BivaLirudin versUS Heparin in Extracorporeal Membrane Oxygenation
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSydney Local Health District
About this trial
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.
Eligibility criteria
Qualifiers
Patients receiving ECMO
Age: 18 years or older
Ability to randomise the patient within 4 hours of ECMO support initiation
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Unfractionated heparin
- Bivalirudin
Treatment groups
80 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov