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 — DRUG10 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 — DRUGNicardipine 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 Carestandard treatment of cerebral vasospasm and sham injection of 10 mL preservative-free normal saline in luer-lock sterile syringe
- Experimental: Standard of Care Plus Nicardipinestandard 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
- Sajid Suriya, MD847-723-2078
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Advocate Lutheran General Hospital | Park Ridge | Illinois | 60068 |
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