title: 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.
abstract: 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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  Current Controlled Trials: ISRCTN34555414.
authors.affiliation: Department of Anaesthesia and Pain Management, University of Edinburgh, Edinburgh, UK. p.andrews@ed.ac.uk.
authors.forename: Peter J D
authors.initials: PJ
authors.lastname: Andrews
authors.forename: Louise H
authors.initials: LH
authors.lastname: Sinclair
authors.forename: Bridget
authors.initials: B
authors.lastname: Harris
authors.forename: Melissa J
authors.initials: MJ
authors.lastname: Baldwin
authors.forename: Claire G
authors.initials: CG
authors.lastname: Battison
authors.forename: Jonathan K J
authors.initials: JK
authors.lastname: Rhodes
authors.forename: Gordon
authors.initials: G
authors.lastname: Murray
authors.forename: Daniel
authors.initials: D
authors.lastname: De Backer
mesh_terms: D001930:Brain Injuries / Q000175:diagnosis / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D005060:Europe; D005240:Feasibility Studies; D006801:Humans; D007036:Hypothermia, Induced / Q000009:adverse effects / Q000401:mortality; D007194:India; D019586:Intracranial Hypertension / Q000175:diagnosis / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D007427:Intracranial Pressure; D010865:Pilot Projects; D018401:Sample Size; D013997:Time Factors; D016896:Treatment Outcome