title: Early decompressive craniectomy for patients with severe traumatic brain injury and refractory intracranial hypertension--a pilot randomized trial.
abstract: OBJECTIVE
  The aims of this study were to test the feasibility and to assess potential recruitment rates in a pilot study preliminary to a phase III randomized trial of decompressive craniectomy surgery in patients with diffuse traumatic brain injury (TBI) and refractory intracranial hypertension.
  
  
  METHODS
  A study protocol was developed, inclusion and exclusion criteria were defined, and a standardized surgical technique was established. Neurologic outcomes were assessed 6 months after injury with a validated structured questionnaire and a single trained assessor blind to treatment group.
  
  
  RESULTS
  During the 8-month pilot study at a level 1 trauma center in Melbourne, Australia, 69 intensive care patients with severe TBI were assessed for inclusion. Six patients were eligible, and 5 (8%) were randomized. Six months after injury, 100% of patients received outcome assessments. Key improvements to the multicenter Decompressive Craniectomy study protocol were enabled by the pilot study.
  
  
  CONCLUSIONS
  In patients with severe TBI and refractory intracranial hypertension, the frequency of favorable neurologic outcomes (independent living) was low and similar to predicted values (40% favorable). A future multicenter phase III trial involving 18 neurotrauma centers with most sites conservatively recruiting at just 25% of the pilot study rate would require at least 5 years to achieve an estimated 210-patient sample size. Collaboration with neurotrauma centers in countries other than Australia and New Zealand would be required for such a phase III trial to be successful.
authors: Department of Intensive Care, Alfred Hospital, Monash University, Melbourne 3004, Australia.
authors: D James
authors: DJ
authors: Cooper
authors: Jeffrey V
authors: JV
authors: Rosenfeld
authors: Lynnette
authors: L
authors: Murray
authors: Rory
authors: R
authors: Wolfe
authors: Jennie
authors: J
authors: Ponsford
authors: Andrew
authors: A
authors: Davies
authors: Paul
authors: P
authors: D'Urso
authors: Vincent
authors: V
authors: Pellegrino
authors: Gregory
authors: G
authors: Malham
authors: Thomas
authors: T
authors: Kossmann
mesh_terms: D000328:Adult; D001930:Brain Injuries / Q000601:surgery*; D003399:Craniotomy / Q000379:methods*; D005260:Female; D006801:Humans; D007258:Informed Consent; D007362:Intensive Care Units; D019586:Intracranial Hypertension / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D018579:Patient Selection; D010865:Pilot Projects; D013997:Time Factors; D055815:Young Adult