmonary embolism is determined from an echo-doppler realized during the first 28 days of patient care in intensive care unit.
Measured: Day 28
Optimal threshold value of EV-TF associated with the occurrence of death
EV-TF level is determined from a blood sample realized at inclusion. Occurrence of death is measured during the 2 months of follow up (or when the patient is discharged from hospital, if earlier).
Measured: Day 60
Predictive value of Willebrand antigen at inclusion on the occurrence of pulmonary embolism at day 7.
This biomarker is quantified from the blood sample collected at inclusion. The presence of pulmonary embolism from a CT scan realized during the first week of patient care in intensive care unit.
Measured: Day 7
Predictive value of ADAMTS13 activity at inclusion on the occurrence of pulmonary embolism at day 7.
This biomarker is quantified from the blood sample collected at inclusion. The presence of pulmonary embolism from a CT scan realized during the first week of patient care in intensive care unit.
Measured: Day 7
Predictive value of circulating levels of antithrombin (coagulation inhibitor) at inclusion on the occurrence of pulmonary embolism at day 7.
This biomarker is quantified from the blood sample collected at inclusion. The presence of pulmonary embolism from a CT scan realized during the first week of patient care in intensive care unit.
Measured: Day 7
Predictive value of circulating levels of protein C (coagulation inhibitor) at inclusion on the occurrence of pulmonary embolism at day 7.
This biomarker is quantified from the blood sample collected at inclusion. The presence of pulmonary embolism from a CT scan realized during the first week of patient care in intensive care unit.
Measured: Day 7
Predictive value of circulating levels of protein S (coagulation inhibitor) at inclusion on the occurrence of pulmonary embolism at day 7.
This biomarker is quantified from the blood sample collected at inclusion. The presence of pulmonary embolism from a CT scan realized during the first week of patient care in intensive care unit.
Measured: Day 7
Predictive value of D-dimers (circulating fibrinolytic potential) at inclusion on the occurrence of pulmonary embolism at day 7.
This biomarker is quantified from the blood sample collected at inclusion. The presence of pulmonary embolism from a CT scan realized during the first week of patient care in intensive care unit.
Measured: Day 7
Predictive value of fibrin monomers (circulating fibrinolytic potential) at inclusion on the occurrence of pulmonary embolism at day 7.
This biomarker is quantified from the blood sample collected at inclusion. The presence of pulmonary embolism from a CT scan realized during the first week of patient care in intensive care unit.
Measured: Day 7
Predictive value of circulating PAI-1 (circulating fibrinolytic potential) at inclusion on the occurrence of pulmonary embolism at day 7.
This biomarker is quantified from the blood sample collected at inclusion. The presence of pulmonary embolism from a CT scan realized during the first week of patient care in intensive care unit.
Measured: Day 7
Predictive value of Willebrand antigen at inclusion on the occurrence of pulmonary embolism at day 28.
This biomarker is quantified from the blood sample collected 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.
Measured: Day 28
Predictive value of ADAMTS13 activity at inclusion on the occurrence of pulmonary embolism at day 28.
This biomarker is quantified from the blood sample collected 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.
Measured: Day 28
Predictive value of circulating levels of antithrombin (coagulation inhibitor) at inclusion on the occurrence of pulmonary embolism at day 28.
This biomarker is quantified from the blood sample collected 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.
Measured: Day 28
Predictive value of circulating levels of protein C (coagulation inhibitor) at inclusion on the occurrence of pulmonary embolism at day 28.
This biomarker is quantified from the blood sample collected 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.
Measured: Day 28
Predictive value of circulating levels of protein S (coagulation inhibitor) at inclusion on the occurrence of pulmonary embolism at day 28.
This biomarker is quantified from the blood sample collected 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.
Measured: Day 28
Predictive value of D-dimers (circulating fibrinolytic potential) at inclusion on the occurrence of pulmonary embolism at day 28.
This biomarker is quantified from the blood sample collected 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.
Measured: Day 28
Predictive value of fibrin monomers (circulating fibrinolytic potential) at inclusion on the occurrence of pulmonary embolism at day 28.
