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

Trials

Daniel De Backer⁴  Gordon Murray³  Jonathan K J Rhodes²  Claire G Battison²  Melissa J Baldwin¹  Bridget Harris²  Louise H Sinclair²  Peter J D Andrews² 

[1] NHS Lothian, Waverley Gate, 2-4 Waterloo Place, Edinburgh EH1 3EG, UK;Department of Anaesthesia and Pain Management, University of Edinburgh, Edinburgh, UK;Centre for Population Health Sciences, The University of Edinburgh, Medical School, Teviot Place, Edinburgh EH8 9AG, UK;Erasme University Hospital, Free University of Brussels, 808 Route de Lennick, Brussels B-1070, Belgium

关键词: Feasibility;    Randomized controlled trial;    Therapeutic hypothermia;    Traumatic brain injury;   

Others  :  1093132
DOI  :  10.1186/1745-6215-14-277

 received in 2013-04-12, accepted in 2013-08-22,  发布年份 2013

【 摘 要 】

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.

【 授权许可】

   
2013 Andrews et al.; licensee BioMed Central Ltd.

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