DRUG
Unfractionated heparin
Unfractionated Heparin protocol with target anti-Xa of 0.3-0.5 IU/mL
BivaLirudin versUS Heparin in Extracorporeal Membrane Oxygenation
Status
Recruiting
Phase
Phase 2
Enrollment
80
Locations
1
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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.
Full detailed description
Rationale: Anticoagulation whilst on extracorporeal membrane oxygenation (ECMO) is required. Bleeding and thrombotic complications whilst on ECMO are common and may effect the patient outcome. The optimal anticoagulant for ECMO patients is not clear and there exists no randomised control trial data comparing anticoagulants on ECMO. This Phase 2b trial will provide data to enable larger definitive phase III trials to determine the best anticoagulant whilst on ECMO. Hypothesis: Hypothesis: In adults ECMO patients'; anticoagulation with Bivalirudin results in more samples within therapeutic range than unfractionated Heparin. Total anticoagulation costs with Bivalirudin are similar to unfractionated Heparin. The objectives of this study is to assess anticoagulation protocol of bivalirudin versus unfractionated heparin and assess the to the cost of each protocol.
Interventions
Treatment arms and agents.
DRUG
Bivalirudin
Bivalirudin protocol with target aPTT 50-70 seconds
Timeline
From registration to results.
First posted
Jul 25, 2023
Study start
May 1, 2024
Primary completion
Jun 1, 2026
Study completion
Sep 1, 2026
Results posted
Not reported
Registry updated
May 8, 2026
Outcomes
What the study measures.
Primary outcomes
Time in therapeutic range
Time frame · 30 days
Proportion of monitoring samples within therapeutic range
Secondary outcomes
Enrolment rate
Time frame · 30 days
Enrolment rate
Reasons for non-enrolment
Time frame · 30 days
Reasons for non-enrolment of eligible patients into the study
Crossover between arms
Time frame · 30 days
The number of cross over patients between arms of the study
Circuit changes
Time frame · 30 days
The number of circuit changes and length of circuit life
Daily mean aPTT and anti-Xa
Time frame · 30 days
Daily mean aPTT and anti-Xa versus stated range
Serious adverse events (SAEs)
Time frame · 30 days
Number of SAEs
Protocol violations
Time frame · 30 days
Number of protocol violations
Thrombotic events
Time frame · 30 days
Number of deep vein thrombosis identified by ultrasound or CT
Major bleeding events defined by International Society of Thrombosis and Haemostasis (ISTH)
Time frame · 30 days
Major bleeding was defined according to the criteria as clinically overt bleeding which was fatal or associated with any of the following: (a) a fall in hemoglobin level of 2 g/dL or more or documented transfusion of at least 2 units of packed red blood cells, (b) involvement of a critical anatomical site (intracranial, spinal, ocular, pericardial, articular, intramuscular with compartment syndrome, retroperitoneal)
Bleeding events defined by Bleeding Academic Research Consortium (BARC)
Time frame · 30 days
Number of bleeding events as per BARC Hemorrhagic complications assessed and adapted as per Bleeding Academic Research Consortium (BARC) Type 0: No bleeding Type 1: Bleeding requiring transfusion of packed red blood cells (PRBC) or reduction of unfractionated heparin Type 2: Bleeding requiring transfusion of PRBC and reduction of unfractionated heparin Type 3: Life-threatening bleeding requiring, transfusion of PRBC, surgical intervention or discontinuation of ECMO Type 4: Any fatal bleeding
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- No
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
Study locations
1 registered sites.
Australia. Showing up to 24 locations stored in the fast local snapshot.
Royal Prince Alfred Hospital
Sydney, New South Wales, Australia
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
Related trials
More studies on Bivalirudin.
NCT IDStudyPhase / statusEnrollmentUpdated
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Not applicable
Recruiting
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2026-04
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Phase 4
Not yet recruiting
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Multicenter Trial of ECMO in Children With Severe Cardiac Failure Using the Cardiohelp System
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Phase 2
Recruiting
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A Single Center Diagnostic, Cross-sectional Study of Coronary Microvascular Dysfunction
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Not applicable
Active, not recruiting
206
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Not applicable
Completed
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A Study on the Impact of Bivalirudin Usage During PCI for High-risk Plaques on Post-PCI Coronary Microcirculation.
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Phase 4
Recruiting
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Not applicable
Recruiting
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Put the record in context.
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