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

University Hospital, Strasbourg, France30 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Implantation of a Veno-arterial or Veno-venous ECMO

Interventions

Blood sampleDIAGNOSTIC_TEST

Blood sample

Eligibility

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

The endogenous thrombin potential (ETP) will be measured.

Time frame: prior to ECMO placement at Hours 0 (ECMO circulation)

The endogenous thrombin potential (ETP) will be measured.

Time frame: Hours 12

The endogenous thrombin potential (ETP) will be measured.

Time frame: daily from Day1 to Day10 and at each dosing of anti-Xa.