Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06329635
Status:
RECRUITING
Last Update Posted:
2024-05-30
First Post:
2024-03-19
Brief Title:
Treatment of Vasospasm of Aneurysmal Subarachnoid Hemorrhage With Intrathecal Nicardipine - FAST-IT Trial
Sponsor:
The Affiliated Hospital Of Guizhou Medical University
Organization:
The Affiliated Hospital Of Guizhou Medical University
Study Overview
Official Title:
Trial of Treatment of Vasospasm Associated With Aneurysmal Subarachnoid Hemorrhage With Intrathecal Injection of Nicardipine a Multi-center Prospective Double-blinded Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-05
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:
None
Brief Summary:
To investigate whether patients with cerebral vasospasm associated with aneurysmal subarachnoid hemorrhage have a better prognosis with intrathecal nicardipine injection via extraventricular drainage or lumbar drainage
Detailed Description:
Objective
To investigate whether patients with cerebral vasospasm associated with aneurysmal subarachnoid hemorrhage have a better prognosis with intrathecal nicardipine injection via extraventricular drainage or lumbar drainage
Design
This study is a multi-center prospective double-blinded randomized controlled trial
Interventions
First 6 ml of cerebrospinal fluid is withdrawn from the EVD or LD catheter and then 4 ml of nicardipine hydrochloride is injected into the EVD or LD drain tube followed by 2 ml of 09 sodium chloride solution NaCl and then the EVD or LD tube was clamped for 2 hours after the injection was completed then kept open as clinically necessary until the next dose twice a day
To investigate whether patients with cerebral vasospasm associated with aneurysmal subarachnoid hemorrhage have a better prognosis with intrathecal nicardipine injection via extraventricular drainage or lumbar drainage
Design
This study is a multi-center prospective double-blinded randomized controlled trial
Interventions
First 6 ml of cerebrospinal fluid is withdrawn from the EVD or LD catheter and then 4 ml of nicardipine hydrochloride is injected into the EVD or LD drain tube followed by 2 ml of 09 sodium chloride solution NaCl and then the EVD or LD tube was clamped for 2 hours after the injection was completed then kept open as clinically necessary until the next dose twice a day
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?:
False
Is an FDA AA801 Violation?:
None