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

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 Overview

• Status: Completed
• Conditions: Implantation of a Veno-arterial or Veno-venous ECMO
• Intervention / Treatment: Diagnostic test: Blood sample

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• France
  • Strasbourg, France, 67091
    • Service de Réanimation médicale CHU Strasbourg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Implantation of a veno-arterial or veno-venous ECMO during hospitalization in intensive care unit

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The endogenous thrombin potential (ETP) will be measured.	prior to ECMO placement at Hours 0 (ECMO circulation)
The endogenous thrombin potential (ETP) will be measured.	Hours 12
The endogenous thrombin potential (ETP) will be measured.	daily from Day1 to Day10 and at each dosing of anti-Xa.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Levels of hemostasis parameters:	thrombin generation test	daily from Day1 to Day10
Levels of hemostasis parameters:	platelets	daily from Day1 to Day10
Levels of hemostasis parameters:	anti-Xa	daily from Day1 to Day10
Levels of hemostasis parameters:	aPTT	daily from Day1 to Day10
Levels of hemostasis parameters:	prothrombin time	daily from Day1 to Day10
Levels of hemostasis parameters:	fibrinogen	daily from Day1 to Day10
Levels of hemostasis parameters:	factor V	daily from Day1 to Day10
Levels of hemostasis parameters:	D-dimers	daily from Day1 to Day10
Levels of hemostasis parameters:	antithrombin	daily from Day1 to Day10
Levels of markers of vascular cell activation	microvesicles	daily from Day1 to Day10
Levels of markers of vascular cell activation	neutrophil extra-cellular traps	daily from Day1 to Day10
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
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

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France
• Investigators: Principal Investigator: Julie HELMS, MD, PhD, University Hospital, Strasbourg, France

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 16, 2019
• Primary Completion (ACTUAL): December 4, 2020
• Study Completion (ACTUAL): February 1, 2021

Study Registration Dates

• First Submitted: January 23, 2019
• First Submitted That Met QC Criteria: February 5, 2019
• First Posted (ACTUAL): February 6, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 4, 2021
• Last Update Submitted That Met QC Criteria: February 1, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: ECMO; hemostasis; thrombotic events; bleeding events; thrombin generation test
• Other Study ID Numbers: 7251 (CTEP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No