• Georgene W Hergenroeder, Shoji Yokobori, Huimahn Alex Choi, Karl Schmitt, Michelle A Detry, Lisa H Schmitt, Anna McGlothlin, Ava M Puccio, Jonathan Jagid, Yasuhiro Kuroda, Yukihiko Nakamura, Eiichi Suehiro, Faiz Ahmad, Kert Viele, Elisabeth A Wilde, Stephen R McCauley, Ryan S Kitagawa, Nancy R Temkin, Shelly D Timmons, Michael N Diringer, Pramod K Dash, Ross Bullock, David O Okonkwo, Donald A Berry, and Dong H Kim.
• The Vivian L. Smith Department of Neurosurgery, McGovern Medical School, University of Texas Health Science Center at Houston, 6431 Fannin Street, MSB 7.156, Houston, TX, 77030, USA. Georgene.W.Hergenroeder@uth.tmc.edu.
• Neurocrit Care. 2022 Apr 1; 36 (2): 560-572.

BackgroundHypothermia is neuroprotective in some ischemia-reperfusion injuries. Ischemia-reperfusion injury may occur with traumatic subdural hematoma (SDH). This study aimed to determine whether early induction and maintenance of hypothermia in patients with acute SDH would lead to decreased ischemia-reperfusion injury and improve global neurologic outcome.MethodsThis international, multicenter randomized controlled trial enrolled adult patients with SDH requiring evacuation of hematoma within 6 h of injury. The intervention was controlled temperature management of hypothermia to 35 °C prior to dura opening followed by 33 °C for 48 h compared with normothermia (37 °C). Investigators randomly assigned patients at a 1:1 ratio between hypothermia and normothermia. Blinded evaluators assessed outcome using a 6-month Glasgow Outcome Scale Extended score. Investigators measured circulating glial fibrillary acidic protein and ubiquitin C-terminal hydrolase L1 levels.ResultsIndependent statisticians performed an interim analysis of 31 patients to assess the predictive probability of success and the Data and Safety Monitoring Board recommended the early termination of the study because of futility. Thirty-two patients, 16 per arm, were analyzed. Favorable 6-month Glasgow Outcome Scale Extended outcomes were not statistically significantly different between hypothermia vs. normothermia groups (6 of 16, 38% vs. 4 of 16, 25%; odds ratio 1.8 [95% confidence interval 0.39 to ∞], p = .35). Plasma levels of glial fibrillary acidic protein (p = .036), but not ubiquitin C-terminal hydrolase L1 (p = .26), were lower in the patients with favorable outcome compared with those with unfavorable outcome, but differences were not identified by temperature group. Adverse events were similar between groups.ConclusionsThis trial of hypothermia after acute SDH evacuation was terminated because of a low predictive probability of meeting the study objectives. There was no statistically significant difference in functional outcome identified between temperature groups.© 2021. The Author(s).

20 keywords...

hide…