Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT05959252

BivaLirudin versUS Heparin in Extracorporeal Membrane Oxygenation

Led by Sydney Local Health District · Updated on 2026-05-08

80

Participants Needed

1

Research Sites

121 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

BivaLirudin versUS Heparin in Extracorporeal Membrane Oxygenation

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients receiving ECMO
  • Age 18 years or older
  • Ability to randomise the patient within 4 hours of ECMO support initiation
Not Eligible

You will not qualify if you...

  • Post-cardiotomy ECMO patients
  • Contraindication to heparin or bivalirudin at time of randomisation, such as active bleeding
  • Heparin induced thrombotic thrombocytopenia syndrome
  • Expected disconnection from ECMO within one day after cannulation
  • Limitations of care due to patient wishes or medical team decisions
  • Other reasons where the treating physician deems participation not in the patient's best interest
  • Suspected or confirmed pregnancy
  • Inherited bleeding or thrombotic disorders
  • Systemic Lupus Erythematosus patients

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Royal Prince Alfred Hospital

Sydney, New South Wales, Australia, 2050

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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BivaLirudin versUS Heparin in Extracorporeal Membrane Oxygenation | DecenTrialz