Lumbar Drain With Intrathecal Nicardipine in Aneurysmal Subarachnoid Hemorrhage
NCT07246629 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 214
Last updated 2026-04-24
Summary
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.
Conditions
- Subarachnoid Hemorrhage
Interventions
- DRUG
-
Normal Saline
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.
- DRUG
-
Nicardipine
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.
Sponsors & Collaborators
-
Wake Forest University Health Sciences
lead OTHER
Principal Investigators
-
Krishna Joshi, MD · Advocate Lutheran General Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-06-30
- Primary Completion
- 2027-01-31
- Completion
- 2027-01-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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