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Not yet recruiting Phase 4 NCT07246629

Lumbar Drain With Intrathecal Nicardipine in Aneurysmal Subarachnoid Hemorrhage

Phase 4 – monitoring after market approval
Conditions: Subarachnoid Hemorrhage

Sponsor: Wake Forest University Health Sciences

trial.available_in: БГ
Overview
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.
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.
Who can participate
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
Interventions
Normal Saline
DRUG
Nicardipine
DRUG
Locations 1
United States (1)
Advocate Lutheran General Hospital
Park Ridge , Illinois
Technical details
Status
Not yet recruiting
Phase
Phase 4
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
01.06.2026
Completion date
01.01.2027
Registry ID
NCT07246629
Source
clinicaltrials.gov
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