Target Temperature Management after out-of-hospital cardiac arrest—a randomized, parallel-group, assessor-blinded clinical trial—rationale and design

Niklas Nielsen, Jørn Wetterslev, Nawaf al-Subaie, Bertil Andersson, John Bro-Jeppesen, Gillian Bishop, Iole Brunetti, Julius Cranshaw, Tobias Cronberg, Kristin Edqvist, David Erlinge, Yvan Gasche, Guy Glover, Christian Hassager, Janneke Horn, Jan Hovdenes, Jesper Johnsson, Jesper Kjaergaard, Michael Kuiper, Jørund Langørgen, Lewis Macken, Louise Martinell, Patrik Martner, Thomas Pellis, Paolo Pelosi, Per Petersen, Stefan Persson, Malin Rundgren, Manoj Saxena, Robert Svensson, Pascal Stammet, Anders Thorén, Johan Undén, Andrew Walden, Jesper Wallskog, Michael Wanscher, Matthew P Wise, Nicholas Wyon, Anders Aneman, Hans Friberg
American Heart Journal 2012, 163 (4): 541-8

BACKGROUND: Experimental animal studies and previous randomized trials suggest an improvement in mortality and neurologic function with induced hypothermia after cardiac arrest. International guidelines advocate the use of a target temperature management of 32°C to 34°C for 12 to 24 hours after resuscitation from out-of-hospital cardiac arrest. A systematic review indicates that the evidence for recommending this intervention is inconclusive, and the GRADE level of evidence is low. Previous trials were small, with high risk of bias, evaluated select populations, and did not treat hyperthermia in the control groups. The optimal target temperature management strategy is not known.

METHODS: The TTM trial is an investigator-initiated, international, randomized, parallel-group, and assessor-blinded clinical trial designed to enroll at least 850 adult, unconscious patients resuscitated after out-of-hospital cardiac arrest of a presumed cardiac cause. The patients will be randomized to a target temperature management of either 33°C or 36°C after return of spontaneous circulation. In both groups, the intervention will last 36 hours. The primary outcome is all-cause mortality at maximal follow-up. The main secondary outcomes are the composite outcome of all-cause mortality and poor neurologic function (cerebral performance categories 3 and 4) at hospital discharge and at 180 days, cognitive status and quality of life at 180 days, assessment of safety and harm.

DISCUSSION: The TTM trial will investigate potential benefit and harm of 2 target temperature strategies, both avoiding hyperthermia in a large proportion of the out-of-hospital cardiac arrest population.

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