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
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
Trial website
Trial related presentations / publications
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
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
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


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.