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| ID | Type | Description | Link |
|---|---|---|---|
| ID-RCB | Other Identifier | 2023-A00413-42 |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with pulmonary embolism | The presence of pulmonary embolism is determined from a CT scan realized between Day 5 and Day 28. |
| |
| Patients without pulmonary embolism | The absence of pulmonary embolism is determined from a CT scan realized between Day 5 and Day 28. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood sample | Other | Additional blood samples will be taken on a catheter, used for standard care. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 28 |
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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,
Exclusion Criteria:
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Patients with ARDS admitted to the intensive care unit
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Giovanni Bousquet, MD | Contact | 0491964252 | 33 | giovanni.bousquet@ap-hm.fr |
| Christophe Guervilly, MD | Contact | 0491965842 | 33 | christophe.guervilly@ap-hm.fr |
| Name | Affiliation | Role |
|---|---|---|
| François Cremieux | AP-HM | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service Médecine intensive et réanimation | Recruiting | Marseille | 13015 | France |
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| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| 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. |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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). | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | Day 60 |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |