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NCT07246629
Lumbar Drain With Intrathecal Nicardipine in Aneurysmal Subarachnoid Hemorrhage
Conditions: Subarachnoid Hemorrhage
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE4
Enrollment: 214
Sponsor: Wake Forest University Health Sciences
Location: Advocate Lutheran General Hospital Park Ridge Illinois
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07246629). StuddyBuddy aggregates publicly available trial information.