Lumbar Drain With Intrathecal Nicardipine in Aneurysmal Subarachnoid Hemorrhage
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Normal Saline, Nicardipine.
- Who it may be relevant to
- Registry conditions: Subarachnoid Hemorrhage. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Prophylactic Use of Intrathecal Calcium Channel Antagonist Through Lumbar Drain in Patients With Subarachnoid Hemorrhage Due to Aneurysmal Rupture
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.
Detailed 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.
Interventions
- Drug Normal Saline
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. - Drug Nicardipine
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 outcome measures
- Incidence of Vasospasm [Time frame: up to hospitalization day 21]
- Incidence of Delayed Cerebral Ischemia [Time frame: up to hospitalization day 21]
Secondary outcome measures (2)
- Modified Rankin Scale Score [Time frame: month 6]
- Incidence of Meningitis [Time frame: up to hospitalization day 21]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Advocate Lutheran General Hospital — Park Ridge
Identifiers
NCT: NCT07246629 · IRB00139639