inner-banner

TTM2 Trial

ANZICS CTG Supported Study

TTM2 Trial

Targeted hypothermia versus targeted normothermia after out-of-hospital cardiac arrest 2, a randomised clinical trial

Study Description

The TTM2 trial is a continuation of the collaboration that resulted in the previous Target Temperature Management after out-of-hospital cardiac arrest trial (hereafter: TTM1). The TTM2 trial is an international, multicentre, parallel group, non-commercial, randomized superiority trial in which a target temperature of 33°C after cardiac arrest will be compared with normothermia and early treatment of fever (≥37.8°C). Patients eligible for inclusion will be unconscious adult patients with out-of-hospital cardiac arrest of a presumed cardiac cause with stable return of spontaneous circulation. Rapid cooling in the hypothermia group will be achieved by means of cold fluids and state-of-the-art cooling devices (intravascular/body-surface/nasal/oesophageal: A closed loop system will be used to maintain the target temperature). In the normothermia arm the aim will be early treatment of fever (≥37.8°C) using pharmacological measures and physical cooling when needed. For participants who develop a temperature of 37.8°C (trigger), a device will be used and set at 37.5°C. Participants who remain unconscious will be assessed according to a conservative protocol based on the European Resuscitation Council (ERC)’s recommendations for neurological prognostication after cardiac arrest. Follow-up will be performed at 30 days, 6 and 24 months after cardiac arrest. The main results of the trial will be published following the 6-month follow-up, results from the long-term follow-up will be presented separately.

Management Committee

Manoj Saxena (Chair), Anders Åneman, Frances Bass (Project Manager), Rinaldo Bellomo, Glenn Eastwood, Naomi Hammond, John Myburgh, Parisa Glass, Colman Taylor, and Niklas Nielsen.

Administering Institution

The George Institute for Global Health, University of NSW, Sydney

Collaborators

Lund University

Sample Size

1900 patients

Funding

The Swedish Research Council – Grant Nr:2016-00428 $AUD 3,247,977.00
The Swedish Heart-Lung Foundation $AUD 463,957.00
Stig and Ragna Gorthon Foundation $AUD 154,652.00
Knutsson Foundation $AUD 154,652.00.

Project Status as of June 2018

NMA HREC approval has been gained.

12 confirmed Australian sites participating.

Investigator start up meeting planned for Australian sites 14th June 2018.

Contact

Manoj Saxena (mail)
Frances Bass (mail)

Reference

CTG1617-08
NCT02908308