Implantation of a Veno-arterial or Veno-venous ECMO Clinical Trial
— ECMOstaseOfficial title:
Thrombin Generation as a New Test for Anticoagulation Management in Patients With ECMO
| NCT number | NCT03832842 |
| Other study ID # | 7251 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | May 16, 2019 |
| Est. completion date | February 1, 2021 |
| Verified date | February 2021 |
| Source | University Hospital, Strasbourg, France |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 30 |
| Est. completion date | February 1, 2021 |
| Est. primary completion date | December 4, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Male or female age = 18 years old - Implantation of a veno-arterial or veno-venous ECMO during hospitalization in intensive care - Informed consent Exclusion Criteria: - Patient on veno-arterial ECMO after cardiac, cardiopulmonary surgery or after insertion of a left or biventricular cardiac assist device - Contraindication to curative anticoagulation - Congenital hemostasis disorder or anatomical abnormality predisposing to hemorrhage (hemophilia, constitutional thrombocytopathies, Willebrand disease, hereditary hemorrhagic telangiectasia, etc.) - History of heparin-induced thrombocytopenia - Moribund patient at the day of inclusion - Do Not Resuscitate decision - Subject under the protection of justice - Subject under guardianship or curatorship - Pregnancy - Breastfeeding |
| Country | Name | City | State |
|---|---|---|---|
| France | Service de Réanimation médicale CHU Strasbourg | Strasbourg |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Strasbourg, France |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The endogenous thrombin potential (ETP) will be measured. | prior to ECMO placement at Hours 0 (ECMO circulation) | ||
| Primary | The endogenous thrombin potential (ETP) will be measured. | Hours 12 | ||
| Primary | The endogenous thrombin potential (ETP) will be measured. | daily from Day1 to Day10 and at each dosing of anti-Xa. | ||
| Secondary | Levels of hemostasis parameters: | thrombin generation test | daily from Day1 to Day10 | |
| Secondary | Levels of hemostasis parameters: | platelets | daily from Day1 to Day10 | |
| Secondary | Levels of hemostasis parameters: | anti-Xa | daily from Day1 to Day10 | |
| Secondary | Levels of hemostasis parameters: | aPTT | daily from Day1 to Day10 | |
| Secondary | Levels of hemostasis parameters: | prothrombin time | daily from Day1 to Day10 | |
| Secondary | Levels of hemostasis parameters: | fibrinogen | daily from Day1 to Day10 | |
| Secondary | Levels of hemostasis parameters: | factor V | daily from Day1 to Day10 | |
| Secondary | Levels of hemostasis parameters: | D-dimers | daily from Day1 to Day10 | |
| Secondary | Levels of hemostasis parameters: | antithrombin | daily from Day1 to Day10 | |
| Secondary | Levels of markers of vascular cell activation | microvesicles | daily from Day1 to Day10 | |
| Secondary | Levels of markers of vascular cell activation | neutrophil extra-cellular traps | daily from Day1 to Day10 | |
| Secondary | 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 | |
| Secondary | Incidence of thrombotic and ischemic events: ischemic stroke, limb ischemia, myocardial infarction, ECMO thrombosis | daily from Day1 to Day10 | ||
| Secondary | Mortality: number of patients who are dead by day 28 | day 28 |