BivaLirudin versUS Heparin in Extracorporeal Membrane Oxygenation
NCT ID: NCT05959252
Last Updated: 2024-08-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE2
80 participants
INTERVENTIONAL
2024-05-01
2026-05-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Safety and Efficacy of Bivalirudin Versus Heparin for Systemic Anticoagulation in Extracorporeal Membrane Oxygenation
NCT03965208
Use of Bivalirudin for Anticoagulation in Patients With Extracorporeal Membrane Oxygenation
NCT06275555
Bivalirudin vs Heparin in ECMO Patients
NCT03707418
Veno-venous Extracorporeal Membrane Oxygenation (VV-ECMO) Heparin Study
NCT04496362
Bivalirudin Versus Enoxaparin in Critically Ill COVID-19 Patients
NCT05334654
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Bivalirudin
Bivalirudin protocol with target activated thromboplastin time (aPTT) of 50-70 seconds
Bivalirudin
Bivalirudin protocol with target aPTT 50-70 seconds
Unfractionated Heparin
Unfractionated heparin protocol with target anti-Xa of 0.3-0.5 IU/mL
Unfractionated heparin
Unfractionated Heparin protocol with target anti-Xa of 0.3-0.5 IU/mL
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Unfractionated heparin
Unfractionated Heparin protocol with target anti-Xa of 0.3-0.5 IU/mL
Bivalirudin
Bivalirudin protocol with target aPTT 50-70 seconds
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Age: 18 years or older
* Ability to randomise the patient within 4 hours of ECMO support initiation
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sydney Local Health District
OTHER_GOV
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Royal Prince Alfred Hospital
Sydney, New South Wales, Australia
Countries
Review the countries where the study has at least one active or historical site.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2023/ETH00443
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.