Ignite Creation Date:
2025-12-24 @ 7:57 PM
Ignite Modification Date:
2025-12-31 @ 5:45 AM
Study NCT ID:
NCT06498804
Status:
RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-04-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Blood Patch in the Management of Intracranial Hypotension
Sponsor:
University Hospital, Strasbourg, France
Organization:
Study Overview
Official Title:
The Blood Patch in the Management of Intracranial Hypotension: Description of a Population and Professional Practices
Status:
RECRUITING
Status Verified Date:
2024-04
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:
BPIH
Brief Summary:
Intracranial hypotension results from leakage and/or hypotension of cerebrospinal fluid. It can be spontaneous or secondary to a dural puncture complicating perimedullary anesthesia or a lumbar puncture. The incidence remains low with less than 1% post spinal puncture (25 gauge needle), but is observed more frequently following a lumbar puncture, up to 36% with a 20 or 22 gauge needle. Accidental puncture of the dura mater with a 17 gauge needle used for epidural anesthesia is associated with postpuncture headaches in 75-80% of cases. Classically, symptoms appear 24 to 48 hours after the puncture and consist of very intense, postural, fronto-occipital headaches which may be associated with cranial nerve symptoms such as visual or hearing disturbances or vertigo. Among the risk factors are the size and type of the needle, age under 60 and female gender. About 90% of PDPH are self-limiting within 7-10 days.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: