Study Comparing Intrathecal Nicardipine Injection Methods for Treating Vasospasm in Aneurysmal Subarachnoid Hemorrhage Patients

What this Trial Is About

Researchers are evaluating whether injecting nicardipine directly into the cerebrospinal fluid improves outcomes for patients with cerebral vasospasm caused by aneurysmal subarachnoid hemorrhage. This multi-center, prospective, double-blinded, randomized controlled trial compares two methods of delivering nicardipine through extraventricular drainage EVD or lumbar drainage LD. The study aims to determine which approach leads to a better prognosis for affected patients. Participants in the treatment group receive intrathecal nicardipine injections via EVD or LD catheters. The process involves withdrawing 6 ml of cerebrospinal fluid, injecting 4 ml 4 mg of nicardipine hydrochloride, followed by 2 ml of saline, then clamping the catheter for 2 hours. This dosing is done twice daily. The control group undergoes a simulated procedure without receiving the drug. The drainage tubes remain open as clinically needed between doses. During the study, participants are monitored for outcomes using multiple scales, including the Modified Rankin Scale at 90 and 365 days, Glasgow Outcome Score, MMSE, NIH Stroke Scale, and rates of complications like infections or hemorrhage. Safety is assessed through adverse event tracking. Follow-up visits occur up to one year after treatment. The entire study period spans from the start of treatment to long-term outcome evaluations.

Treatment of Vasospasm of Aneurysmal Subarachnoid Hemorrhage With Intrathecal Nicardipine - FAST-IT Trial