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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
214
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.
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.
Advocate Lutheran General Hospital
Park Ridge, Illinois, United States
Incidence of Vasospasm
The incidence of symptomatic clinical or radiographic vasospasm in patients treated with prophylactic administration of intrathecal nicardipine though lumbar drain
Time frame: up to hospitalization day 21
Incidence of Delayed Cerebral Ischemia
The incidence of symptomatic clinical or radiographic delayed cerebral ischemia in patients treated with prophylactic administration of intrathecal nicardipine though lumbar drain
Time frame: up to hospitalization day 21
Modified Rankin Scale Score
The Modified Rankin Scale is a clinical tool used to assess the functional disability after a stroke. It is a six-point ordinal scale that measures the patient's ability to perform activities of daily living. Score Range: 0 no symptoms, 1 no significant disability, 2 slight disability, 3 moderate disability, 4 moderately severe disability, 5 severe disability, 6 dead.
Time frame: month 6
Incidence of Meningitis
Incidence of meningitis as confirmed by clinical and laboratory findings
Time frame: up to hospitalization day 21
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