Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2025-12-26 @ 12:44 AM
Study NCT ID:
NCT05206760
Status:
COMPLETED
Last Update Posted:
2022-01-25
First Post:
2021-05-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Severe Head Injury Brain Analysis
Sponsor:
Queen Mary University of London
Organization:
Study Overview
Official Title:
Severe Head Injury Brain Analysis
Status:
COMPLETED
Status Verified Date:
2021-05
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:
SHIBA
Brief Summary:
Safety and feasibility study investigating brain biopsy in severe head injury. When a patient undergoes craniotomy or ICP bolt insertion for trauma, a biopsy of brain tissue is taken.
Blood, saliva, urine and faeces samples are also taken for 7 days following the brain biopsy.
CSF is collected if a CSF drainage device is used.
Blood, saliva, urine and faeces samples are also taken for 7 days following the brain biopsy.
CSF is collected if a CSF drainage device is used.
Detailed Description:
A minor amendment was submitted to allow histological and immunohistochemical analysis of the samples.
Study Oversight
Has Oversight DMC:
True
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?: