Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000009617
Ethics application status
Approved
Date submitted
12/07/2005
Date registered
14/07/2005
Date last updated
11/03/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
The DECRA trial
Scientific title
Multi-centre randomised trial to evaluate the effect of early decompressive craniectomy on neurological function in patients with severe traumatic brain injury
Secondary ID [1] 287819 0
Nil known
Universal Trial Number (UTN)
Trial acronym
DECRA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Severe diffuse traumatic brain injury with refractory intracranial hypertension 71 0
Condition category
Condition code
Neurological 83 83 0 0
Other neurological disorders
Neurological 84 84 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Early decompressive craniectomy
Intervention code [1] 14 0
Treatment: Surgery
Comparator / control treatment
Best current medical management
Control group
Active

Outcomes
Primary outcome [1] 115 0
Neurological function using the Glasgow Outcome Score. Neurological function is quantified as proportion of favourable outcomes (GOSE grades 5-8)
Timepoint [1] 115 0
Measured at 6 months post injury
Secondary outcome [1] 264 0
Mean and maximum hourly ICP.
Timepoint [1] 264 0
72HRS POST RANDOMISATION
Secondary outcome [2] 265 0
Favourable outcomes (GOSE 5-8).
Timepoint [2] 265 0
At 12 months post injury.
Secondary outcome [3] 266 0
Mean GOSE
Timepoint [3] 266 0
At 6 and 12 months using ordinal logistic regression.
Secondary outcome [4] 267 0
Mortality
Timepoint [4] 267 0
hospital 6 months, 12 months
Secondary outcome [5] 268 0
Days in ICU and hospital
Timepoint [5] 268 0
ICU discharge, Hospital discharge
Secondary outcome [6] 269 0
Brain metabolites using microdialysis (The Alfred only).
Timepoint [6] 269 0
ICU admission
Secondary outcome [7] 321705 0
Multi-modality MRI scanning to assess and characterise long term brain injury characteristics .
Timepoint [7] 321705 0
5-10 years post randomisation, based on time of follow-up in April 2016.
Secondary outcome [8] 321706 0
Long-term level of recovery, assessed by the Glasgow coma score
Timepoint [8] 321706 0
5-10 years post randomisation, based on time of follow-up in April 2016.

Eligibility
Key inclusion criteria
First 72 hours from time of injury-Severe diffuse traumatic brain injury-ICP monitor in-situ -Refractory intracranial hypertension
Minimum age
15 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Mass lesion>3cm-EDH/SDH>0.5cm or requiring evacuation-Spinal cord injury-Penetrating brain injury-Cardiac arrest at scene-Fixed dilated pupils and GCS=3-Neurosurgery contraindicated-No chance of survival after review of CT brain scan and clinical findings (Neurosurgeon decision).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Automated telephone allocation/randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The random allocation sequence will be generated by a computer program (StataCorp. Stata Statistical Software release 8.0) Randomisation will be in variable block sizes. Randomisation will be stratified first by centre and secondly by EVD presence
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/08/2003
Actual
25/08/2003
Date of last participant enrolment
Anticipated
Actual
16/04/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
165
Accrual to date
Final
155
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,WA

