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ECMO (Extracorporeal Membrane Oxygenation) is a circulatory assistance device aiming at maintaining or restoring cardiopulmonary circulation. Complications of this device are mainly hemorrhagic, related to coagulopathy induced by the initial pathology or by the device itself, or thrombotic and ischemic. One of the major challenges is therefore the management of a suitable curative anticoagulation, sufficient to limit the activation of hemostasis du to the ECMO, but reasonable to prevent hemorrhagic complications. To date, there is no standardized and validated protocol for the management of anticoagulation of patients under ECMO. The thrombin generation may be a valuable test to manage anticoagulation of patients with ECMO.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood sample | Diagnostic Test | Blood sample |
| Measure | Description | Time Frame |
|---|---|---|
| The endogenous thrombin potential (ETP) will be measured. | prior to ECMO placement at Hours 0 (ECMO circulation) | |
| The endogenous thrombin potential (ETP) will be measured. | Hours 12 | |
| The endogenous thrombin potential (ETP) will be measured. | daily from Day1 to Day10 and at each dosing of anti-Xa. |
| Measure | Description | Time Frame |
|---|---|---|
| Levels of hemostasis parameters: | thrombin generation test | daily from Day1 to Day10 |
| Levels of hemostasis parameters: | platelets | daily from Day1 to Day10 |
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Inclusion Criteria:
Exclusion Criteria:
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Implantation of a veno-arterial or veno-venous ECMO during hospitalization in intensive care unit
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| Name | Affiliation | Role |
|---|---|---|
| Julie HELMS, MD, PhD | University Hospital, Strasbourg, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de Réanimation médicale CHU Strasbourg | Strasbourg | 67091 | France |
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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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Whole blood and serum will be sampled.
| Levels of hemostasis parameters: | anti-Xa | daily from Day1 to Day10 |
| Levels of hemostasis parameters: | aPTT | daily from Day1 to Day10 |
| Levels of hemostasis parameters: | prothrombin time | daily from Day1 to Day10 |
| Levels of hemostasis parameters: | fibrinogen | daily from Day1 to Day10 |
| Levels of hemostasis parameters: | factor V | daily from Day1 to Day10 |
| Levels of hemostasis parameters: | D-dimers | daily from Day1 to Day10 |
| Levels of hemostasis parameters: | antithrombin | daily from Day1 to Day10 |
| Levels of markers of vascular cell activation | microvesicles | daily from Day1 to Day10 |
| Levels of markers of vascular cell activation | neutrophil extra-cellular traps | daily from Day1 to Day10 |
| Incidence of bleeding events defined by the WHO classification, | type of bleeding (venous or arterial), blood/platelet/plasma transfusion (number, volume), fibrinogen treatment, calcium treatment, therapeutic intervention (surgical/radiological/endoscopic/manual) | daily from Day1 to Day10 |
| Incidence of thrombotic and ischemic events: ischemic stroke, limb ischemia, myocardial infarction, ECMO thrombosis | daily from Day1 to Day10 |
| Mortality: number of patients who are dead by day 28 | day 28 |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |