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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03832842
Recruitment Status : Completed
First Posted : February 6, 2019
Last Update Posted : February 4, 2021
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

Study Description
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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.

Condition or disease Intervention/treatment
Implantation of a Veno-arterial or Veno-venous ECMO Diagnostic Test: Blood sample

Study Design
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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Thrombin Generation as a New Test for Anticoagulation Management in Patients With ECMO
Actual Study Start Date : May 16, 2019
Actual Primary Completion Date : December 4, 2020
Actual Study Completion Date : February 1, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Thrombin

Groups and Cohorts
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Intervention Details:
  • Diagnostic Test: Blood sample
    Blood sample

Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Biospecimen Retention:   Samples Without DNA
Whole blood and serum will be sampled.

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Implantation of a veno-arterial or veno-venous ECMO during hospitalization in intensive care unit
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03832842


Locations
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France
Service de Réanimation médicale CHU Strasbourg
Strasbourg, France, 67091
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
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Principal Investigator: Julie HELMS, MD, PhD University Hospital, Strasbourg, France
More Information
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Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT03832842    
Other Study ID Numbers: 7251
First Posted: February 6, 2019    Key Record Dates
Last Update Posted: February 4, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Strasbourg, France:
ECMO
thrombin generation test
hemostasis
bleeding events
thrombotic events