Subarachnoid Hemorrhage
Conditions
Keywords
cerebral aneurysm, intrathecal nicardipine, vasospasm
Brief 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.
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
DRUGNormal 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.
DRUGNicardipine
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.
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Vasospasm | up to hospitalization day 21 | The incidence of symptomatic clinical or radiographic vasospasm in patients treated with prophylactic administration of intrathecal nicardipine though lumbar drain |
| Incidence of Delayed Cerebral Ischemia | up to hospitalization day 21 | The incidence of symptomatic clinical or radiographic delayed cerebral ischemia in patients treated with prophylactic administration of intrathecal nicardipine though lumbar drain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Modified Rankin Scale Score | month 6 | 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. |
| Incidence of Meningitis | up to hospitalization day 21 | Incidence of meningitis as confirmed by clinical and laboratory findings |
Countries
United States
Contacts
CONTACTSajid Suriya, MD
PRINCIPAL_INVESTIGATORKrishna Joshi, MD
Advocate Lutheran General Hospital
Outcome results
None listed