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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-05-16

Study Completion Date

2021-02-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Implantation of a Veno-arterial or Veno-venous ECMO

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Blood sample

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No