Lumbar Drain With Intrathecal Nicardipine in Aneurysmal Subarachnoid Hemorrhage

This study is looking at whether giving nicardipine (a medication) directly into the spinal fluid can help prevent problems after a subarachnoid hemorrhage (bleeding in the space around the brain, often from a burst aneurysm). You might be able to join if you are at least 18 years old, have had this type of bleeding with a specific severity (Hunt and Hess score 3 or less), and have a lumbar drain (a small tube in your lower back to drain spinal fluid) in place or planned. The study aims to see if nicardipine can reduce vasospasm (narrowing of blood vessels in the brain) and delayed cerebral ischemia (brain injury due to reduced blood flow). The current status of this study is unclear.

Study design
This is a triple-blinded, randomized study involving about 214 participants. Participants will either receive nicardipine or a saline solution through their lumbar drain.
What's involved
Participants will receive either nicardipine or normal saline every 24 hours from randomization through day 14 post-bleed or until their lumbar drain is removed, whichever comes first.
Compensation
Not stated in the trial record.
Follow-up
The study will measure outcomes like vasospasm and delayed cerebral ischemia up to hospitalization day 21.

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NCT07246629

Lumbar Drain With Intrathecal Nicardipine in Aneurysmal Subarachnoid Hemorrhage

Not Yet Recruiting
PHASE4Ages 18+InterventionalPrevention
Wake Forest University Health Sciences
~214 participants
Updated 2026-07-30 on ClinicalTrials.gov
What's tested:Normal SalineNicardipine

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of Vasospasm
Measured over up to hospitalization day 21
+1 more outcome measured
Subarachnoid Hemorrhage
1 sites across 1 states
Illinois1
  • Krishna Joshi, MD · PRINCIPAL_INVESTIGATOR · Advocate Lutheran General Hospital

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Eligibility criteria

Inclusion

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

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
  • Incidence of Vasospasmup to hospitalization day 21

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

  • Incidence of Delayed Cerebral Ischemiaup 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