title: Therapeutic temperature modulation in severe or moderate traumatic brain injury: a propensity score analysis of data from the Nationwide Japan Neurotrauma Data Bank.
abstract: OBJECTIVE
  In patients with severe traumatic brain injury (TBI), a randomized controlled trial revealed that outcomes did not significantly improve after therapeutic hypothermia (TH) or normothermia (TN). However, avoiding pyrexia, which is often associated with intracranial disorders, might improve clinical outcomes. The objective of this study was to compare neurological outcomes among patients with moderate and severe TBI after therapeutic temperature modulation (TTM) in the absence of other interventions.
  
  
  METHODS
  Data from 1091 patients were obtained from the Japan Neurotrauma Data Bank Project 2009, a cohort observational study. Patients with cardiac arrest, those with a Glasgow Coma Scale score of 3 and dilated fixed pupils, and those whose cause of death was injury to another area of the body were excluded, leaving 687 patients aged 16 years or older in this study. The patients were divided into 2 groups: the TTM group underwent TN (213 patients) or TH (82 patients), and the control group (392 patients) did not receive TTM. The primary end point for this study was the rate of poor outcome at hospital discharge, and the secondary end point was in-hospital death. Out of the 208 total items in the database, 29 variables that could potentially affect outcome were matched using the propensity score (PS) method in order to reduce selection bias and balance the baseline characteristics.
  
  
  RESULTS
  From each group, 141 patients were extracted using the PS-matching process. Among the patients in the TTM group, 29 had undergone TH and 112 had undergone TN. In a log-rank test using Kaplan-Meier survival curves, no significant differences in patient outcome or death were observed between the 2 groups (poor outcome, p = 0.83; death, p = 0.18). A Cox proportional-hazards regression analysis established the HR for poor outcome and mortality at 1.03 (95% CI 0.78-1.36, p = 0.83) and 1.34 (95% CI 0.87-2.07, p = 0.18), respectively.
  
  
  CONCLUSIONS
  There was no clear improvement in neurological outcomes after TTM in patients with moderate or severe TBI. To elucidate the role of TTM in patients with these injuries, a prospective study is needed with long-term follow-up using specific target temperatures.
authors.affiliation: Departments of 1 Emergency Medicine.|Neurosurgery, and.|Japan Neurotrauma Data Bank Committee, Japan Society of Neurotraumatology, Tokyo, Japan.
authors.forename: Kei
authors.initials: K
authors.lastname: Miyata
authors.affiliation: Public Health, Sapporo Medical University;
authors.forename: Hirofumi
authors.initials: H
authors.lastname: Ohnishi
authors.affiliation: Emergency and Critical Care Center, Hokkaido University Hospital, Sapporo; and.
authors.forename: Kunihiko
authors.initials: K
authors.lastname: Maekawa
authors.affiliation: Neurosurgery, and.
authors.forename: Takeshi
authors.initials: T
authors.lastname: Mikami
authors.affiliation: Neurosurgery, and.
authors.forename: Yukinori
authors.initials: Y
authors.lastname: Akiyama
authors.affiliation: Neurosurgery, and.
authors.forename: Satoshi
authors.initials: S
authors.lastname: Iihoshi
authors.affiliation: Neurosurgery, and.
authors.forename: Masahiko
authors.initials: M
authors.lastname: Wanibuchi
authors.affiliation: Neurosurgery, and.
authors.forename: Nobuhiro
authors.initials: N
authors.lastname: Mikuni
authors.affiliation: Departments of 1 Emergency Medicine.
authors.forename: Shuji
authors.initials: S
authors.lastname: Uemura
authors.affiliation: Departments of 1 Emergency Medicine.
authors.forename: Katsutoshi
authors.initials: K
authors.lastname: Tanno
authors.affiliation: Departments of 1 Emergency Medicine.|Japan Neurotrauma Data Bank Committee, Japan Society of Neurotraumatology, Tokyo, Japan.
authors.forename: Eichi
authors.initials: E
authors.lastname: Narimatsu
authors.affiliation: Departments of 1 Emergency Medicine.|Japan Neurotrauma Data Bank Committee, Japan Society of Neurotraumatology, Tokyo, Japan.
authors.forename: Yasufumi
authors.initials: Y
authors.lastname: Asai
mesh_terms: D000293:Adolescent; D000328:Adult; D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D001831:Body Temperature; D001930:Brain Injuries / Q000401:mortality / Q000601:surgery / Q000628:therapy*; D015331:Cohort Studies; D016208:Databases, Factual; D023381:Endpoint Determination; D005260:Female; D015600:Glasgow Coma Scale; D017052:Hospital Mortality; D006801:Humans; D007036:Hypothermia, Induced; D007564:Japan / Q000453:epidemiology; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D019635:Neurosurgical Procedures; D057216:Propensity Score; D011446:Prospective Studies; D016019:Survival Analysis; D016896:Treatment Outcome; D055815:Young Adult
keywords: AED = antiepilepsy drug; AIS = Abbreviated Injury Scale; DI = diffuse injury; DNAR = do not attempt resuscitation; GCS = Glasgow Coma Scale; GOS = Glasgow Outcome Scale; ICP = intracranial pressure; ICU = intensive care unit; ISS = Injury Severity Score; IVH = intraventricular hemorrhage; JNTDB = Japan Neurotrauma Data Bank; NABIS = National Acute Brain Injury Study; NMBD = neuromuscular blockage drug; NTCDB = National Traumatic Coma Data Bank; PS = propensity score; T&D = talk and deteriorate; TBI = traumatic brain injury; TH = therapeutic hypothermia; TN = therapeutic normothermia; TTM = therapeutic temperature modulation; eML= evacuated mass lesion; hypothermia; neurocritical care; normothermia; propensity; tSAH = traumatic subarachnoid hemorrhage; therapeutic temperature modulation; traumatic brain injury