Lumbar Drain With Intrathecal Nicardipine in Aneurysmal Subarachnoid Hemorrhage

Prophylactic Use of Intrathecal Calcium Channel Antagonist Through Lumbar Drain in Patients With Subarachnoid Hemorrhage Due to Aneurysmal Rupture

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Subarachnoid Hemorrhage
• Intervention / Treatment: Drug: Normal Saline; Drug: Nicardipine

Detailed Description

This is a triple-blinded, prospective, sham, randomized study. The purpose of this research 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. Patients will be randomized to standard treatment of cerebral vasospasm with prophylactic administration of intrathecal nicardipine vs standard treatment alone. The medication used is FDA approved and will be used through an intra-thecal route through a lumbar drain which is indicated in patients with subarachnoid hemorrhage.

• Study Type: Interventional
• Enrollment (Estimated): 214
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Sajid Suriya, MD; Phone Number: 847-723-2078; Email: Sajid.suriya@aah.org

Study Locations

• United States
  • Illinois
    • Park Ridge, Illinois, United States, 60068
      • Advocate Lutheran General Hospital
      • Contact: Sajid Suriya, MD; Phone Number: 847-723-2078; Email: Sajid.suriya@aah.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age ≥18 years
• Aneurysmal subarachnoid hemorrhage with Hunt and Hess score 3 or less
• Patient or legal authorized representative available to sign the informed consent form
• Pre-morbid modified Rankin scale of 0 or 1.
• Patients who have lumbar drain placed or planned for cerebrospinal fluid diversion per standard of care
• Patients who are able to be randomized within 72 hours from arrival with aneurysmal subarachnoid hemorrhage or within 24 hours from lumbar drain placement

Exclusion Criteria:

• Pregnant females
• Subarachnoid hemorrhage (SAH) with hunt and hess scale of >3
• SAH due to etiology other than aneurysmal rupture
• Any contraindications in patients receiving calcium channel antagonists like hypersensitivity to dihydropyridines
• Active central nerve infection (CNS) infection or high suspicion of CNS infection
• Hemodynamic instability preventing the use of Nicardipine

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	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.
Experimental: Standard of Care Plus Nicardipine; standard treatment of cerebral vasospasm with prophylactic administration of intrathecal nicardipine	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Vasospasm	The incidence of symptomatic clinical or radiographic vasospasm in patients treated with prophylactic administration of intrathecal nicardipine though lumbar drain	up to hospitalization day 21
Incidence of Delayed Cerebral Ischemia	The incidence of symptomatic clinical or radiographic delayed cerebral ischemia in patients treated with prophylactic administration of intrathecal nicardipine though lumbar drain	up to hospitalization day 21

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Rankin Scale Score	The Modified Rankin Scale is a clinical tool used to assess the functional disability after a stroke. It is a six-point ordinal scale that measures the patient's ability to perform activities of daily living. Score Range: 0 no symptoms, 1 no significant disability, 2 slight disability, 3 moderate disability, 4 moderately severe disability, 5 severe disability, 6 dead.	month 6
Incidence of Meningitis	Incidence of meningitis as confirmed by clinical and laboratory findings	up to hospitalization day 21

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Krishna Joshi, MD, Advocate Lutheran General Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: November 17, 2025
• First Submitted That Met QC Criteria: November 17, 2025
• First Posted (Actual): November 24, 2025

Study Record Updates

• Last Update Posted (Actual): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 23, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: vasospasm; cerebral aneurysm; intrathecal nicardipine
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Hemorrhage; Intracranial Arterial Diseases; Aneurysm; Intracranial Hemorrhages; Pathological Conditions, Signs and Symptoms; Subarachnoid Hemorrhage; Intracranial Aneurysm; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pharmaceutical Preparations; Crystalloid Solutions; Isotonic Solutions; Solutions; Dihydropyridines; Nicardipine; Saline Solution
• Other Study ID Numbers: IRB00139639

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No