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BivaLirudin versUS Heparin in Extracorporeal Membrane Oxygenation

NCT05959252 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-05-08

No results posted yet for this study

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.

Conditions

  • Extracorporeal Membrane Oxygenation Complication

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

Sponsors & Collaborators

  • Sydney Local Health District

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-01
Primary Completion
2026-06-01
Completion
2026-09-01

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05959252 on ClinicalTrials.gov