Thrombin Generation as a New Test for Anticoagulation Management in Patients With ECMO (ECMOstase)

University Hospital, Strasbourg, France

Status: Completed

Conditions: Implantation of a Veno-arterial or Veno-venous ECMO

Treatments: Diagnostic Test: Blood sample

Study type: Observational

Funder types: Other

Identifiers

NCT03832842

7251 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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