Status:
COMPLETED
The DECRA Trial: Early Decompressive Craniectomy in Patients With Severe Traumatic Brain Injury
Lead Sponsor:
National Trauma Research Institute
Collaborating Sponsors:
National Health and Medical Research Council, Australia
Victorian Trauma Foundation
Conditions:
Brain Injuries
Eligibility:
All Genders
15-60 years
Phase:
PHASE3
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 neuro...
Detailed Description
Comparison After meeting the entry criteria, and the patient will be randomised to either early DC surgery (see below) or best current conventional management. Those randomised to surgery will have th...
Eligibility Criteria
Inclusion
- 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).
- 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).
Exclusion
Key Trial Info
Start Date :
August 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
155 Patients enrolled
Trial Details
Trial ID
NCT00155987
Start Date
August 1 2003
End Date
December 1 2010
Last Update
September 10 2020
Active Locations (1)
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1
The Alfred Hospital
Melbourne, Victoria, Australia, 3004