A statistical analysis protocol for the time-differentiated target temperature management after out-of-hospital cardiac arrest (TTH48) clinical trial

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Kirkegaard , H , Pedersen , A R , Pettilä , V , Hjort , J , Rasmussen , B S , de Haas , I , Nielsen , J F , Ilkjaer , S , Kaltoft , A , Jeppesen , A N , Grejs , A M , Duez , C H V , Larsen , A I , Toome , V , Arus , U , Taccone , F S , Storm , C , Laitio , T , Skrifvars , M & Soreide , E 2016 , ' A statistical analysis protocol for the time-differentiated target temperature management after out-of-hospital cardiac arrest (TTH48) clinical trial ' , Scandinavian Journal of Trauma, Resuscitation and Emergency Medicine , vol. 24 , 138 . https://doi.org/10.1186/s13049-016-0334-0

Title: A statistical analysis protocol for the time-differentiated target temperature management after out-of-hospital cardiac arrest (TTH48) clinical trial
Author: Kirkegaard, Hans; Pedersen, Asger Roer; Pettilä, Ville; Hjort, Jakob; Rasmussen, Bodil Steen; de Haas, Inge; Nielsen, Jorgen Feldbaek; Ilkjaer, Susanne; Kaltoft, Anne; Jeppesen, Anni Norgaard; Grejs, Anders Morten; Duez, Christophe Henri Valdemar; Larsen, Alf Inge; Toome, Valdo; Arus, Urmet; Taccone, Fabio Silvio; Storm, Christian; Laitio, Timo; Skrifvars, Markus; Soreide, Eldar
Contributor: University of Helsinki, Clinicum
University of Helsinki, Clinicum
Date: 2016-11-28
Language: eng
Number of pages: 8
Belongs to series: Scandinavian Journal of Trauma, Resuscitation and Emergency Medicine
ISSN: 1757-7241
URI: http://hdl.handle.net/10138/173797
Abstract: Background: The TTH48 trial aims to determine whether prolonged duration (48 hours) of targeted temperature management (TTM) at 33 (+/- 1) degrees C results in better neurological outcomes compared to standard duration (24 hours) after six months in comatose out-of-hospital cardiac arrest (OHCA) patients. Methods: TTH48 is an investigator-initiated, multicentre, assessor-blinded, randomised, controlled superiority trial of 24 and 48 hours of TTM at 33 (+/- 1) degrees C performed in 355 comatose OHCA patients aged 18 to 80 years who were admitted to ten intensive care units (ICUs) in six Northern European countries. The primary outcome of the study is the Cerebral Performance Category (CPC) score observed at six months after cardiac arrest. CPC scores of 1 and 2 are defined as good neurological outcomes, and CPC scores of 3, 4 and 5 are defined as poor neurological outcomes. The secondary outcomes are as follows: mortality within six months after cardiac arrest, CPC at hospital discharge, Glasgow Coma Scale (GCS) score on day 4, length of stay in ICU and at hospital and the presence of any adverse events such as cerebral, circulatory, respiratory, gastrointestinal, renal, metabolic measures, infection or bleeding. With the planned sample size, we have 80% power to detect a 15% improvement in good neurological outcomes at a two-sided statistical significance level of 5%. Discussion: We present a detailed statistical analysis protocol (SAP) that specifies how primary and secondary outcomes should be evaluated. We also predetermine covariates for adjusted analyses and pre-specify sub-groups for sensitivity analyses. This pre-planned SAP will reduce analysis bias and add validity to the findings of this trial on the effect of length of TTM on important clinical outcomes after cardiac arrest.
Subject: Cardiac arrest
Heart arrest
Out-of-hospital
Targeted temperature management
Cerebral performance category
Mortality
Critical care
Intensive care
Randomised controlled trial
RESUSCITATION
HYPOTHERMIA
3126 Surgery, anesthesiology, intensive care, radiology
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