Clinical trial NCT03832842: Thrombin Generation as a New Test for Anticoagulation Management in Patients With ECMO
Official title: Thrombin Generation as a New Test for Anticoagulation Management in Patients With ECMO
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Implantation of a Veno-arterial or Veno-venous ECMO
Keywords: ECMO
thrombin generation test
hemostasis
bleeding events
thrombotic events
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2019-02-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Implantation of a veno-arterial or veno-venous ECMO during hospitalization in intensive care unit

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.


Eligibility criteria: 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

Primary outcomes:
measure: The endogenous thrombin potential (ETP) will be measured.
timeFrame: prior to ECMO placement at Hours 0 (ECMO circulation)
measure: The endogenous thrombin potential (ETP) will be measured.
timeFrame: Hours 12
measure: The endogenous thrombin potential (ETP) will be measured.
timeFrame: daily from Day1 to Day10 and at each dosing of anti-Xa.
Secondary outcomes:
measure: Levels of hemostasis parameters:
timeFrame: daily from Day1 to Day10
measure: Levels of hemostasis parameters:
timeFrame: daily from Day1 to Day10
measure: Levels of hemostasis parameters:
timeFrame: daily from Day1 to Day10
measure: Levels of hemostasis parameters:
timeFrame: daily from Day1 to Day10
measure: Levels of hemostasis parameters:
timeFrame: daily from Day1 to Day10
measure: Levels of hemostasis parameters:
timeFrame: daily from Day1 to Day10
measure: Levels of hemostasis parameters:
timeFrame: daily from Day1 to Day10
measure: Levels of hemostasis parameters:
timeFrame: daily from Day1 to Day10
measure: Levels of hemostasis parameters:
timeFrame: daily from Day1 to Day10
measure: Levels of markers of vascular cell activation
timeFrame: daily from Day1 to Day10
measure: Levels of markers of vascular cell activation
timeFrame: daily from Day1 to Day10
measure: Incidence of bleeding events defined by the WHO classification,
timeFrame: daily from Day1 to Day10
measure: Incidence of thrombotic and ischemic events: ischemic stroke, limb ischemia, myocardial infarction, ECMO thrombosis
timeFrame: daily from Day1 to Day10
measure: Mortality: number of patients who are dead by day 28
timeFrame: day 28
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Réanimation médicale CHU Strasbourg
Study officials:
affiliation: University Hospital, Strasbourg, France
name: Julie HELMS, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: