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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00155987




Registration number
NCT00155987
Ethics application status
Date submitted
7/09/2005
Date registered
12/09/2005
Date last updated
10/09/2020

Titles & IDs
Public title
The DECRA Trial: Early Decompressive Craniectomy in Patients With Severe Traumatic Brain Injury
Scientific title
Multi-centre Prospective Randomised Trial of Early Decompressive Craniectomy in Patients With Severe Traumatic Brain Injury
Secondary ID [1] 0 0
68/02
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Brain Injuries 0 0
Condition category
Condition code
Injuries and Accidents 0 0 0 0
Other injuries and accidents
Neurological 0 0 0 0
Other neurological disorders
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Early decompressive craniectomy

Treatment: Surgery: Early decompressive craniectomy
Large bifrontotemporal decompressive craniectomy
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion (%) of favourable outcomes (GOSE 5-8)
Timepoint [1] 0 0
6 month post injury
Secondary outcome [1] 0 0
Mean and maximum hourly intracranial pressure (ICP)
Timepoint [1] 0 0
36hrs post randomisation
Secondary outcome [2] 0 0
Favourable outcomes (GOSE)
Timepoint [2] 0 0
12 months post injury
Secondary outcome [3] 0 0
Mean GOSE using ordinal logistic regression
Timepoint [3] 0 0
6 months and 12 months
Secondary outcome [4] 0 0
Mortality
Timepoint [4] 0 0
hospital, 6 months, 12 months
Secondary outcome [5] 0 0
length of stay
Timepoint [5] 0 0
ICU admisssion
Secondary outcome [6] 0 0
Brain metabolites using microdialysis (The Alfred Hospital only)
Timepoint [6] 0 0
During monitoring phase

Eligibility
Key inclusion criteria
* Age 15 - 60 years and within the first 72 hrs from time of injury
* Severe diffuse Traumatic Brain Injury defined as:
* GCS < 9 and CT scan* with any evidence of brain swelling CT brain scan (DII + some evidence of swelling or DIII or DIV) OR
* GCS >8 before intubation and DIII or DIV CT brain scan (basal cistern compression ± midline shift)
* ICP monitor in situ. EVD recommended.
* "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 EVD venting) of >20mm Hg for more than 15 mins (continuously or cumulative over one hour).
Minimum age
15 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

* Intracranial haemorrhage > 3 cm diameter
* Intracranial mixed haemorrhagic contusion >5cm in long axis
* Previous craniectomy
* EDH/SDH/ or large contusion requiring evacuation
* EDH/SDH >0.5 cm thickness
* Spinal cord injury
* Penetrating brain injury
* Arrest at scene
* Unreactive pupils >4mm, and GCS=3
* Neurosurgery contraindicated (eg: severe coagulopathy)
* No chance of survival after consideration of CT and clinical findings following Neurosurgical consultant assessment (eg hemispheric infarct after carotid dissection).

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2010
Sample size
Target
Accrual to date
Final
155
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
National Trauma Research Institute
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
National Health and Medical Research Council, Australia
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Victorian Trauma Foundation
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
ANZICS Foundation
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Western Australian Institute for Medical Research
Address [4] 0 0
Country [4] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This is a multi-centre randomised trial to evaluate the effect of early decompressive craniectomy on neurological function in patients with severe traumatic brain injury.

The primary outcome is neurological function measured at 6 months post injury using the Glasgow Outcome Score. Neurological function is qualified as proportion of favourable outcomes (Glasgow Outcome Score Extended \[GOSE\] grades 5-8).
Trial website
https://clinicaltrials.gov/study/NCT00155987
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
D. J. Cooper
Address 0 0
The Alfred Hospital & National Trauma Research Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00155987