title: Fever Control Management Is Preferable to Mild Therapeutic Hypothermia in Traumatic Brain Injury Patients with Abbreviated Injury Scale 3-4: A Multi-Center, Randomized Controlled Trial.
abstract: In our prospective, multi-center, randomized controlled trial (RCT)-the Brain Hypothermia (B-HYPO) study-we could not show any difference on neurological outcomes in patients probably because of the heterogeneity in the severity of their traumatic condition. We therefore aimed to clarify and compare the effectiveness of the two therapeutic temperature management regimens in severe (Abbreviated Injury Scale [AIS] 3-4) or critical trauma patients (AIS 5). In the present post hoc B-HYPO study, we re-evaluated data based on the severity of trauma as AIS 3-4 or AIS 5 and compared Glasgow Outcome Scale score and mortality at 6 months by per-protocol analyses. Consequently, 135 patients were enrolled. Finally, 129 patients, that is, 47 and 31 patients with AIS 3-4 and 36 and 15 patients with AIS 5 were allocated to the mild therapeutic hypothermia (MTH) and fever control groups, respectively. No significant intergroup differences were observed with regard to age, gender, scores on head computed tomography (CT) scans, and surgical operation for traumatic brain injury (TBI), except for Injury Severity Score (ISS) in AIS 5. The fever control group demonstrated a significant reduction of TBI-related mortality compared with the MTH group (9.7% vs. 34.0%, p = 0.02) and an increase of favorable neurological outcomes (64.5% vs. 51.1%, p = 0.26) in patients with AIS 3-4, although the latter was not statistically significant. There was no difference in mortality or favorable outcome in patients with AIS 5. Fever control may be considered instead of MTH in patients with TBI (AIS 3-4).
authors.affiliation: 1 Department of Emergency, Disaster and Critical Care Medicine, Kagawa University Hospital , Kagawa, Japan .
authors.forename: Toru
authors.initials: T
authors.lastname: Hifumi
authors.affiliation: 1 Department of Emergency, Disaster and Critical Care Medicine, Kagawa University Hospital , Kagawa, Japan .
authors.forename: Yasuhiro
authors.initials: Y
authors.lastname: Kuroda
authors.affiliation: 1 Department of Emergency, Disaster and Critical Care Medicine, Kagawa University Hospital , Kagawa, Japan .
authors.forename: Kenya
authors.initials: K
authors.lastname: Kawakita
authors.affiliation: 2 Department of Emergency Medicine, Tokuyama Central Hospital , Yamaguchi, Japan .
authors.forename: Susumu
authors.initials: S
authors.lastname: Yamashita
authors.affiliation: 3 Advanced Medical Emergency and Critical Care Center, Yamaguchi University School of Medicine , Yamaguchi, Japan .
authors.forename: Yasutaka
authors.initials: Y
authors.lastname: Oda
authors.affiliation: 4 Department of Emergency Medicine, School of Medicine, Jikei University , Tokyo, Japan .
authors.forename: Kenji
authors.initials: K
authors.lastname: Dohi
authors.affiliation: 5 Yamaguchi Prefectural Grand Medical Center , Yamaguchi, Japan .
authors.forename: Tsuyoshi
authors.initials: T
authors.lastname: Maekawa
mesh_terms: D015998:Abbreviated Injury Scale; D000293:Adolescent; D000328:Adult; D000368:Aged; D001831:Body Temperature / Q000502:physiology*; D000070642:Brain Injuries, Traumatic / Q000175:diagnosis* / Q000401:mortality / Q000628:therapy*; D019468:Disease Management; D005260:Female; D023261:Glasgow Outcome Scale; D006801:Humans; D007036:Hypothermia, Induced / Q000379:methods*; D008297:Male; D008875:Middle Aged; D010043:Outcome and Process Assessment, Health Care; D011446:Prospective Studies; D055815:Young Adult
keywords: Abbreviated Injury Scale; heterogeneous pathophysiology; multi-center randomized controlled trial; therapeutic hypothermia; traumatic brain injury