Condition category
Injury, Occupational Diseases, Poisoning
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Traumatic brain injury is a potentially devastating injury that mainly affects young males. About 10% of patients admitted with severe traumatic brain injury have a diffuse injury (over a widespread area) and persistent brain swelling that is difficult to control with medical treatment. Over the past decade, treatment of these patients has been shifting from barbiturate coma (a temporary coma) to decompressive craniectomy. This is a well-established surgical procedure in which a large piece of skull bone is removed, stored for 1-2 months and then replaced. The aim of this study is to assess the effectiveness of this procedure in patients with severe traumatic brain injury.

Who can participate?
Patients aged 15-60 with severe diffuse traumatic brain injury

What does the study involve?
Participants are randomly allocated to be treated with either the best medical care or decompressive craniectomy and best medical care. They are followed up to assess the outcome 6 months later.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
A number of hospitals in Australia, New Zealand, Saudi Arabia, Canada and the USA participated in the study with the lead site being the Alfred Hospital in Melbourne, Australia

When is the study starting and how long is it expected to run for?
August 2003 to June 2011

Who is funding the study?
National Health & Medical Research Council, the Victorian Trauma Foundation, Victorian Neurotrauma Initiative, Transport Accident Commission, Intensive Care Foundation, and the Western Australian Institute of Medical Research

Who is the main contact?
Prof. Jamie Cooper

Trial website

Contact information



Primary contact

Prof Jamie Cooper


Contact details

Intensive Care
The Alfred
Commercial Road
+61 (0)3 92071806

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

Multi-centre prospective randomised trial of early decompressive craniectomy in patients with severe traumatic brain injury



Study hypothesis

Study hypothesis:
That early decompressive craniectomy will improve long term neurological outcome in patients with severe traumatic brain injury and intracranial hypertension which is refractory to conventional management.

Ethics approval

The Alfred Human Research Ethics Committee, 27/06/2002, ref: 68/02

Study design

Randomised controlled trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use contact details to request a participant information sheet


Severe traumatic brain injury


Early decompressive craniectomy versus best current medical management

Intervention type



Drug names

Primary outcome measures

Glasgow Outcome Score (GOSE) measured 6 months after the injury. Proportion (%) of Favourable Outcomes (GOSE 5-8) is the primary outcome measure.

Secondary outcome measures

1. Mean and maximum hourly ICP
2. Favourable outcomes (GOSE 5-8) at 12 months post injury
3. Mean GOSE at 6 and 12 months using ordinal logistic regression
4. Mortality - hospital, 6 months, 12 months
5. Days in intensive care unit (ICU) and hospital

Overall trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

1. Age 15-60 years
2. First 72 hours from time of injury
3. Severe diffuse Traumatic Brain Injury defined as:
3.1. Glasgow Coma Score (GCS) <9 and computed tomography (CT) scan with any evidence of brain swelling. CT brain scan DII + some evidence of swelling or DIII or DIV
3.2. GCS >8 before intubation and DIII or DIV. CT brain scan basal cistern compression ± midline shift
4. Intracanial pressure (ICP) monitor in situ
5. 'Refractory ICP' despite best conventional management. Refractory ICP in this study will be defined as the spontaneous persistent increase in ICP despite optimal conventional ICU therapies (including intermittent external ventricular drain [EVD] venting) of >20 mm Hg for more than 15 mins (continuously or cumulative over one hour).

Participant type


Age group




Target number of participants


Participant exclusion criteria

1. Intracranial mass lesion (>3 cm diameter) and/or previous craniectomy
2. Extradural hematoma / subdural hematoma (EDH/SDH) requiring evacuation
3. EDH/SDH >0.5 cm thickness
4. Spinal cord injury
5. Penetrating brain injury
6. Arrest at scene
7. Unreactive pupils >4 mm and GCS = 3
8. Neurosurgery contraindicated
9. No chance of survival after consideration of CT and clinical findings, following Neurosurgical consultant assessment

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

The Alfred Hospital

Sponsor information


National Trauma Research Institute, The Alfred Hospital (Australia)

Sponsor details

PO Box 315
+61 (0)3 92071805

Sponsor type

Research organisation



Funder type

Research council

Funder name

Australian and New Zealand Intensive Care (ANZIC) Foundation (Australia/New Zealand)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Funder name

Victorian Trauma Foundation (Australia)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Funder name

Western Australian Institute for Medical Research (WAIMR), Neurotrauma Research Programme (Australia)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Funder name

National Health and Medical Research Council (ref: 314502)

Alternative name(s)


Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government



Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2008 results in:
2011 results in:

Publication citations

  1. Results

    Cooper DJ, Rosenfeld JV, Murray L, Wolfe R, Ponsford J, Davies A, D'Urso P, Pellegrino V, Malham G, Kossmann T, Early decompressive craniectomy for patients with severe traumatic brain injury and refractory intracranial hypertension--a pilot randomized trial., J Crit Care, 2008, 23, 3, 387-393, doi: 10.1016/j.jcrc.2007.05.002.

  2. Results

    Cooper DJ, Rosenfeld JV, Murray L, Arabi YM, Davies AR, D'Urso P, Kossmann T, Ponsford J, Seppelt I, Reilly P, Wolfe R, , , Decompressive craniectomy in diffuse traumatic brain injury., N. Engl. J. Med., 2011, 364, 16, 1493-1502, doi: 10.1056/NEJMoa1102077.

Additional files

Editorial Notes

04/10/2016: Plain English summary added. 19/08/2008: the following changes were made to the trial record: 1. The target number of participants has been changed from 210 to 165. 2. The overall trial end date has been changed from 30/06/2008 to 30/06/2011.