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OpenTrials
Completed

NCT Number: NCT03832842

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

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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Key information

Conditions

Implantation of a Veno-arterial or Veno-venous ECMO

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Service de Réanimation médicale CHU Strasbourg

Strasbourg, 67091, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood sample

Diagnostic Test

Blood sample

Primary outcomes

  1. The endogenous thrombin potential (ETP) will be measured.

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

  2. The endogenous thrombin potential (ETP) will be measured.

    Time frame: Hours 12

  3. The endogenous thrombin potential (ETP) will be measured.

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

Secondary outcomes

  1. Levels of hemostasis parameters:

    Time frame: daily from Day1 to Day10

    thrombin generation test

  2. Levels of hemostasis parameters:

    Time frame: daily from Day1 to Day10

    platelets

  3. Levels of hemostasis parameters:

    Time frame: daily from Day1 to Day10

    anti-Xa

  4. Levels of hemostasis parameters:

    Time frame: daily from Day1 to Day10

    aPTT

  5. Levels of hemostasis parameters:

    Time frame: daily from Day1 to Day10

    prothrombin time

  6. Levels of hemostasis parameters:

    Time frame: daily from Day1 to Day10

    fibrinogen

  7. Levels of hemostasis parameters:

    Time frame: daily from Day1 to Day10

    factor V

  8. Levels of hemostasis parameters:

    Time frame: daily from Day1 to Day10

    D-dimers

  9. Levels of hemostasis parameters:

    Time frame: daily from Day1 to Day10

    antithrombin

  10. Levels of markers of vascular cell activation

    Time frame: daily from Day1 to Day10

    microvesicles

  11. Levels of markers of vascular cell activation

    Time frame: daily from Day1 to Day10

    neutrophil extra-cellular traps

  12. Incidence of bleeding events defined by the WHO classification,

    Time frame: 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)

  13. Incidence of thrombotic and ischemic events: ischemic stroke, limb ischemia, myocardial infarction, ECMO thrombosis

    Time frame: daily from Day1 to Day10

  14. Mortality: number of patients who are dead by day 28

    Time frame: day 28

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Acronym: ECMOstase

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Feb 6, 2019
Registry last updated
Feb 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.