Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06510842
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-08
Brief Title:
Lumbar Drainage of Intraventricular Hemorrhage
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Lumbar Drainage of Intraventricular Hemorrhage The DRAIN IVH Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DRAIN IVH
Brief Summary:
Intracerebral hemorrhage ICH is a debilitating and fatal disease especially when the hemorrhage is also entering the cerebral ventricles leading to acute hydrocephalus In these cases patients need a drainage through external ventricular drains EVD In the longer term patients often need a permanent ventriculoperitoneal VP shunt to avoid hydrocephalus Here we hypothesize that the early insertion of a lumbar drainage in addition to the EVD could lead to better functional outcome and avoidance of VP shunting by drainage of the blood which promotes inflammatory and adverse effects in the subarachnoid space For that we propose a multi-center randomized clinical trial to investigate the hypothesis
Detailed Description:
None
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