Lumbar Drain With Intrathecal Nicardipine in Aneurysmal Subarachnoid Hemorrhage

Part of paid clinical trials in Park Ridge, Illinois.

Sponsor
Wake Forest University Health Sciences
Study ID
NCT07246629
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Subarachnoid Hemorrhage

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Normal Saline — DRUG
    10 mL preservative-free normal saline in luer-lock sterile syringe every 24 hours from randomization through day 14 post-bleed or lumbar drain removal, whichever occurs first.
  • Nicardipine — DRUG
    Nicardipine 4 mg will be diluted in preservative-free normal saline to 10 mL in luer-lock sterile syringe every 24 hours from randomization through day 14 post-bleed or lumbar drain removal, whichever occurs first.

Study Details

The purpose of this study is to determine the effectiveness of prophylactic administration of intra-thecal nicardipine though lumbar cerebrospinal fluid drain in prevention of symptomatic vasospasm in patients with subarachnoid hemorrhage due to rupture of cerebral aneurysms.

Key Dates

Start date
Jun 30, 2026
Status verified
Apr 2026
Primary completion
Jan 31, 2027
Completion
Jan 31, 2027

Study Design

Enrollment
214 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Sham Comparator: Standard of Care
    standard treatment of cerebral vasospasm and sham injection of 10 mL preservative-free normal saline in luer-lock sterile syringe
  • Experimental: Standard of Care Plus Nicardipine
    standard treatment of cerebral vasospasm with prophylactic administration of intrathecal nicardipine

Primary Outcome Measure

Incidence of Vasospasm [ Time Frame: up to hospitalization day 21 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Advocate Lutheran General HospitalPark RidgeIllinois60068
Sajid Suriya, MD
847-723-2078

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