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Detailed statistica...
Detailed statistical analysis plan for the target temperature management after out-of-hospital cardiac arrest trial
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- Nielsen, Niklas (author)
- Lund University,Lunds universitet,Anestesiologi och intensivvård,Sektion II,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Anesthesiology and Intensive Care,Section II,Department of Clinical Sciences, Lund,Faculty of Medicine
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Winkel, Per (author)
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- Cronberg, Tobias (author)
- Lund University,Lunds universitet,Neurologi, Lund,Sektion IV,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Neurology, Lund,Section IV,Department of Clinical Sciences, Lund,Faculty of Medicine
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- Erlinge, David (author)
- Lund University,Lunds universitet,Kardiologi,Sektion II,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Cardiology,Section II,Department of Clinical Sciences, Lund,Faculty of Medicine
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- Friberg, Hans (author)
- Lund University,Lunds universitet,Anestesiologi och intensivvård,Sektion II,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Anesthesiology and Intensive Care,Section II,Department of Clinical Sciences, Lund,Faculty of Medicine
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Gasche, Yvan (author)
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Hassager, Christian (author)
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Horn, Janneke (author)
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Hovdenes, Jan (author)
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Kjaergaard, Jesper (author)
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Kuiper, Michael (author)
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Pellis, Tommaso (author)
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Stammet, Pascal (author)
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Wanscher, Michael (author)
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Wise, Matt P. (author)
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Aneman, Anders (author)
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Wetterslev, Jorn (author)
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(creator_code:org_t)
- Springer Science and Business Media LLC, 2013
- 2013
- English.
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In: Trials. - : Springer Science and Business Media LLC. - 1745-6215. ; 14
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https://doi.org/10.1...
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Abstract
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- 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.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Kardiologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Cardiac and Cardiovascular Systems (hsv//eng)
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Neurologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Neurology (hsv//eng)
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Anestesi och intensivvård (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Anesthesiology and Intensive Care (hsv//eng)
Keyword
- Cardiac arrest
- Induced hypothermia
- Mortality
- Neurological function
- Targeted temperature management
- Randomized clinical trial
- Statistical
- analysis plan
Publication and Content Type
- art (subject category)
- ref (subject category)
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- By the author/editor
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Nielsen, Niklas
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Winkel, Per
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Cronberg, Tobias
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Erlinge, David
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Friberg, Hans
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Gasche, Yvan
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show more...
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Hassager, Christ ...
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Horn, Janneke
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Hovdenes, Jan
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Kjaergaard, Jesp ...
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Kuiper, Michael
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Pellis, Tommaso
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Stammet, Pascal
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Wanscher, Michae ...
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Wise, Matt P.
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Aneman, Anders
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Wetterslev, Jorn
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show less...
- About the subject
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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and Neurology
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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and Anesthesiology a ...
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Trials
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Lund University