Ignite Creation Date:
2024-05-05 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00155987
Status:
COMPLETED
Last Update Posted:
2020-09-10
First Post:
2005-09-07
Brief Title:
The DECRA Trial Early Decompressive Craniectomy in Patients With Severe Traumatic Brain Injury
Sponsor:
National Trauma Research Institute
Organization:
National Trauma Research Institute
Study Overview
Official Title:
Multi-centre Prospective Randomised Trial of Early Decompressive Craniectomy in Patients With Severe Traumatic Brain Injury
Status:
COMPLETED
Status Verified Date:
2020-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 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 350C 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
1 The dura is opened with a cruciate incision bilaterally OR
2 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
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
1 The dura is opened with a cruciate incision bilaterally OR
2 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None