BivaLirudin versUS Heparin in Extracorporeal Membrane Oxygenation

NCT05959252 · tracked via the Priya Life Science Australia tracker

Sponsor

Sydney Local Health District

Phase

Phase 2

Started

2024-05-01

Last updated

2026-05-08

Condition(s) studied

Extracorporeal Membrane Oxygenation Complication

Investigational drug(s) / intervention(s)

Unfractionated heparin →Bivalirudin →

Unfractionated heparin: Unfractionated Heparin protocol with target anti-Xa of 0.3-0.5 IU/mL

Bivalirudin: Bivalirudin protocol with target aPTT 50-70 seconds

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Time in therapeutic range — 30 days
Proportion of monitoring samples within therapeutic range

Trial sites (1)

Facility	City	Region	Status
Royal Prince Alfred Hospital	Sydney	New South Wales	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05959252 on ClinicalTrials.gov ↗ ← All trials in Australia