Actively Recruiting
Bivalirudin versus Heparin in ECMO - A Randomised, Open Label, Feasibility Trial Comparing Two Anticoagulation Strategies in Patients on Extracorporeal Membrane Oxygenation
Led by Sydney Local Health District · Updated on 2026-05-08
80
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are comparing two anticoagulation treatments, Bivalirudin and Unfractionated Heparin, for adults needing extracorporeal membrane oxygenation (ECMO) support. This Phase 2b open-label randomized trial aims to find which anticoagulant maintains blood thinning within a target range better, while also assessing bleeding, clotting problems, and the overall cost of care. The study is sponsored by Sydney Local Health District and addresses the lack of randomized trial data for anticoagulants during ECMO. Participants will be randomly assigned to receive either Bivalirudin with a target activated thromboplastin time (aPTT) of 50-70 seconds or Unfractionated Heparin targeting anti-Xa levels of 0.3-0.5 IU/mL. The trial evaluates the effectiveness of these two anticoagulation protocols over the study period. During the 30-day study, researchers will monitor how long patients stay within the therapeutic range, track bleeding and clotting events, record anticoagulation costs, and observe other outcomes such as survival to ICU and hospital discharge. The trial includes assessments of adverse events, blood product use, and protocol adherence to provide comprehensive safety and effectiveness data for the treatments.
CONDITIONS
Brief Title
BivaLirudin versUS Heparin in Extracorporeal Membrane Oxygenation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients receiving ECMO
- Age 18 years or older
- Ability to randomise the patient within 4 hours of ECMO support initiation
You will not qualify if you...
- Post-cardiotomy ECMO patients
- Contraindication to heparin or bivalirudin at time of randomisation such as active bleeding
- Heparin induced thrombotic thrombocytopenia syndrome
- Expected disconnection from ECMO within one day after cannulation
- Limitations of care due to patient wishes or medical team decisions
- Treating physician deems study not in patient's best interest
- Suspected or confirmed pregnancy
- Inherited bleeding or thrombotic disorders
- Systemic Lupus Erythematosus patients
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 30 days or until ECMO support ends
Participants receive anticoagulation with either Bivalirudin or Unfractionated Heparin while on extracorporeal membrane oxygenation (ECMO).
Daily visits during ECMO support
Trial Site Locations
Total: 1 location
1
Royal Prince Alfred Hospital
Sydney, New South Wales, Australia, 2050
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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