Health TrialsbyHealthPanel

BivaLirudin versUS Heparin in Extracorporeal Membrane Oxygenation

ConditionExtracorporeal Membrane Oxygenation Complication
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Unfractionated heparin

    Drug

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

  • Bivalirudin

    Drug

    Bivalirudin protocol with target aPTT 50-70 seconds

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: BivalirudinActive comparator 1 intervention
Group B: Unfractionated HeparinActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Time in therapeutic range

Proportion of monitoring samples within therapeutic range

Time frame
30 days

Secondary outcomes

1

Enrolment rate

Enrolment rate

Time frame
30 days
2

Reasons for non-enrolment

Reasons for non-enrolment of eligible patients into the study

Time frame
30 days
3

Crossover between arms

The number of cross over patients between arms of the study

Time frame
30 days
4

Circuit changes

The number of circuit changes and length of circuit life

Time frame
30 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sydney Local Health District

Lead sponsor

Source ClinicalTrials.gov
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