A Phase 4 interventional study of Normal Saline and Nicardipine in Subarachnoid Hemorrhage, sponsored by Wake Forest University Health Sciences. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-01.
Sponsored by Wake Forest University Health Sciences · Phase 4, Interventional, and Prevention
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.
509 studies on the registry are indexed under Subarachnoid Hemorrhage; 124 are open to participants now.
This study's planned enrollment of 214 is above the median of 52 across 263 interventional studies indexed under Subarachnoid Hemorrhage.
Browse Subarachnoid Hemorrhage studies →Wake Forest University Health Sciences is the lead sponsor of 1,320 studies on the registry; 199 are open to participants now.
Of its 323 completed or terminated interventional studies of FDA-regulated products, 243 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
standard treatment of cerebral vasospasm and sham injection of 10 mL preservative-free normal saline in luer-lock sterile syringe
Drug: Normal Saline
standard treatment of cerebral vasospasm with prophylactic administration of intrathecal nicardipine
Drug: Nicardipine
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.
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
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Wake Forest University Health Sciences