This biomarker is quantified from the blood sample collected 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.
Measured: Day 28
Predictive value of circulating PAI-1 (circulating fibrinolytic potential) at inclusion on the occurrence of pulmonary embolism at day 28.
This biomarker is quantified from the blood sample collected 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.
Measured: Day 28
Predictive value of Willebrand antigen at inclusion on the occurrence of venous thrombo-embolic disease at day 7.
This biomarker is quantified from the blood sample collected 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.
Measured: Day 7
Predictive value of ADAMTS13 activity at inclusion on the occurrence of venous thrombo-embolic disease at day 7.
This biomarker is quantified from the blood sample collected 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.
Measured: Day 7
Predictive value of circulating levels of antithrombin (coagulation inhibitor) at inclusion on the occurrence of venous thrombo-embolic disease at day 7.
This biomarker is quantified from the blood sample collected 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.
Measured: Day 7
Predictive value of circulating levels of protein C (coagulation inhibitor) at inclusion on the occurrence of venous thrombo-embolic disease at day 7.
This biomarker is quantified from the blood sample collected 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.
Measured: Day 7
Predictive value of circulating levels protein S (coagulation inhibitor) at inclusion on the occurrence of venous thrombo-embolic disease at day 7.
This biomarker is quantified from the blood sample collected 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.
Measured: Day 7
Predictive value of D-dimers (circulating fibrinolytic potential) at inclusion on the occurrence of venous thrombo-embolic disease at day 7.
This biomarker is quantified from the blood sample collected 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.
Measured: Day 7
Predictive value of fibrin monomers (circulating fibrinolytic potential) at inclusion on the occurrence of venous thrombo-embolic disease at day 7.
This biomarker is quantified from the blood sample collected 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.
Measured: Day 7
Predictive value of circulating PAI-1 (circulating fibrinolytic potential) at inclusion on the occurrence of venous thrombo-embolic disease at day 7.
This biomarker is quantified from the blood sample collected 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.
Measured: Day 7
Predictive value of Willebrand antigen at inclusion on the occurrence of venous thrombo-embolic disease at day 28.
This biomarker is quantified from the blood sample collected 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.
Measured: Day 28
Predictive value of ADAMTS13 activity at inclusion on the occurrence of venous thrombo-embolic disease at day 28.
This biomarker is quantified from the blood sample collected 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.
Measured: Day 28
Predictive value of circulating levels of antithrombin (coagulation inhibitor) at inclusion on the occurrence of venous thrombo-embolic disease at day 28.
This biomarker is quantified from the blood sample collected 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.
Measured: Day 28
Predictive value of circulating levels of protein C (coagulation inhibitor) at inclusion on the occurrence of venous thrombo-embolic disease at day 28.
This biomarker is quantified from the blood sample collected 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.
Measured: Day 28
Predictive value of circulating levels of protein S (coagulation inhibitor) at inclusion on the occurrence of venous thrombo-embolic disease at day 28.
This biomarker is quantified from the blood sample collected 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.
Measured: Day 28
Predictive value of D-dimers (circulating fibrinolytic potential) at inclusion on the occurrence of venous thrombo-embolic disease at day 28.
This biomarker is quantified from the blood sample collected 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.
Measured: Day 28
Predictive value of fibrin monomers (circulating fibrinolytic potential) at inclusion on the occurrence of venous thrombo-embolic disease at day 28.
This biomarker is quantified from the blood sample collected 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.
Measured: Day 28
Predictive value of circulating PAI-1 (circulating fibrinolytic potential) at inclusion on the occurrence of venous thrombo-embolic disease at day 28.
This biomarker is quantified from the blood sample collected 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.
Measured: Day 28
Predictive value of Willebrand antigen at inclusion on the patients' death.
This biomarker is quantified from the blood sample collected at inclusion. Occurrence of death is measured during the 2 months of follow up (or when the patient is discharged from hospital, if earlier).
