Lumbar Drain With Intrathecal Nicardipine in Aneurysmal Subarachnoid Hemorrhage

Wake Forest University (WFU)

Status and phase: Not yet enrolling; Phase 4

Conditions: Subarachnoid Hemorrhage

Treatments: Drug: Nicardipine; Drug: Normal Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT07246629

IRB00139639

Details and patient eligibility

About

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.

Full 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.

Enrollment: 214 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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214 participants in 2 patient groups

Standard of Care

Sham Comparator group

Description:

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

Treatment:

Drug: Normal Saline

Standard of Care Plus Nicardipine

Experimental group

Description:

standard treatment of cerebral vasospasm with prophylactic administration of intrathecal nicardipine

Treatment:

Drug: Nicardipine