ANZICS CTG Endorsed Study

HELP-ECMO

A randomised controlled trial of a heparin low dose protocol versus therapeutic dose heparin in patients on veno-venous extra corporeal membrane oxygenation

Study Description

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

Exclusions:

  • Less than 16 years of age
  • Contra-indication to heparin (e.g. heparin induced thrombocytopenia)
  • Pre-existing indication for therapeutic anticoagulation (e.g. PE, intracardiac thrombus)
  • Contra-indication to therapeutic anticoagulation at the time of randomisation (e.g. active bleeding)
  • Greater than 48-hours ECMO support prior to enrolment
  • Treating clinician deems the study is not in the patient’s interest

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.

Management Committee

Zoe McQuilten (Chair), Cecile Aubron, Michael Bailey, Jamie Cooper, John Fraser, Carol Hodgson, Vincent Pellegrino, David Pilcher, Huyen Tran, and Shirley Vallance.

Administering Institution

Monash University

Sample Size

130 patients

Project Status as of June 2018

The trial has not yet commenced.

Reference

CTG1617-07

Contact

Zoe McQuilten (email)