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

Cooper, D. James; Rosenfeld, Jeffrey V.; Murray, Lynnette; Wolfe, Rory; Ponsford, Jennie; Davies, Andrew; D'Urso, Paul; Pellegrino, Vincent; Malham, Gregory; Kossmann, Thomas

doi:10.1016/j.jcrc.2007.05.002

« Previous Next »Journal of Critical Care
Volume 23, Issue 3 , Pages 387-393, September 2008

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

D. James Cooper, MD
- Department of Intensive Care, Alfred Hospital, Monash University, Melbourne 3004, Australia
- Department of Surgery, Monash University, Melbourne 3004, Australia
- Department of Epidemiology and Preventive Medicine, Monash University, Melbourne 3004, Australia
- National Trauma Research Institute, Melbourne 3004, Australia
- Corresponding author. National Trauma Research Institute, Melbourne 3004, Australia. Tel.: +61 3 9207 1805; fax: +61 3 9276 2343.
Jeffrey V. Rosenfeld, MS
- Department of Neurosurgery, Alfred Hospital, Monash University, Melbourne 3004, Australia
- Department of Surgery, Monash University, Melbourne 3004, Australia
- National Trauma Research Institute, Melbourne 3004, Australia
Lynnette Murray, BAppSci
- Department of Intensive Care, Alfred Hospital, Monash University, Melbourne 3004, Australia
- National Trauma Research Institute, Melbourne 3004, Australia
Rory Wolfe, PhD
- Department of Epidemiology and Preventive Medicine, Monash University, Melbourne 3004, Australia
Jennie Ponsford, PhD
- Department of Psychology, Monash University, Melbourne 3004, Australia
Andrew Davies, MBBS
- Department of Intensive Care, Alfred Hospital, Monash University, Melbourne 3004, Australia
Paul D'Urso, PhD
- National Trauma Research Institute, Melbourne 3004, Australia
Vincent Pellegrino, MBBS
- Department of Intensive Care, Alfred Hospital, Monash University, Melbourne 3004, Australia
Gregory Malham, MBBS
- Department of Neurosurgery, Alfred Hospital, Monash University, Melbourne 3004, Australia
- Department of Surgery, Monash University, Melbourne 3004, Australia
- National Trauma Research Institute, Melbourne 3004, Australia
Thomas Kossmann, MD
- Department of Trauma Surgery, Alfred Hospital, Monash University, Melbourne 3004, Australia
- National Trauma Research Institute, Melbourne 3004, Australia

published online 06 December 2007.

Abstract

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.

Keywords: Decompressive craniectomy, Diffuse traumatic brain injury, Intracranial hypertension