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

Completed

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

• Registration Number: NCT03832842
• Lead Sponsor: University Hospital, Strasbourg, France

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-01-23
• Study First Submitted QC: 2019-02-05
• Study First Posted: 2019-02-06
• Study Start: 2019-05-16
• Primary Completion: 2020-12-04
• Status Verified: 2021-02
• Study Completion: 2021-02-01
• Last Update Submitted: 2021-02-01
• Last Update Posted: 2021-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The endogenous thrombin potential (ETP) will be measured.	daily from Day1 to Day10 and at each dosing of anti-Xa.

Secondary Outcome Measures

Name	Time	Method
Levels of markers of vascular cell activation	daily from Day1 to Day10	neutrophil extra-cellular traps
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
Levels of hemostasis parameters:	daily from Day1 to Day10	antithrombin
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)

Trial Locations

Locations (1)

Service de Réanimation médicale CHU Strasbourg; 🇫🇷 Strasbourg, France