ANZICS CTG Endorsed Study
TAME Cardiac Arrest
Targeted therapeutic mild hypercapnia after resuscitated cardiac arrest: A phase III multi-centre randomised controlled trial
Study Description
The TAME Cardiac Arrest trial will study the ability of higher carbon dioxide (CO2) levels to reduce brain damage, comparing giving patients ‘normal’ to ‘slightly higher than normal’ blood CO2 levels and assessing their ability to return to normal life-tasks. It will be the largest trial ever conducted in heart attack patients in the ICU. This therapy is cost free and, if shown to be effective, will improve thousands of Australian lives, transform clinical practice, and yield major savings.
Management Committee
Glenn Eastwood (Chair), John Archer, Rinaldo Bellomo, Stephen Bernard, Carol Hodgson, Shay McGuinness, Alistair Nichol, Niklas Nielsen, Rachael Parke, Markus Skrifvars, Dion Stub, Fabio Taccone.
Project Manager
Bridget Ady (TAME Project Manager, ANZIC RC)
Kate Ainscough (TAME Project Manager, ICCTN, Ireland)
Administering Institution
ANZIC-Research Centre, Monash University
Collaborators
Irish Critical Care – Clinical Trials Group
Sample Size
1700 patients
Funding
National Health & Medical Research Council
Irish Health Research Board
Project Status as of June 2019
Phase
Actively recruiting in multiple regions and countries with 30 sites in Australia, Denmark, New Zealand, Ireland, Norway, Finland, Saudi Arabia and Slovenia.
Recruitment to date
261 patients have been enrolled as of the 30th June, 2019 – 15% of the target 1700 patients.
Co-enrolment with the TTM2 trial is occurring in many, but not all sites – 98 co-enrolled patients to date. Approximately 275 patients are likely to be co-enrolled by the time the TTM2 trial finished recruitment (anticipated to occur in January 2020).
Trial Management
The TAME management and steering committee have expanded to include personnel with appropriate skill and expertise in trial coordinator and oversight from the perspective of Monash University requirements.
Protocol development
A single protocol amendment was approved in December 2018. This protocol amendment was to enable sites to send identified patient contact information directly to Monash University to enable central follow-up.
Funding
Funding applications remain in place with NHMRC and the Irish Health Research Board. Application outcomes for project grants with the New Zealand HRC; the Canadian CIHR; and, Singaporean government are not yet known.
Site commencement pending
Planned additional sites will be commenced in the next 3-4 months in the following countries: France, Italy, Switzerland, Sweden, Czech Republic and The Netherlands. An initial expression of interest to date has resulted in 12 sites from ANZ being received.
Reference
CTG1617-001
ANZCTR: ACTRN12617000036314
Contact
Glenn Eastwood (email)