Abstract
IntroductionResearch into therapeutic hypothermia following traumatic brain injury has been characterised by small trials of poor methodological quality, producing variable results. The Cochrane review, published in 2009, now requires updating. The aim of this systematic review is to assess the effectiveness of the application of therapeutic hypothermia to reduce death and disability when administered to adult patients who have been admitted to hospital following traumatic brain injury.MethodsTwo authors extracted data from each trial. Unless stated in the trial report, relative risks and 95% confidence intervals (CIs) were calculated for each trial. We considered P < 0 · 05 to be statistically significant. We combined data from all trials to estimate the pooled risk ratio (RR) with 95% confidence intervals for death, unfavourable outcome, and pneumonia. All statistical analyses were performed using RevMan 5.1 (Cochrane IMS, Oxford, UK) and Stata (Intercooled Version 12.0, StataCorp LP). Pooled RRs were calculated using the Mantel-Haenszel estimator. The random effects model of DerSimonian and Laird was used to estimate variances for the Mantel-Haenszel and inverse variance estimators.ResultsTwenty studies are included in the review, while 18 provided mortality data. When the results of 18 trials that evaluated mortality as one of the outcomes were statistically aggregated, therapeutic hypothermia was associated with a significant reduction in mortality and a significant reduction in poor outcome. There was a lack of statistical evidence for an association between use of therapeutic hypothermia and increased onset of new pneumonia.ConclusionsIn contrast to previous reviews, this systematic review found some evidence to suggest that therapeutic hypothermia may be of benefit in the treatment of traumatic brain injury. The majority of trials were of low quality, with unclear allocation concealment. Low quality trials may overestimate the effectiveness of hypothermia treatment versus standard care. There remains a need for more, high quality, randomised control trials of therapeutic hypothermia after traumatic brain injury.PROSPERO Systematic Review Registration Number 2012: CRD42012002449.
Highlights
Research into therapeutic hypothermia following traumatic brain injury has been characterised by small trials of poor methodological quality, producing variable results
When the results of the 18 randomised controlled trial (RCT) were statistically aggregated, therapeutic hypothermia was associated with a significant reduction in mortality (relative risk (RR) = 1.31, 95% confidence intervals (CIs) = 1.13 to 1.52, P = 0.0004)
When the results of the 14 RCTs were statistically aggregated, therapeutic hypothermia was associated with a significant reduction in mortality (RR = 1.62, 95% CI = 1.30, 2.01, P
Summary
Research into therapeutic hypothermia following traumatic brain injury has been characterised by small trials of poor methodological quality, producing variable results. The aim of this systematic review is to assess the effectiveness of the application of therapeutic hypothermia to reduce death and disability when administered to adult patients who have been admitted to hospital following traumatic brain injury. Research in the 1980s using animal models demonstrated the benefits of cooling to 32 to 34°C [1,2], and it has since been proposed that there are a number of potential applications for therapeutic hypothermia [3]. NICE guidelines for the use of therapeutic hypothermia in cardiac arrest have been published [5]. In the United States, the American Heart Association recommends hypothermia as a standard of care for survivors of cardiac arrest as there is sufficient evidence to support improvements in outcome with its use [6]. Whilst a number of studies have identified an improvement in outcome with the application of therapeutic hypothermia following stroke [7], the question as to whether therapeutic hypothermia is of benefit in traumatic brain injury (TBI) remains unanswered
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