Funding & Sponsors
Funding source category [1] 119 0
Government body
Name [1] 119 0
National Health & Medical Research Council
Country [1] 119 0
Australia
Funding source category [2] 120 0
Charities/Societies/Foundations
Name [2] 120 0
Victorian Trauma Foundation
Country [2] 120 0
Australia
Funding source category [3] 121 0
Charities/Societies/Foundations
Name [3] 121 0
ANZ Intensive Care Foundation
Country [3] 121 0
Australia
Funding source category [4] 122 0
Charities/Societies/Foundations
Name [4] 122 0
WA Institute for Medical Research
Country [4] 122 0
Australia
Funding source category [5] 3752 0
Charities/Societies/Foundations
Name [5] 3752 0
Victorian Neurotrauma Initiative
Country [5] 3752 0
Australia
Primary sponsor type
Other
Name
National Trauma Research Institute, The Alfred
Address
89 Commercial Rd
Melbourne, Vic, 3004
Country
Australia
Secondary sponsor category [1] 88 0
None
Name [1] 88 0
Nil
Address [1] 88 0
Country [1] 88 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 856 0
The Alfred Hospital
Ethics committee address [1] 856 0
Commercial Rd
Melbourne, Vic, 3004
Ethics committee country [1] 856 0
Australia
Date submitted for ethics approval [1] 856 0
Approval date [1] 856 0
29/05/2002
Ethics approval number [1] 856 0
Ethics committee name [2] 857 0
Royal Melbourne Hospital
Ethics committee address [2] 857 0
Ethics committee country [2] 857 0
Australia
Date submitted for ethics approval [2] 857 0
Approval date [2] 857 0
Ethics approval number [2] 857 0
Ethics committee name [3] 858 0
Royal Adelaide Hospital
Ethics committee address [3] 858 0
Ethics committee country [3] 858 0
Australia
Date submitted for ethics approval [3] 858 0
Approval date [3] 858 0
Ethics approval number [3] 858 0
Ethics committee name [4] 859 0
Royal Perth Hospital
Ethics committee address [4] 859 0
Ethics committee country [4] 859 0
Australia
Date submitted for ethics approval [4] 859 0
Approval date [4] 859 0
Ethics approval number [4] 859 0
Ethics committee name [5] 860 0
Sir Charles Gairdner Hospial
Ethics committee address [5] 860 0
Ethics committee country [5] 860 0
Australia
Date submitted for ethics approval [5] 860 0
Approval date [5] 860 0
Ethics approval number [5] 860 0
Ethics committee name [6] 861 0
Royal North Shore Hospital
Ethics committee address [6] 861 0
Ethics committee country [6] 861 0
Australia
Date submitted for ethics approval [6] 861 0
Approval date [6] 861 0
Ethics approval number [6] 861 0
Ethics committee name [7] 862 0
John Hunter Hospital
Ethics committee address [7] 862 0
Ethics committee country [7] 862 0
Australia
Date submitted for ethics approval [7] 862 0
Approval date [7] 862 0
Ethics approval number [7] 862 0
Ethics committee name [8] 863 0
Nepean Hospital
Ethics committee address [8] 863 0
Ethics committee country [8] 863 0
Australia
Date submitted for ethics approval [8] 863 0
Approval date [8] 863 0
Ethics approval number [8] 863 0
Ethics committee name [9] 864 0
Liverpool Hospital
Ethics committee address [9] 864 0
Ethics committee country [9] 864 0
Australia
Date submitted for ethics approval [9] 864 0
Approval date [9] 864 0
Ethics approval number [9] 864 0
Ethics committee name [10] 865 0
Westmead Hospital
Ethics committee address [10] 865 0
Ethics committee country [10] 865 0
Australia
Date submitted for ethics approval [10] 865 0
Approval date [10] 865 0
Ethics approval number [10] 865 0
Ethics committee name [11] 866 0
Gold Coast Hospital
Ethics committee address [11] 866 0
Ethics committee country [11] 866 0
Australia
Date submitted for ethics approval [11] 866 0
Approval date [11] 866 0
Ethics approval number [11] 866 0
Ethics committee name [12] 867 0
Princess Alexandra Hospital
Ethics committee address [12] 867 0
Ethics committee country [12] 867 0
Australia
Date submitted for ethics approval [12] 867 0
Approval date [12] 867 0
Ethics approval number [12] 867 0
Ethics committee name [13] 868 0
Auckland Hospital
Ethics committee address [13] 868 0
Ethics committee country [13] 868 0
New Zealand
Date submitted for ethics approval [13] 868 0
Approval date [13] 868 0
Ethics approval number [13] 868 0
Ethics committee name [14] 869 0
Christchurch Hospital
Ethics committee address [14] 869 0
Ethics committee country [14] 869 0
New Zealand
Date submitted for ethics approval [14] 869 0
Approval date [14] 869 0
Ethics approval number [14] 869 0
Ethics committee name [15] 870 0
Wellington Hospital
Ethics committee address [15] 870 0
Ethics committee country [15] 870 0
New Zealand
Date submitted for ethics approval [15] 870 0
Approval date [15] 870 0
Ethics approval number [15] 870 0
Ethics committee name [16] 871 0
Hamilton Health Sciences
Ethics committee address [16] 871 0
Ethics committee country [16] 871 0
Canada
Date submitted for ethics approval [16] 871 0
Approval date [16] 871 0
Ethics approval number [16] 871 0

Summary
Brief summary
In adults with severe diffuse traumatic brain injury and refractory intracranial hypertension,
early bifrontotemporoparietal decompressive craniectomy decreased
intracranial pressure and the length of stay in the ICU but was associated with more
unfavorable outcomes.
Trial website
Trial related presentations / publications
Cooper DJ, Rosenfeld JV, Murray. LJ Decompressive crianectomy in diffuse traumatic brain injury. n engl j med 2011; 364;16:1493
Public notes

Contacts
Principal investigator
Name 35848 0
Prof D Jamie Cooper
Address 35848 0
The Alfred
Intensive Care Dept
Commercial Rd
Melbourne, 3004
Country 35848 0
Australia
Phone 35848 0
+61 3 99030343
Fax 35848 0
Email 35848 0
jamie.cooper@monash.edu
Contact person for public queries
Name 9203 0
Mrs Ms Lynne Murray
Address 9203 0
Intensive Care Research
The Alfred
Commercial Road
Melbourne VIC 3004
Country 9203 0
Australia
Phone 9203 0
+61 3 99030347
Fax 9203 0
+61 3 90763822
Email 9203 0
Lynnette.murray@monash.edu
Contact person for scientific queries
Name 131 0
Prof Jamie Cooper
Address 131 0
Intensive Care Research
The Alfred
Commercial Road
Melbourne VIC 3004
Country 131 0
Australia
Phone 131 0
+61 3 99030343
Fax 131 0
+61 3 92762343
Email 131 0
Jamie.cooper@monash.edu

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary