Implantation of a Veno-arterial or Veno-venous ECMO
Conditions
Keywords
ECMO, thrombin generation test, hemostasis, bleeding events, thrombotic events
Brief summary
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.
Interventions
DIAGNOSTIC_TESTBlood sample
Blood sample
Sponsors
University Hospital, Strasbourg, France
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The endogenous thrombin potential (ETP) will be measured. | prior to ECMO placement at Hours 0 (ECMO circulation) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Levels of hemostasis parameters: | daily from Day1 to Day10 | thrombin generation test |
| Levels of markers of vascular cell activation | daily from Day1 to Day10 | microvesicles |
| Incidence of bleeding events defined by the WHO classification, | daily from Day1 to Day10 | type of bleeding (venous or arterial), blood/platelet/plasma transfusion (number, volume), fibrinogen treatment, calcium treatment, therapeutic intervention (surgical/radiological/endoscopic/manual) |
| 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 | — |
Countries
France
Outcome results
None listed