RecruitingPhase 2

BivaLirudin versUS Heparin in Extracorporeal Membrane Oxygenation

Australia80 participantsStarted 2024-05-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Time in therapeutic range

Timeframe: 30 days

Trial details

NCT IDNCT05959252

SponsorSydney Local Health District

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2026-06-01

View on ClinicalTrials.gov More Extracorporeal Membrane Oxygenation Complication trials