Lumbar Drain With Intrathecal Nicardipine in Aneurysmal Subarachnoid Hemorrhage

NCT07246629 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: IRB00139639
• Study Type: interventional
• Target: 214
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

cerebral aneurysm; intrathecal nicardipine; vasospasm

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Modified Rankin Scale Score

  month 6

• Incidence of Meningitis

  up to hospitalization day 21

Study Arms (2)

Standard of Care

SHAM COMPARATOR

standard treatment of cerebral vasospasm and sham injection of 10 mL preservative-free normal saline in luer-lock sterile syringe

Drug: Normal Saline

Standard of Care Plus Nicardipine

EXPERIMENTAL

standard treatment of cerebral vasospasm with prophylactic administration of intrathecal nicardipine

Drug: Nicardipine

Interventions

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.

Standard of Care Plus Nicardipine

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.

Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Advocate Lutheran General Hospital

Park Ridge, Illinois, 60068, United States

Location

MeSH Terms

Conditions

Subarachnoid Hemorrhage; Intracranial Aneurysm

Interventions

Saline Solution; Nicardipine

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intracranial Arterial Diseases; Aneurysm

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Krishna Joshi, MD

  Advocate Lutheran General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sajid Suriya, MD

CONTACT

847-723-2078; Sajid.suriya@aah.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 24, 2025
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)