BivaLirudin versUS Heparin in Extracorporeal Membrane Oxygenation
Launched by SYDNEY LOCAL HEALTH DISTRICT · Jul 16, 2023
Trial Information
Current as of July 22, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying two different medications, Bivalirudin and Heparin, which are used to prevent blood clots in patients receiving a treatment called extracorporeal membrane oxygenation (ECMO). ECMO is a life-support technique that helps patients whose hearts or lungs are not working properly. The main goal of the trial is to find out which medication works better for keeping blood thin enough to prevent complications, while also looking at the risks of bleeding and clotting, and comparing the costs of both treatments.
To participate in this study, patients need to be at least 18 years old and currently receiving ECMO support. However, certain patients may not be eligible, such as those who have recently had heart surgery, have specific bleeding disorders, or are pregnant. If someone joins the study, they will be randomly assigned to receive either Bivalirudin or Heparin. This trial is currently recruiting participants, and it aims to help improve the care of patients on ECMO by finding out which blood thinner is more effective and safer.
Gender
ALL
Eligibility criteria
- • 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
About Sydney Local Health District
Sydney Local Health District (SLHD) is a leading healthcare organization dedicated to providing high-quality medical services and advancing health research in the Sydney region. As a prominent sponsor of clinical trials, SLHD focuses on innovative treatments and evidence-based practices to improve patient outcomes. With a commitment to ethical standards and patient safety, SLHD collaborates with healthcare professionals, researchers, and academic institutions to facilitate groundbreaking studies that contribute to the global medical community. Its comprehensive approach ensures that clinical trials are conducted efficiently, fostering advancements in healthcare that benefit both local and broader populations.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Sydney, New South Wales, Australia
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported