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BackgroundLess than 500 participants have been included in randomized trials comparing hypothermia with regular care for out-of-hospital cardiac arrest patients, and many of these trials were small and at a high risk of bias. Consequently, the accrued data on this potentially beneficial intervention resembles that of a drug following small phase II trials. A large confirmatory trial is therefore warranted.MethodsThe TTM2-trial is an international, multicenter, parallel group, investigator-initiated, randomized, superiority trial in which a target temperature of 33°C after cardiac arrest will be compared with a strategy to maintain normothermia and early treatment of fever (≥37.8°C). Participants will be randomized within 3 hours of return of spontaneous circulation with the intervention period lasting 40 hours in both groups. Sedation will be mandatory for all patients throughout the intervention period. The clinical team involved with direct patient care will not be blinded to allocation group due to the inherent difficulty in blinding the intervention. Prognosticators, outcome-assessors, the steering group, the trial coordinating team, and trial statistician will be blinded. The primary outcome will be all-cause mortality at 180 days after randomization. We estimate a 55% mortality in the control group. To detect an absolute risk reduction of 7.5% with an alpha of 0.05 and 90% power, 1900 participants will be enrolled. The main secondary neurological outcome will be poor functional outcome (modified Rankin Scale 4-6) at 180 days after arrest.DiscussionThe TTM2-trial will compare hypothermia to 33°C with normothermia and early treatment of fever (≥37.8°C) after out-of-hospital cardiac arrest.

Original publication

DOI

10.1016/j.ahj.2019.06.012

Type

Journal

American heart journal

Publication Date

11/2019

Volume

217

Pages

23 - 31

Addresses

Lund University, Skåne University Hospital, Department of Clinical Sciences, Cardiology, Lund, Sweden. Electronic address: josef.dankiewicz@med.lu.se.

Keywords

Humans, Fever, Body Temperature, Hypothermia, Induced, Cause of Death, Sample Size, Time Factors, Multicenter Studies as Topic, Randomized Controlled Trials as Topic, Out-of-Hospital Cardiac Arrest, Equivalence Trials as Topic, Outcome Assessment, Health Care