Objekt-Metadaten

A statistical analysis protocol for the time-differentiated target temperature management after out-of-hospital cardiac arrest (TTH48) clinical trial
Kirkegaard, Hans ;  Pedersen, Asger Roer ;  Pettila, Ville ;  Hjort, Jakob ;  Rasmussen, Bodil Steen ;  de Haas, Inge ;  Storm, Christian [u.v.m.]

HaupttitelA statistical analysis protocol for the time-differentiated target temperature management after out-of-hospital cardiac arrest (TTH48) clinical trial
AutorKirkegaard, Hans
AutorPedersen, Asger Roer
AutorPettila, Ville
AutorHjort, Jakob
AutorRasmussen, Bodil Steen
Autorde Haas, Inge
AutorStorm, Christian [u.v.m.]
Seitenzahl8 S.
Freie SchlagwörterCardiac arrest; Heart arrest; Out-of-hospital; Targeted temperature management; Cerebral performance category; Mortality; Critical care; Intensive care; Randomised controlled trial
DDC610 Medizin und Gesundheit
Auch erschienen inScandinavian Journal of Trauma, Resuscitation and Emergency Medicine. - 24 (2016), Artikel Nr. 138
ZusammenfassungBackground

The TTH48 trial aims to determine whether prolonged duration (48 hours) of targeted temperature management (TTM) at 33 (±1) °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) ° 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.

Trial registration

ClinicalTrials.gov: NCT01689077, 17 September 2012
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Fachbereich/EinrichtungMedizinische Fakultät Charité - Universitätsmedizin Berlin
Erscheinungsjahr2016
Dokumententyp/-SammlungenWissenschaftlicher Artikel
SpracheEnglisch
RechteCreative Commons License
This work is licensed under a Creative Commons Attribution 4.0 International License.
Anmerkungen des AutorsDer Artikel wurde in einer reinen Open-Access-Zeitschrift publiziert.
Erstellt am06.02.2017 - 10:48:25
Letzte Änderung06.02.2017 - 10:52:29
 
Statische URLhttp://edocs.fu-berlin.de/docs/receive/FUDOCS_document_000000026272
DOI10.1186/s13049-016-0334-0
Zugriffsstatistik
 

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