dc.contributor.author
Kirkegaard, Hans
dc.contributor.author
Pedersen, Asger Roer
dc.contributor.author
Pettila, Ville
dc.contributor.author
Hjort, Jakob
dc.contributor.author
Rasmussen, Bodil Steen
dc.contributor.author
de Haas, Inge
dc.contributor.author
Storm, Christian [u.v.m.]
dc.date.accessioned
2018-06-08T10:51:58Z
dc.date.available
2017-02-06T10:52:29.018Z
dc.identifier.uri
https://refubium.fu-berlin.de/handle/fub188/21240
dc.identifier.uri
http://dx.doi.org/10.17169/refubium-24535
dc.description.abstract
Background 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
en
dc.rights.uri
http://creativecommons.org/licenses/by/4.0/
dc.subject
Cardiac arrest
dc.subject
Out-of-hospital
dc.subject
Targeted temperature management
dc.subject
Cerebral performance category
dc.subject
Intensive care
dc.subject
Randomised controlled trial
dc.subject.ddc
600 Technik, Medizin, angewandte Wissenschaften::610 Medizin und Gesundheit
dc.title
A statistical analysis protocol for the time-differentiated target temperature
management after out-of-hospital cardiac arrest (TTH48) clinical trial
dc.type
Wissenschaftlicher Artikel
dcterms.bibliographicCitation
Scandinavian Journal of Trauma, Resuscitation and Emergency Medicine. - 24
(2016), Artikel Nr. 138
dcterms.bibliographicCitation.doi
10.1186/s13049-016-0334-0
dcterms.bibliographicCitation.url
http://sjtrem.biomedcentral.com/articles/10.1186/s13049-016-0334-0
refubium.affiliation
Charité - Universitätsmedizin Berlin
de
refubium.mycore.fudocsId
FUDOCS_document_000000026272
refubium.note.author
Der Artikel wurde in einer reinen Open-Access-Zeitschrift publiziert.
refubium.resourceType.isindependentpub
no
refubium.mycore.derivateId
FUDOCS_derivate_000000007632
dcterms.accessRights.openaire
open access