Actively Recruiting
BivaLirudin versUS Heparin in Extracorporeal Membrane Oxygenation
Led by Sydney Local Health District · Updated on 2026-05-08
80
Participants Needed
1
Research Sites
121 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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
- Other reasons where the treating physician deems participation not in the 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
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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