ANZICS CTG Endorsed Study
A randomised controlled trial of a heparin low dose protocol versus therapeutic dose heparin in patients on veno-venous extra corporeal membrane oxygenation
HELP-ECMO is an Australian-initiated, 230-patient, multicentre, randomised, controlled, parallel-group, assessor-blinded clinical trial designed to determine if low dose heparin during treatment with VV-ECMO when compared with standard care (therapeutic anticoagulation) reduces the proportion of patients experiencing major bleeding. The trial is a two-sided superiority trial that will randomly allocate VV-ECMO patients to low dose heparin or standard care in a 1:1 ratio.
Patients will be eligible if they fulfil all of the inclusion and none of the exclusion criteria: Inclusion criteria: Intensive care patients who require VV-ECMO
The primary outcome is the proportion of patients who experience major bleeding. Secondary outcomes include thrombosis, mortality, blood product requirements, length of stay and health status using the EQ5D.
Zoe McQuilten (Chair), Cecile Aubron, Michael Bailey, Jamie Cooper, John Fraser, Carol Hodgson, Vincent Pellegrino, David Pilcher, Huyen Tran, and Shirley Vallance.
Project Status as of June 2019
The pilot study – HELP-ECMO – has been published in Critical Care Medicine in 2019.
We are actively reviewing the proposed study design and potential funding sources and will reapply for ANZICS CTG endorsement.
Zoe McQuilten (email)