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 range

18 Years

Sex

ALL

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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