BivaLirudin versUS Heparin in Extracorporeal Membrane Oxygenation

PHASE2RECRUITING

The goal of this open label randomised clinical trial is to compare Bivalirudin versus Heparin for anticoagulation in patients requiring extracorporeal membrane oxygenation support. The main question it aims to answer are include the ability to maintain anticoagulation within defined therapeutic range, bleeding and thrombotic complications and a comparison of the total cost of anticoagulation care. Participants will be randomised to either anticoagulation with Bivalirudin or anticoagulation with Unfractionated Heparin.

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Study details:

Rationale:. Anticoagulation whilst on extracorporeal membrane oxygenation (ECMO) is required. Bleeding and thrombotic complications whilst on ECMO are common and may effect the patient outcome.

The optimal anticoagulant for ECMO patients is not clear and there exists no randomised control trial data comparing anticoagulants on ECMO. This Phase 2b trial will provide data to enable larger definitive phase III trials to determine the best anticoagulant whilst on ECMO. Hypothesis: Hypothesis: In adults ECMO patients'; anticoagulation with Bivalirudin results in more samples within therapeutic range than unfractionated Heparin.

Total anticoagulation costs with Bivalirudin are similar to unfractionated Heparin. The objectives of this study is to assess anticoagulation protocol of bivalirudin versus unfractionated heparin and assess the to the cost of each protocol.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

  • Patients receiving ECMO
  • Age: 18 years or older
  • Ability to randomise the patient within 4 hours of ECMO support initiation
  • Exclusion criteria

  • Post-cardiotomy ECMO patients
  • Contraindication to heparin or bivalirudin at time of randomisation e.g., active bleeding
  • Heparin induced thrombotic thrombocytopenia syndrome
  • Where the patient is expected to be disconnected from ECMO in the next day after cannulation.
  • Limitations of care put in place either through patient wishes or the treating medical teams
  • Other reason where the treating physician deems the study is not in the patient's best interest
  • Patients who are suspected or confirmed to be pregnant
  • Inherited bleeding or thrombotic disorders, Systemic Lupus Erythematosus patients
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    Eligibility

    Age eligible for study : 18 and older

    Healthy volunteers accepted : No

    Gender eligible for study: All

    Things to know

    Study dates

    Study start: 2024-05-01

    Primary completion: 2025-12-01

    Study completion finish: 2026-05-01

    study type

    Study type

    TREATMENT

    phase

    Phase

      PHASE2

    trial

    Trial ID

    NCT05959252

    Intervention or treatment

    DRUG: Unfractionated heparin

    DRUG: Bivalirudin

    Conditions

    • Extracorporeal Membrane Oxygenation Complication
    Image related to Extracorporeal Membrane Oxygenation Complication
    • Condition: Extracorporeal Membrane Oxygenation Complication

    • DRUG: Unfractionated heparin and other drugs

    • Sydney, New South Wales, Australia

    • Sponsor: Sydney Local Health District

    Find a site

    Closest Location:

    Royal Prince Alfred Hospital

    Research sites nearby

    Select from list below to view details:

    • Royal Prince Alfred Hospital

      Sydney, New South Wales, Australia

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    Study Plan

    This section provides details of the study plan, including how the study is designed and what the study is measuring.

    How is the study designed?

    Participant Group/ArmIntervention/Treatment
    ACTIVE_COMPARATOR: Bivalirudin
    • Bivalirudin protocol with target activated thromboplastin time (aPTT) of 50-70 seconds
    DRUG: Bivalirudin
    • Bivalirudin protocol with target aPTT 50-70 seconds
    ACTIVE_COMPARATOR: Unfractionated Heparin
    • Unfractionated heparin protocol with target anti-Xa of 0.3-0.5 IU/mL
    DRUG: Unfractionated heparin
    • Unfractionated Heparin protocol with target anti-Xa of 0.3-0.5 IU/mL

    What is the study measuring?

    Primary outcome

    Primary Outcome MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    Time in therapeutic rangeProportion of monitoring samples within therapeutic range30 days

    Secondary outcome

    Secondary Outcome MeasureSecondary Outcome DescriptionSecondary Outcome Time Frame
    Enrolment rateEnrolment rate30 days
    Reasons for non-enrolmentReasons for non-enrolment of eligible patients into the study30 days
    Crossover between armsThe number of cross over patients between arms of the study30 days
    Circuit changesThe number of circuit changes and length of circuit life30 days
    Daily mean aPTT and anti-XaDaily mean aPTT and anti-Xa versus stated range30 days
    Serious adverse events (SAEs)Number of SAEs30 days
    Protocol violationsNumber of protocol violations30 days
    Thrombotic eventsNumber of deep vein thrombosis identified by ultrasound or CT30 days
    Major bleeding events defined by International Society of Thrombosis and Haemostasis (ISTH)Major bleeding was defined according to the criteria as clinically overt bleeding which was fatal or associated with any of the following: (a) a fall in hemoglobin level of 2 g/dL or more or documented transfusion of at least 2 units of packed red blood cells, (b) involvement of a critical anatomical site (intracranial, spinal, ocular, pericardial, articular, intramuscular with compartment syndrome, retroperitoneal)30 days
    Bleeding events defined by Bleeding Academic Research Consortium (BARC)Number of bleeding events as per BARC Hemorrhagic complications assessed and adapted as per Bleeding Academic Research Consortium (BARC) Type 0: No bleeding Type 1: Bleeding requiring transfusion of packed red blood cells (PRBC) or reduction of unfractionated heparin Type 2: Bleeding requiring transfusion of PRBC and reduction of unfractionated heparin Type 3: Life-threatening bleeding requiring, transfusion of PRBC, surgical intervention or discontinuation of ECMO Type 4: Any fatal bleeding30 days
    Survival to Intensive care Unit (ICU) dischargeSurvival to discharge from ICU (percentage of patients surviving to ICU discharge)30 days
    Survival to hospital dischargeHospital Survival (percentage of patients surviving hospital discharge)30 days
    Blood product usageTotal amount of red blood cells (RBC), platelets, plasma and blood products used during extracorporeal membrane oxygenation support30 days
    CostTotal cost of of extracorporeal membrane oxygenation support that includes blood products, blood tests and complications (measured in United States dollars)30 days

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    References

    Clinical Trials Gov: BivaLirudin versUS Heparin in Extracorporeal Membrane Oxygenation

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