BivaLirudin versUS Heparin in Extracorporeal Membrane Oxygenation

• Status: Not yet recruiting
• Trial end date: 2026-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sydney Local Health District
• Treatments: Bivalirudin; Calcium heparin; Heparin

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