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

Sponsor
The Affiliated Hospital Of Guizhou Medical University
Study ID
NCT06329635
Status
Recruiting
Apply to this trial

Conditions

  • Aneurysmal Subarachnoid Hemorrhage
  • Vasospasm

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Intrathecal Nicardipine — DRUG
    First, 6 ml of cerebrospinal fluid is withdrawn from the EVD or LD catheter, and then 4 ml (4mg) of nicardipine is injected into the EVD or LD drain tube, followed by 2 ml normal saline solution, and then the EVD or LD tube is clamped for 2 hours, and then kept open as clinically necessary until the next dose (q12h) of medication.
  • No intervention — OTHER
    A simulated "intrathecal administration" operation is performed by a dedicated physician who is unblinded to the group assignment, the EVD or LD tube is not opened, and no "drug" is given. The simulated administration process needs to be out of the patient's view (if awake patient) and out of the presence of study team personnel.

Study Details

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.

Key Dates

Start date
May 27, 2024
Status verified
Sep 2025
Primary completion
May 31, 2026
Completion
May 31, 2026

Study Design

Enrollment
396 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Intrathecal Treatment Group
    The participants in the IT treatment group will be treated with intrathecal nicardipine injection through EVD or LP draining catheter.
  • Sham Comparator: Control Group
    The participants of the control group will receive no intrathecal nicardipine injection through EVD or LP draining catheter.

Primary Outcome Measure

Dichotomized Modified Rankin Scale (mRS) 0-2 vs 3-6 [ Time Frame: Day 90±30, Day 365±60. ]

Central Contacts

Related Studies