Ignite Creation Date:
2024-05-06 @ 9:30 AM
Last Modification Date:
2024-10-26 @ 12:15 PM
Study NCT ID:
NCT02995928
Status:
UNKNOWN
Last Update Posted:
2017-05-10
First Post:
2016-11-27
Brief Title:
Trial of Prophylactic Decompressive Craniectomy for Poor-grade Aneurysmal Subarachnoid Hemorrhage
Sponsor:
Tang-Du Hospital
Organization:
Tang-Du Hospital
Study Overview
Official Title:
Trial of Prophylactic Decompressive Craniectomy for Poor-grade Aneurysmal Subarachnoid Hemorrhage
Status:
UNKNOWN
Status Verified Date:
2017-03
Last Known Status:
RECRUITING
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:
Decompressive craniectomy has been reported for the treatment of patients with aneurysmal subarachnoid hemorrhage aSAH But no prospective randomised controlled trials have yet been undertaken to confirm its effectThe purpose of the study is to determine whether decompressive craniectomy combine aneurysm clipping surgery or endovascular coiling will improve clinical outcomes of poor-grade aSAH patients
Detailed Description:
Aneurysmal subarachnoid hemorrhage aSAH is a worldwide health burden with high fatality and permanent disability rates Decompressive craniectomy which is beneficial in patients with malignant middle cerebral artery infarction may indirectly relieve the mass effect decrease perihematomal tissue pressure improve blood flow reduce secondary brain damage and improve outcome without further damage to the brain due to surgery Early therapy with either surgical clipping or neuroradiologic intervention with endovascular coiling is the primary treatment for aSAH But whether decompressive craniectomy should be employed during the clipping surgery or immediately after coil embolization still have considerable controversy 80 patients will be recruited to the trial over 12 months Follow-up will take 6 months with analysis and reporting taking 6 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None