Measured: Day 60
Predictive value of ADAMTS13 activity at inclusion on the patients' death.
This biomarker is quantified from the blood sample collected at inclusion. Occurrence of death is measured during the 2 months of follow up (or when the patient is discharged from hospital, if earlier).
Measured: Day 60
Predictive value of of circulating levels of antithrombin (coagulation inhibitor) at inclusion on the patients' death.
This biomarker is quantified from the blood sample collected at inclusion. Occurrence of death is measured during the 2 months of follow up (or when the patient is discharged from hospital, if earlier).
Measured: Day 60
Predictive value of of circulating levels of protein C (coagulation inhibitor) at inclusion on the patients' death.
This biomarker is quantified from the blood sample collected at inclusion. Occurrence of death is measured during the 2 months of follow up (or when the patient is discharged from hospital, if earlier).
Measured: Day 60
Predictive value of of circulating levels of protein S (coagulation inhibitor) at inclusion on the patients' death.
This biomarker is quantified from the blood sample collected at inclusion. Occurrence of death is measured during the 2 months of follow up (or when the patient is discharged from hospital, if earlier).
Measured: Day 60
Predictive value of D-dimers (circulating fibrinolytic potential) at inclusion on the patients' death.
This biomarker is quantified from the blood sample collected at inclusion. Occurrence of death is measured during the 2 months of follow up (or when the patient is discharged from hospital, if earlier).
Measured: Day 60
Predictive value of fibrin monomers (circulating fibrinolytic potential) at inclusion on the patients' death.
This biomarker is quantified from the blood sample collected at inclusion. Occurrence of death is measured during the 2 months of follow up (or when the patient is discharged from hospital, if earlier).
Measured: Day 60
Predictive value of circulating PAI-1 (circulating fibrinolytic potential) at inclusion on the patients' death.
This biomarker is quantified from the blood sample collected at inclusion. Occurrence of death is measured during the 2 months of follow up (or when the patient is discharged from hospital, if earlier).
Measured: Day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2023
- Study start31 Oct 2023
- Primary completion30 Oct 2027 (estimated)
- Study completion30 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François Cremieux, Study director, AP-HM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05855317
- Sponsor's protocol ID
- RCAPHM22_0440
- Other IDs
- ID-RCB
- Acronym
- THROMBO-EVTF
- Status last verified
- Feb 2026
- First submitted
- 3 May 2023
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05855317
- Acronym / sponsor ID
- THROMBO-EVTF / RCAPHM22_0440
- Conditions
- Acute Respiratory Distress Syndrome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 31 Oct 2023 (actual)
- Primary completion
- 30 Oct 2027 (estimated)
- Study completion
- 30 Oct 2027 (estimated)
- First posted
- 11 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with pulmonary embolism | – | Other: Blood sampleThe presence of pulmonary embolism is determined from a CT scan realized between Day 5 and Day 28. |
| Patients without pulmonary embolism | – | Other: Blood sampleThe absence of pulmonary embolism is determined from a CT scan realized between Day 5 and Day 28. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with ARDS admitted to the intensive care unit
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (8 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sampleAdditional blood samples will be taken on a catheter, used for standard care. | Other | Patients with pulmonary embolism, Patients without pulmonary embolism |
Primary outcome
Difference in EV-TF levels at inclusion between patients with and without pulmonary embolism at day 7 postinclusion
Time frame: Day 7
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.
51 secondary outcomes
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
Predictive value of ADAMTS13 activity at inclusion on the occurrence of pulmonary embolism at day 7.
Time frame: Day 7
Predictive value of circulating levels of antithrombin (coagulation inhibitor) at inclusion on the occurrence of pulmonary embolism at day 7.
Time frame: Day 7
Predictive value of circulating levels of protein C (coagulation inhibitor) at inclusion on the occurrence of pulmonary embolism at day 7.
Time frame: Day 7
Predictive value of circulating levels of protein S (coagulation inhibitor) at inclusion on the occurrence of pulmonary embolism at day 7.
