The DECRA Trial: Early Decompressive Craniectomy in Patients With Severe Traumatic Brain Injury
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|ClinicalTrials.gov Identifier: NCT00155987|
Recruitment Status : Unknown
Verified September 2009 by National Trauma Research Institute.
Recruitment status was: Active, not recruiting
First Posted : September 12, 2005
Last Update Posted : July 23, 2010
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).
|Condition or disease||Intervention/treatment||Phase|
|Brain Injuries||Procedure: Early decompressive craniectomy||Phase 3|
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 the operation done within 6 hours of randomisation. They will then return to the ICU and be managed thereafter in the same way as the conventional arm. Patients in the conventional arm will have all the usual therapies for increasing ICP optimised again. They then may have cooling to 35.0C or thiopentone bolus or thiopentone coma. These options are at the clinicians discretion. Late DC surgery in the control patients is discouraged however it may be done at the neurosurgeons discretion. These patients will be included in the intention to treat analysis.
Surgical Technique The technique described by Polin will be used. The operation will comprise bi-frontal decompressive craniectomies with a single fronto-temporal bone flap extending across the midline. The temporalis muscles will be reflected inferiorly. Burr holes are located either side of the sagittal sinus at the posterior extent and bilaterally at the keyhole and at the root of the zygoma. This will create a large bifrontal craniectomy defect extending posteriorly to the coronal sutures. Bilateral large sub-temporal decompressions will be performed down to the skull base. The final bone cut is made along the supra-orbital ridges with an attempt to preserve the frontal sinus. Burr holes will be placed either side of the sagittal sinus inferiorly and the bone will be lifted out.
The dura will be opened in one of two alternative ways:
- The dura is opened with a cruciate incision bilaterally. OR
- A large L shaped incision with the lower corner of the L facing laterally. The advantage to this method is that the cerebral veins are not disturbed medially by this incision.
The dural opening should be covered with a dural or facial patch, so that the brain does not adhere to the scalp. Water tight dural closure is not necessarily aimed for. For patients receiving EVD monitoring, an ICP monitor with ventricular catheter (± optional PO2 and temperature monitor) may be placed prior to closure. Some patients will have been randomised to parenchymal catheter only. These patients will not have an EVD inserted.
The bone flap is replaced once bone swelling has resolved and the patient has improved and left the intensive care unit (6-12 weeks). The bone flap is stored at minus 20o-70oC until reinsertion or it may be implanted in the subcutaneous tissue of the abdominal wall as an alternative.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||165 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Multi-centre Prospective Randomised Trial of Early Decompressive Craniectomy in Patients With Severe Traumatic Brain Injury|
|Study Start Date :||August 2003|
|Estimated Primary Completion Date :||November 2010|
|Estimated Study Completion Date :||December 2010|
Procedure: Early decompressive craniectomy
- Proportion (%) of favourable outcomes (GOSE 5-8) [ Time Frame: 6 month post injury ]
- Mean and maximum hourly intracranial pressure (ICP) [ Time Frame: 36hrs post randomisation ]
- Favourable outcomes (GOSE) [ Time Frame: 12 months post injury ]
- Mean GOSE using ordinal logistic regression [ Time Frame: 6 months and 12 months ]
- Mortality [ Time Frame: hospital, 6 months, 12 months ]
- length of stay [ Time Frame: ICU admisssion ]
- Brain metabolites using microdialysis (The Alfred Hospital only) [ Time Frame: During monitoring phase ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00155987
|The Alfred Hospital|
|Melbourne, Victoria, Australia, 3004|
|Principal Investigator:||D. J. Cooper||The Alfred Hospital & National Trauma Research Institute|