Comparing Bivalirudin and Heparin for Anticoagulation in ECMO Patients
BivaLirudin versUS Heparin in ECMO - A Registry-embedded, Randomised, Open Label, Feasibility Trial Comparing Two Anticoagulation Strategies in Patients on Extracorporeal Membrane Oxygenation (ECMO)
This study is testing whether Bivalirudin works better than Heparin for preventing blood clots in patients on ECMO while also checking for bleeding risks and costs.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sydney Local Health District Government |
| Locations | 1 site (Sydney, New South Wales) |
| Trial ID | NCT05959252 on ClinicalTrials.gov |
What this trial studies
This open-label randomized clinical trial aims to compare the effectiveness of Bivalirudin versus Unfractionated Heparin for anticoagulation in patients requiring extracorporeal membrane oxygenation (ECMO). The study will assess the ability to maintain anticoagulation within a defined therapeutic range, as well as the incidence of bleeding and thrombotic complications. Additionally, it will evaluate the total cost associated with each anticoagulation method. Participants will be randomly assigned to receive either Bivalirudin or Heparin within four hours of ECMO support initiation.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 years or older who are receiving ECMO support.
Not a fit: Patients who are post-cardiotomy ECMO, have contraindications to heparin or bivalirudin, or have limitations of care in place may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved anticoagulation management in ECMO patients, potentially reducing complications and healthcare costs.
How similar studies have performed: This approach is novel as there are currently no randomized control trials comparing anticoagulants specifically for ECMO patients.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Sydney, New South Wales
- Royal Prince Alfred Hospital — Sydney, New South Wales, Australia (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.