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RECRUITING
NCT05959252
PHASE2

BivaLirudin versUS Heparin in Extracorporeal Membrane Oxygenation

Sponsor: Sydney Local Health District

View on ClinicalTrials.gov

Summary

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.

Official title: BivaLirudin versUS Heparin in ECMO - A Registry-embedded, Randomised, Open Label, Feasibility Trial Comparing Two Anticoagulation Strategies in Patients on Extracorporeal Membrane Oxygenation (ECMO)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2024-05-01

Completion Date

2026-05-01

Last Updated

2024-08-13

Healthy Volunteers

No

Interventions

DRUG

Unfractionated heparin

Unfractionated Heparin protocol with target anti-Xa of 0.3-0.5 IU/mL

DRUG

Bivalirudin

Bivalirudin protocol with target aPTT 50-70 seconds

Locations (1)

Royal Prince Alfred Hospital

Sydney, New South Wales, Australia