Detailed statistical analysis plan for the target temperature management after out-of-hospital cardiac arrest trial
Nielsen, Niklas LU ; Winkel, Per ; Cronberg, Tobias LU ; Erlinge, David LU
; Friberg, Hans
LU
; Gasche, Yvan
; Hassager, Christian
; Horn, Janneke
; Hovdenes, Jan
and Kjaergaard, Jesper
, et al.
(2013)
In Trials
14.
- Abstract
- Background: Animal experimental studies and previous randomized trials suggest an improvement in mortality and neurological function with temperature regulation to hypothermia after cardiac arrest. According to a systematic review, previous trials were small, had a risk of bias, evaluated select populations, and did not treat hyperthermia in the control groups. The optimal target temperature management (TTM) strategy is not known. To prevent outcome reporting bias, selective reporting and data-driven results, we present the a priori defined detailed statistical analysis plan as an update to the previously published outline of the design and rationale for the TTM trial. Methods: The TTM trial is an investigator-initiated, multicenter,... (More)
- Background: Animal experimental studies and previous randomized trials suggest an improvement in mortality and neurological function with temperature regulation to hypothermia after cardiac arrest. According to a systematic review, previous trials were small, had a risk of bias, evaluated select populations, and did not treat hyperthermia in the control groups. The optimal target temperature management (TTM) strategy is not known. To prevent outcome reporting bias, selective reporting and data-driven results, we present the a priori defined detailed statistical analysis plan as an update to the previously published outline of the design and rationale for the TTM trial. Methods: The TTM trial is an investigator-initiated, multicenter, international, randomized, parallel-group, and assessor-blinded clinical trial of temperature management in 950 adult unconscious patients resuscitated after out-of-hospital cardiac arrest of a presumed cardiac cause. The patients are randomized to a TTM of either 33 degrees C or 36 degrees C after return of spontaneous circulation. The primary outcome is all-cause mortality at maximal follow-up (until end of the trial and a minimum of 180 days). The main secondary outcomes are the composite outcome of all-cause mortality and poor neurological function (Cerebral Performance Category (CPC) 3 and 4, and modified Rankin Scale (mRS) 4 and 5) at hospital discharge and at 180 days; and assessment of safety and harm: bleeding, infections, electrolyte and metabolic disorders, seizures, cardiac arrhythmia, and renal replacement therapy. Conclusion: The TTM trial investigates potential benefit and harm of two target temperature strategies, both avoiding hyperthermia in a large proportion of the out-of-hospital cardiac arrest population. (Less)
Please use this url to cite or link to this publication:
https://lup.lub.lu.se/record/4098926
- author
- Nielsen, Niklas
LU
; Winkel, Per
; Cronberg, Tobias
LU
; Erlinge, David
LU
; Friberg, Hans
LU
; Gasche, Yvan
; Hassager, Christian
; Horn, Janneke
; Hovdenes, Jan
and Kjaergaard, Jesper
, et al. (More)
- Nielsen, Niklas
LU
; Winkel, Per
; Cronberg, Tobias
LU
; Erlinge, David
LU
; Friberg, Hans
LU
; Gasche, Yvan
; Hassager, Christian
; Horn, Janneke
; Hovdenes, Jan
; Kjaergaard, Jesper
; Kuiper, Michael
; Pellis, Tommaso
; Stammet, Pascal
; Wanscher, Michael
; Wise, Matt P.
; Aneman, Anders
and Wetterslev, Jorn
(Less)
- organization
- publishing date
- 2013
- type
- Contribution to journal
- publication status
- published
- subject
- keywords
- Cardiac arrest, Induced hypothermia, Mortality, Neurological function, Targeted temperature management, Randomized clinical trial, Statistical, analysis plan
- in
- Trials
- volume
- 14
- article number
- 300
- publisher
- BioMed Central (BMC)
- external identifiers
-
- wos:000324857100001
- scopus:84883892607
- pmid:24044764
- ISSN
- 1745-6215
- DOI
- 10.1186/1745-6215-14-300
- language
- English
- LU publication?
- yes
- id
- fde4b219-0cd2-47f7-bb22-e1969a7fa0e5 (old id 4098926)
- date added to LUP
- 2016-04-01 14:50:59
- date last changed
- 2022-01-28 02:53:20
@article{fde4b219-0cd2-47f7-bb22-e1969a7fa0e5,
abstract = {{Background: Animal experimental studies and previous randomized trials suggest an improvement in mortality and neurological function with temperature regulation to hypothermia after cardiac arrest. According to a systematic review, previous trials were small, had a risk of bias, evaluated select populations, and did not treat hyperthermia in the control groups. The optimal target temperature management (TTM) strategy is not known. To prevent outcome reporting bias, selective reporting and data-driven results, we present the a priori defined detailed statistical analysis plan as an update to the previously published outline of the design and rationale for the TTM trial. Methods: The TTM trial is an investigator-initiated, multicenter, international, randomized, parallel-group, and assessor-blinded clinical trial of temperature management in 950 adult unconscious patients resuscitated after out-of-hospital cardiac arrest of a presumed cardiac cause. The patients are randomized to a TTM of either 33 degrees C or 36 degrees C after return of spontaneous circulation. The primary outcome is all-cause mortality at maximal follow-up (until end of the trial and a minimum of 180 days). The main secondary outcomes are the composite outcome of all-cause mortality and poor neurological function (Cerebral Performance Category (CPC) 3 and 4, and modified Rankin Scale (mRS) 4 and 5) at hospital discharge and at 180 days; and assessment of safety and harm: bleeding, infections, electrolyte and metabolic disorders, seizures, cardiac arrhythmia, and renal replacement therapy. Conclusion: The TTM trial investigates potential benefit and harm of two target temperature strategies, both avoiding hyperthermia in a large proportion of the out-of-hospital cardiac arrest population.}},
author = {{Nielsen, Niklas and Winkel, Per and Cronberg, Tobias and Erlinge, David and Friberg, Hans and Gasche, Yvan and Hassager, Christian and Horn, Janneke and Hovdenes, Jan and Kjaergaard, Jesper and Kuiper, Michael and Pellis, Tommaso and Stammet, Pascal and Wanscher, Michael and Wise, Matt P. and Aneman, Anders and Wetterslev, Jorn}},
issn = {{1745-6215}},
keywords = {{Cardiac arrest; Induced hypothermia; Mortality; Neurological function; Targeted temperature management; Randomized clinical trial; Statistical; analysis plan}},
language = {{eng}},
publisher = {{BioMed Central (BMC)}},
series = {{Trials}},
title = {{Detailed statistical analysis plan for the target temperature management after out-of-hospital cardiac arrest trial}},
url = {{https://lup.lub.lu.se/search/files/4198330/4254926}},
doi = {{10.1186/1745-6215-14-300}},
volume = {{14}},
year = {{2013}},
}