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

ISRCTN	ISRCTN61037228
DOI	https://doi.org/10.1186/ISRCTN61037228
Secondary identifying numbers	N/A

Submission date: 16/06/2005
Registration date: 21/07/2005
Last edited: 04/10/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Injury, Occupational Diseases, Poisoning

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Contact information

Prof Jamie Cooper
Scientific

Intensive Care
The Alfred
Commercial Road
Melbourne
3004
Australia

Phone	+61 (0)3 92071806
Email	J.Cooper@alfred.org.au

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use contact details to request a participant information sheet
Scientific title	Multi-centre prospective randomised trial of early decompressive craniectomy in patients with severe traumatic brain injury
Study acronym	DECRA
Study objectives	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(s)	The Alfred Human Research Ethics Committee, 27/06/2002, ref: 68/02
Health condition(s) or problem(s) studied	Severe traumatic brain injury
Intervention	Early decompressive craniectomy versus best current medical management
Intervention type	Procedure/Surgery
Primary outcome measure	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 study start date	01/08/2003
Completion date	30/06/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	165
Key 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).
Key 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
Date of first enrolment	01/08/2003
Date of final enrolment	30/06/2011

Locations

Countries of recruitment

Australia

Study participating centre

The Alfred Hospital

Melbourne
3004
Australia

Sponsor information

National Trauma Research Institute, The Alfred Hospital (Australia)
Research organisation

PO Box 315
Prahran
3181
Australia

Phone	+61 (0)3 92071805
Email	J.Cooper@alfred.org.au
Website	http://www.ntri.com.au
"ROR"	https://ror.org/01wddqe20

Funders

Funder type

Research council

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

No information available

Victorian Trauma Foundation (Australia)

No information available

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

No information available

National Health and Medical Research Council (ref: 314502)
Government organisation / National government

Alternative name(s): NHMRC
Location: Australia

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/09/2008		Yes	No
Results article	results	21/04/2011		Yes	No

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.