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NCT Number: NCT07246629

Lumbar Drain With Intrathecal Nicardipine in Aneurysmal Subarachnoid Hemorrhage

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Advocate Lutheran General Hospital

Park Ridge, Illinois, 60068, United States

Location contact

Sajid Suriya, MD

CONTACT

[email protected]

847-723-2078

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Incidence of Vasospasm

    Time frame: up to hospitalization day 21

    The incidence of symptomatic clinical or radiographic vasospasm in patients treated with prophylactic administration of intrathecal nicardipine though lumbar drain

  2. Incidence of Delayed Cerebral Ischemia

    Time frame: up to hospitalization day 21

    The incidence of symptomatic clinical or radiographic delayed cerebral ischemia in patients treated with prophylactic administration of intrathecal nicardipine though lumbar drain

Secondary outcomes

  1. Modified Rankin Scale Score

    Time frame: month 6

    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.

  2. Incidence of Meningitis

    Time frame: up to hospitalization day 21

    Incidence of meningitis as confirmed by clinical and laboratory findings

Study contacts

Contact information is provided by the study sponsor or research team.

Sajid Suriya, MD

CONTACT

[email protected]

847-723-2078

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Nov 24, 2025
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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