Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06457347
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-13
First Post:
2024-05-25
Brief Title:
Early Versus Ultra Early Surgical Treatment of Ruptured Intracranial Aneurysms
Sponsor:
Revaz Dzhindzhikhadze
Organization:
Moscow Regional Research and Clinical Institute MONIKI
Study Overview
Official Title:
Early Versus Ultra Early Surgical Treatment of Ruptured Intracranial Aneurysms A Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
The goal of this clinical trial is to determine the most effective timing for clipping in adults with ruptured intracranial aneurysms It will also assess the safety of performing the surgery at different times of early period after the aneurysm has ruptured The main questions it aims to answer are
1 Does ultra-early surgical intervention less than 24 hours of rupture improve survival rates compared to delayed surgery 24 to 72 hours after rupture
2 What are the complication rates associated with early versus delayed surgical intervention
Researchers will compare clipping in ultra-early period to surgery in early period to see if timing affects the outcomes for treating ruptured intracranial aneurysms
Participants will
Be randomly assigned to undergo surgical clipping either within 24 hours of rupture or between 24 hours to 72 hours after the rupture
Visit the clinic for follow-up assessments at 1 month 3 months 6 months and 12 months post-surgery
Keep a diary of their symptoms neurological function and any complications they experience post-surgery
1 Does ultra-early surgical intervention less than 24 hours of rupture improve survival rates compared to delayed surgery 24 to 72 hours after rupture
2 What are the complication rates associated with early versus delayed surgical intervention
Researchers will compare clipping in ultra-early period to surgery in early period to see if timing affects the outcomes for treating ruptured intracranial aneurysms
Participants will
Be randomly assigned to undergo surgical clipping either within 24 hours of rupture or between 24 hours to 72 hours after the rupture
Visit the clinic for follow-up assessments at 1 month 3 months 6 months and 12 months post-surgery
Keep a diary of their symptoms neurological function and any complications they experience post-surgery
Detailed Description:
None
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