Comparing Bivalirudin and Heparin for Anticoagulation in ECMO Patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label randomized clinical trial aims to compare the effectiveness of Bivalirudin versus Unfractionated Heparin for anticoagulation in patients requiring extracorporeal membrane oxygenation (ECMO). The study will assess the ability to maintain anticoagulation within a defined therapeutic range, as well as the incidence of bleeding and thrombotic complications. Additionally, it will evaluate the total cost associated with each anticoagulation method. Participants will be randomly assigned to receive either Bivalirudin or Heparin within four hours of ECMO support initiation.

Why it matters

Who can join: the full rules

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

Where it's running

• Royal Prince Alfred Hospital
  Sydney, New South Wales, Australia Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.