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Recruiting NCT05959252

BivaLirudin versUS Heparin in Extracorporeal Membrane Oxygenation

Phase II Interventional Extracorporeal Membrane Oxygenation Complication

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Unfractionated heparin, Bivalirudin.
Who it may be relevant to
Registry conditions: Extracorporeal Membrane Oxygenation Complication. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Australia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

BivaLirudin versUS Heparin in ECMO - A Registry-embedded, Randomised, Open Label, Feasibility Trial Comparing Two Anticoagulation Strategies in Patients on Extracorporeal Membrane Oxygenation (ECMO)

Overview

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.

Detailed description

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.

Interventions

  • Drug Unfractionated heparin
    Unfractionated Heparin protocol with target anti-Xa of 0.3-0.5 IU/mL
  • Drug Bivalirudin
    Bivalirudin protocol with target aPTT 50-70 seconds

Primary outcome measures

  • Time in therapeutic range [Time frame: 30 days]
Secondary outcome measures (12)
  • Enrolment rate [Time frame: 30 days]
  • Reasons for non-enrolment [Time frame: 30 days]
  • Crossover between arms [Time frame: 30 days]
  • Circuit changes [Time frame: 30 days]
  • Daily mean aPTT and anti-Xa [Time frame: 30 days]
  • Serious adverse events (SAEs) [Time frame: 30 days]
  • Protocol violations [Time frame: 30 days]
  • Thrombotic events [Time frame: 30 days]
  • Major bleeding events defined by International Society of Thrombosis and Haemostasis (ISTH) [Time frame: 30 days]
  • Bleeding events defined by Bleeding Academic Research Consortium (BARC) [Time frame: 30 days]
  • Survival to Intensive care Unit (ICU) discharge [Time frame: 30 days]
  • Survival to hospital discharge [Time frame: 30 days]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Australia · 1 center
  • Royal Prince Alfred Hospital — Sydney

Identifiers

NCT: NCT05959252 · 2023/ETH00443

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