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• W2918247410 abstract "The use of hypothermia in severe traumatic brain injury (TBI) is controversial. Prior studies supporting the neuroprotective effects of prophylactic hypothermia are often criticized for methodological limitations including small sample sizes and brief periods of cooling. A 2007 meta-analysis1 of 6 randomized controlled trials studying targeted cooling for TBI did not show a significant decrease in mortality. However, a 2018 meta-analysis2 including contemporary trials has suggested decreased risk of mortality with prophylactic hypothermia targeting temperatures between 33°C and 35°C, prolonged cooling, and slow rewarming. Given these mixed findings, prophylactic hypothermia for severe TBI is recommended as level III evidence. To address the ambiguity surrounding hypothermic treatment of TBI and limitations of prior studies, Cooper et al3 recently published the results of the Prophylactic Hypothermia Trial to Lessen Traumatic Brain Injury (POLAR) in the Journal of the American Medical Association. POLAR was an international, multicenter, prospective, randomized trial that utilized standardized protocols for rapid and early cooling, prolonged hypothermia, and gradual rewarming while accounting for intracranial pressure (ICP).4 TBI patients between 18 and 60 yr of age with a Glasgow Coma Scale (GCS) less than 9 and requiring endotracheal intubation were eligible for enrollment in the study. Elevated ICP refractory to medical treatment was not an inclusion criterion. Patients were randomized into 2 groups: 266 patients were assigned prophylactic hypothermia and 245 were assigned controlled normothermia. Blinded independent assessors followed patients for 6 mo postrandomization via phone survey. Hypothermia was induced rapidly to a target temperature of 33°C to 35°C and maintained for 72 h if no signs of adverse effects were observed. Gradual post-treatment rewarming was performed with ICP monitoring and continued if ICP remained less than 20 mmHg. The primary outcome was favorable (5-8) or unfavorable (<5) GOS-Extended score at 6 mo follow-up. Secondary outcomes included adverse events within 10 d of randomization, 6 mo mortality, duration of mechanical ventilation, and length of hospitalization. The POLAR trial did not detect a significant difference in functional outcome at 6 mo between hypothermic and normothermic groups using an intent-to-treat analysis (RR = 0.99; 95% CI [0.82-1.19]; P = .94). Additionally, there was no significant difference in mortality, infections, or hemorrhagic events between groups. However, a significant rate of protocol deviation occurred post randomization. Ninety-nine (38%) patients originally assigned to the hypothermia arm were withdrawn due to adverse events, physician decision, or reassessment of TBI as less severe than judged on presentation. Twenty-three (9.6%) patients assigned to the normothermia arm experienced non-protocol mild hypothermia (33°C -35°C) for >1 h during treatment. In both perprotocol and astreated analyses, the only outcome that reached statistical significance was the risk of developing pneumonia, observed to be greater in the hypothermia group (perprotocol: RR = 1.23, 95% CI = [1.04-1.47], P = .02; as-treated: RR = 1.29, 95% CI = [1.09-1.53], P = .003). This study utilizes a set of narrowly defined treatment parameters – prophylactic and mild hypothermia, prolonged cooling, and targeted rewarming – that have shown promise to improve outcomes in severe TBI patients.2 Despite careful selection of study parameters, these data were unable to detect a difference in functional outcomes 6 mo after randomization between patients undergoing prophylactic hypothermia or controlled normothermia after TBI. Given the current data available, it may be time to reconsider the current recommendation for prophylactic hypothermia in severe TBI. Disclosures The authors have no personal, financial, or institutional interest in any of the drugs, materials, or devices described in this article." @default.
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• W2918247410 date "2019-03-04" @default.
• W2918247410 modified "2023-10-17" @default.
• W2918247410 title "Reconsidering Hypothermia for Severe Traumatic Brain Injury" @default.
• W2918247410 cites W2801869729 @default.
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• W2918247410 doi "https://doi.org/10.1093/neuros/nyz036" @default.
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