Therapeutic hypothermia

Study of therapeutic hypothermia (32 to 35°C) for intracranial pressure reduction after traumatic brain injury (the Eurotherm3235Trial): outcome of the pilot phase of the trial

Authors: Andrews PJ, Sinclair LH, Harris B, Baldwin MJ, Battison CG, Rhodes JK, Murray G, De Backer D.

BACKGROUND: Clinical trials in traumatic brain injury (TBI) are challenging. Previous trials of complex interventions were conducted in high-income countries, reported long lead times for site setup and low screened-to-recruitment rates.In this report we evaluate the internal pilot phase of an international, multicentre TBI trial of a complex intervention to assess: design and implementation of an online case report form; feasibility of recruitment (sites and patients); feasibility and effectiveness of delivery of the protocol.
METHODS: All aspects of the pilot phase of the trial were conducted as for the main trial. The pilot phase had oversight by independent Steering and Data Monitoring committees.
RESULTS: Forty sites across 12 countries gained ethical approval. Thirty seven of 40 sites were initiated for recruitment. Of these, 29 had screened patients and 21 randomized at least one patient. Lead times to ethics approval (6.8 weeks), hospital approval (18 weeks), interest to set up (61 weeks), set up to screening (11 weeks), and set up to randomization (31.6 weeks) are comparable with other international trials. Sixteen per cent of screened patients were eligible. We found 88% compliance rate with trial protocol.
CONCLUSION: The pilot data demonstrated good feasibility for this large international multicentre randomized controlled trial of hypothermia to control intracranial pressure. The sample size was reduced to 600 patients because of homogeneity of the patient group and we showed an optimized cooling intervention could be delivered.Trial registration Current Controlled Trials: ISRCTN34555414.

Therapeutic hypothermia for the management of intracranial hypertension in severe traumatic brain injury: A systematic review

Authors: Sadaka F, Veremakis C.

Background: Traumatic brain injury (TBI) is a major source of death and severe disability worldwide. Raised Intracranial pressure (ICP) is an important predictor of mortality in patients with severe TBI and aggressive treatment of elevated ICP has been shown to reduce mortality and improve outcome. The acute post-injury period in TBI is characterized by several pathophysiologic processes that start in the minutes to hours following injury. All of these processes are temperature-dependent; they are all aggravated by fever and inhibited by hypothermia. Methods: This study reviewed the current clinical evidence in support of the use of therapeutic hypothermia (TH) for the treatment of intracranial hypertension (ICH) in patients with severe TBI. Results: This study identified a total of 18 studies involving hypothermia for control of ICP; 13 were randomized controlled trials (RCT) and five were observational studies. TH (32-34°C) was effective in controlling ICH in all studies. In the 13 RCT, ICP in the TH group was always significantly lower than ICP in the normothermia group. In the five observational studies, ICP during TH was always significantly lower than prior to inducing TH. Conclusions: Pending results from large multi-centre studies evaluating the effect of TH on ICH and outcome, TH should be included as a therapeutic option to control ICP in patients with severe TBI.

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