Time frame: Day 7
Predictive value of D-dimers (circulating fibrinolytic potential) at inclusion on the occurrence of pulmonary embolism at day 7.
Time frame: Day 7
Predictive value of fibrin monomers (circulating fibrinolytic potential) at inclusion on the occurrence of pulmonary embolism at day 7.
Time frame: Day 7
Predictive value of circulating PAI-1 (circulating fibrinolytic potential) at inclusion on the occurrence of pulmonary embolism at day 7.
Time frame: Day 7
Predictive value of Willebrand antigen at inclusion on the occurrence of pulmonary embolism at day 28.
Time frame: Day 28
Predictive value of ADAMTS13 activity at inclusion on the occurrence of pulmonary embolism at day 28.
Time frame: Day 28
Predictive value of circulating levels of antithrombin (coagulation inhibitor) at inclusion on the occurrence of pulmonary embolism at day 28.
Time frame: Day 28
Predictive value of circulating levels of protein C (coagulation inhibitor) at inclusion on the occurrence of pulmonary embolism at day 28.
Time frame: Day 28
Predictive value of circulating levels of protein S (coagulation inhibitor) at inclusion on the occurrence of pulmonary embolism at day 28.
Time frame: Day 28
Predictive value of D-dimers (circulating fibrinolytic potential) at inclusion on the occurrence of pulmonary embolism at day 28.
Time frame: Day 28
Predictive value of fibrin monomers (circulating fibrinolytic potential) at inclusion on the occurrence of pulmonary embolism at day 28.
Time frame: Day 28
Predictive value of circulating PAI-1 (circulating fibrinolytic potential) at inclusion on the occurrence of pulmonary embolism at day 28.
Time frame: Day 28
Predictive value of Willebrand antigen at inclusion on the occurrence of venous thrombo-embolic disease at day 7.
Time frame: Day 7
Predictive value of ADAMTS13 activity at inclusion on the occurrence of venous thrombo-embolic disease at day 7.
Time frame: Day 7
Predictive value of circulating levels of antithrombin (coagulation inhibitor) at inclusion on the occurrence of venous thrombo-embolic disease at day 7.
Time frame: Day 7
Predictive value of circulating levels of protein C (coagulation inhibitor) at inclusion on the occurrence of venous thrombo-embolic disease at day 7.
Time frame: Day 7
Predictive value of circulating levels protein S (coagulation inhibitor) at inclusion on the occurrence of venous thrombo-embolic disease at day 7.
Time frame: Day 7
Predictive value of D-dimers (circulating fibrinolytic potential) at inclusion on the occurrence of venous thrombo-embolic disease at day 7.
Time frame: Day 7
Predictive value of fibrin monomers (circulating fibrinolytic potential) at inclusion on the occurrence of venous thrombo-embolic disease at day 7.
Time frame: Day 7
Predictive value of circulating PAI-1 (circulating fibrinolytic potential) at inclusion on the occurrence of venous thrombo-embolic disease at day 7.
Time frame: Day 7
Predictive value of Willebrand antigen at inclusion on the occurrence of venous thrombo-embolic disease at day 28.
Time frame: Day 28
Predictive value of ADAMTS13 activity at inclusion on the occurrence of venous thrombo-embolic disease at day 28.
Time frame: Day 28
Predictive value of circulating levels of antithrombin (coagulation inhibitor) at inclusion on the occurrence of venous thrombo-embolic disease at day 28.
Time frame: Day 28
Predictive value of circulating levels of protein C (coagulation inhibitor) at inclusion on the occurrence of venous thrombo-embolic disease at day 28.
Time frame: Day 28
Predictive value of circulating levels of protein S (coagulation inhibitor) at inclusion on the occurrence of venous thrombo-embolic disease at day 28.
Time frame: Day 28
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
François Cremieux study director
AP-HM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Respiratory Distress Syndrome, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Giovanni Bousquet, MD (0491964252 ext. 33, giovanni.bousquet@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in EV-TF levels at inclusion between patients with and without pulmonary embolism at day 7 postinclusion (time frame: Day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.