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
J.Cooper@alfred.org.au
Trial website
Contact information
Type
Scientific
Primary contact
Prof Jamie Cooper
ORCID ID
Contact details
Intensive Care
The Alfred
Commercial Road
Melbourne
3004
Australia
+61 (0)3 92071806
J.Cooper@alfred.org.au
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Multi-centre prospective randomised trial of early decompressive craniectomy in patients with severe traumatic brain injury
Acronym
DECRA
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
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Severe traumatic brain injury
Intervention
Early decompressive craniectomy versus best current medical management
Intervention type
Procedure/Surgery
Phase
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
01/08/2003
Overall trial end date
30/06/2011
Reason abandoned
Eligibility
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
OR
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
Patient
Age group
Adult
Gender
Both
Target number of participants
165
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
01/08/2003
Recruitment end date
30/06/2011
Locations
Countries of recruitment
Australia
Trial participating centre
The Alfred Hospital
Melbourne
3004
Australia
Sponsor information
Organisation
National Trauma Research Institute, The Alfred Hospital (Australia)
Sponsor details
PO Box 315
Prahran
3181
Australia
+61 (0)3 92071805
J.Cooper@alfred.org.au
Sponsor type
Research organisation
Website
Funders
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
Location
Funder name
Victorian Trauma Foundation (Australia)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Western Australian Institute for Medical Research (WAIMR), Neurotrauma Research Programme (Australia)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
National Health and Medical Research Council (ref: 314502)
Alternative name(s)
NHMRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
Australia
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: http://www.ncbi.nlm.nih.gov/pubmed/18725045
2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/21434843
Publication citations
-
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.
-
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.