A statistical analysis protocol for the time-differentiated target temperature management after out-of-hospital cardiac arrest (TTH48) clinical trial
| Autor: | Timo Laitio, Anders Morten Grejs, Susanne Ilkjær, Markus B. Skrifvars, Fabio Silvio Taccone, Valdo Toome, Inge de Haas, Christophe Henri Valdemar Duez, Jakob Hjort, Anni Nørgaard Jeppesen, Anne Kaltoft, Asger Roer Pedersen, Jørgen Feldbæk Nielsen, Bodil Steen Rasmussen, Ville Pettilä, Christian Storm, Urmet Arus, Alf Inge Larsen, Eldar Søreide, Hans Kirkegaard |
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| Přispěvatelé: | Clinicum, Anestesiologian yksikkö, Department of Diagnostics and Therapeutics |
| Jazyk: | angličtina |
| Rok vydání: | 2016 |
| Předmět: |
Male
Time Factors Soins intensifs réanimation medicine.medical_treatment 030204 cardiovascular system & hematology Targeted temperature management Critical Care and Intensive Care Medicine 600 Technik Medizin angewandte Wissenschaften::610 Medizin und Gesundheit Body Temperature law.invention Study Protocol Cerebral performance category 0302 clinical medicine Randomized controlled trial Hypothermia Induced law Single-Blind Method 030212 general & internal medicine Out-of-hospital Aged 80 and over Randomised controlled trial RESUSCITATION Temperature Middle Aged Cardiac arrest 3. Good health Europe Survival Rate Emergency Medicine Female Adult medicine.medical_specialty Adolescent 610 Medicine & health Young Adult 03 medical and health sciences Statistical significance Intensive care medicine Humans Cardiopulmonary resuscitation Mortality Survival rate Aged HYPOTHERMIA business.industry Glasgow Coma Scale Médecine pathologie humaine Heart arrest 3126 Surgery anesthesiology intensive care radiology Cardiopulmonary Resuscitation Surgery Clinical trial Critical care Emergency medicine business Out-of-Hospital Cardiac Arrest |
| Zdroj: | Kirkegaard, H, Pedersen, A R, Pettilä, V, Hjort, J, Rasmussen, B S, de Haas, I, Nielsen, J F, Ilkjær, S, Kaltoft, A, Jeppesen, A N, Grejs, A M, Duez, C H V, Larsen, A I, Toome, V, Arus, U, Taccone, F S, Storm, C, Laitio, T, Skrifvars, M B & Søreide, E 2016, ' A statistical analysis protocol for the time-differentiated target temperature management after out-of-hospital cardiac arrest (TTH48) clinical trial ', Scandinavian Journal of Trauma, Resuscitation and Emergency Medicine, vol. 24, no. 1, pp. 138 . https://doi.org/10.1186/s13049-016-0334-0 Kirkegaard, Hans; Pedersen, Asger Roer; Pettilä, Ville Yrjö Olavi; Hjort, Jakob; Rasmussen, Bodil Steen; de Haas, Inge; Nielsen, Jørgen Feldbæk; Ilkjær, Susanne; Kaltoft, Anne; Jeppesen, Anni Nørgaard; Grejs, Anders Morten; Duez, Christophe Henri Valdemar; Larsen, Alf Inge; Toome, Valdo; Arus, Urmet; Taccone, Fabio Silvio; Storm, Christian; Laitio, Timo; Skrifvars, Markus B and Søreide, Eldar (2016). A statistical analysis protocol for the time-differentiated target temperature management after out-of-hospital cardiac arrest (TTH48) clinical trial. Scandinavian journal of trauma, resuscitation and emergency medicine, 24(1), p. 138. BioMed Central 10.1186/s13049-016-0334-0 Scandinavian Journal of Trauma, Resuscitation and Emergency Medicine, 24 (1 Scandinavian Journal of Trauma, Resuscitation and Emergency Medicine |
| DOI: | 10.1186/s13049-016-0334-0 |
| Popis: | 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 SCOPUS: ar.j info:eu-repo/semantics/published |
| Databáze: | OpenAIRE |
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