BivaLirudin versUS Heparin in Extracorporeal Membrane Oxygenation
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1 other identifier
interventional
80
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started May 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 2, 2023
CompletedFirst Posted
Study publicly available on registry
July 25, 2023
CompletedStudy Start
First participant enrolled
May 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2026
ExpectedMay 8, 2026
May 1, 2026
2.1 years
July 2, 2023
May 7, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time in therapeutic range
Proportion of monitoring samples within therapeutic range
30 days
Secondary Outcomes (14)
Enrolment rate
30 days
Reasons for non-enrolment
30 days
Crossover between arms
30 days
Circuit changes
30 days
Daily mean aPTT and anti-Xa
30 days
- +9 more secondary outcomes
Study Arms (2)
Bivalirudin
ACTIVE COMPARATORBivalirudin protocol with target activated thromboplastin time (aPTT) of 50-70 seconds
Unfractionated Heparin
ACTIVE COMPARATORUnfractionated heparin protocol with target anti-Xa of 0.3-0.5 IU/mL
Interventions
Unfractionated Heparin protocol with target anti-Xa of 0.3-0.5 IU/mL
Eligibility Criteria
You may qualify if:
- Patients receiving ECMO
- Age: 18 years or older
- Ability to randomise the patient within 4 hours of ECMO support initiation
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Royal Prince Alfred Hospital
Sydney, New South Wales, 2050, Australia
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 2, 2023
First Posted
July 25, 2023
Study Start
May 1, 2024
Primary Completion
June 1, 2026
Study Completion (Estimated)
September 1, 2026
Last Updated
May 8, 2026
Record last verified: 2026-05