Early decompressive craniectomy for patients with severe traumatic brain injury and refractory intracranial hypertension--a pilot randomized trial

J Crit Care. 2008 Sep;23(3):387-93. doi: 10.1016/j.jcrc.2007.05.002. Epub 2007 Dec 11.


Purpose: 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.

Materials and 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.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Brain Injuries / surgery*
  • Craniotomy / methods*
  • Female
  • Humans
  • Informed Consent
  • Intensive Care Units
  • Intracranial Hypertension / surgery*
  • Male
  • Middle Aged
  • Patient Selection
  • Pilot Projects
  • Time Factors
  • Young Adult