Time-differentiated target temperature management after out-of-hospital cardiac arrest : a multicentre, randomised, parallel-group, assessor-blinded clinical trial (the TTH48 trial): study protocol for a randomised controlled trial

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Kirkegaard , H , Rasmussen , B S , de Haas , I , Nielsen , J F , Ilkjaer , S , Kaltoft , A , Jeppesen , A N , Grejs , A , Duez , C H V , Larsen , A I , Pettila , V , Toome , V , Arus , U , Taccone , F S , Storm , C , Skrifvars , M & Soreide , E 2016 , ' Time-differentiated target temperature management after out-of-hospital cardiac arrest : a multicentre, randomised, parallel-group, assessor-blinded clinical trial (the TTH48 trial): study protocol for a randomised controlled trial ' , Trials , vol. 17 , 228 . https://doi.org/10.1186/s13063-016-1338-9

Title: Time-differentiated target temperature management after out-of-hospital cardiac arrest : a multicentre, randomised, parallel-group, assessor-blinded clinical trial (the TTH48 trial): study protocol for a randomised controlled trial
Author: Kirkegaard, Hans; Rasmussen, Bodil S.; de Haas, Inge; Nielsen, Jorgen Feldbaek; Ilkjaer, Susanne; Kaltoft, Anne; Jeppesen, Anni Norregaard; Grejs, Anders; Duez, Christophe Henri Valdemar; Larsen, Alf Inge; Pettila, Ville; Toome, Valdo; Arus, Urmet; Taccone, Fabio Silvio; Storm, Christian; Skrifvars, Markus; Soreide, Eldar
Contributor: University of Helsinki, Clinicum
University of Helsinki, Clinicum
Date: 2016-05-04
Language: eng
Number of pages: 9
Belongs to series: Trials
ISSN: 1745-6215
URI: http://hdl.handle.net/10138/163045
Abstract: Background: The application of therapeutic hypothermia (TH) for 12 to 24 hours following out-of-hospital cardiac arrest (OHCA) has been associated with decreased mortality and improved neurological function. However, the optimal duration of cooling is not known. We aimed to investigate whether targeted temperature management (TTM) at 33 +/- 1 degrees C for 48 hours compared to 24 hours results in a better long-term neurological outcome. Methods: The TTH48 trial is an investigator-initiated pragmatic international trial in which patients resuscitated from OHCA are randomised to TTM at 33 +/- 1 degrees C for either 24 or 48 hours. Inclusion criteria are: age older than 17 and below 80 years; presumed cardiac origin of arrest; and Glasgow Coma Score (GCS) <8, on admission. The primary outcome is neurological outcome at 6 months using the Cerebral Performance Category score (CPC) by an assessor blinded to treatment allocation and dichotomised to good (CPC 1-2) or poor (CPC 3-5) outcome. Secondary outcomes are: 6-month mortality, incidence of infection, bleeding and organ failure and CPC at hospital discharge, at day 28 and at day 90 following OHCA. Assuming that 50 % of the patients treated for 24 hours will have a poor outcome at 6 months, a study including 350 patients (175/arm) will have 80 % power (with a significance level of 5 %) to detect an absolute 15 % difference in primary outcome between treatment groups. A safety interim analysis was performed after the inclusion of 175 patients. Discussion: This is the first randomised trial to investigate the effect of the duration of TTM at 33 +/- 1 degrees C in adult OHCA patients. We anticipate that the results of this trial will add significant knowledge regarding the management of cooling procedures in OHCA patients.
Subject: Out-of-hospital cardiac arrest
Target temperature management
Mild therapeutic hypothermia
Prolonged target temperature management
INTERNATIONAL LIAISON COMMITTEE
EUROPEAN-RESUSCITATION-COUNCIL
AMERICAN-HEART-ASSOCIATION
GLOBAL CEREBRAL-ISCHEMIA
THERAPEUTIC HYPOTHERMIA
MILD HYPOTHERMIA
COMATOSE SURVIVORS
STROKE-FOUNDATION
TASK-FORCE
STATEMENT
3126 Surgery, anesthesiology, intensive care, radiology
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