Subarachnoid HemorrhagePhase 4NCT07246629
Lumbar Drain With Intrathecal Nicardipine in Aneurysmal Subarachnoid Hemorrhage
A Phase 4 study testing Normal Saline and Nicardipine in people with Subarachnoid Hemorrhage, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subarachnoid Hemorrhage
- What is being tested?
- Normal Saline and Nicardipine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 214 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2027to Mar 2028
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Advocate Lutheran General Hospital
Park Ridge, Illinois, 60068
Sajid Suriya, MD, 847-723-2078, Sajid.suriya@aah.org
About this study
Official title: Prophylactic Use of Intrathecal Calcium Channel Antagonist Through Lumbar Drain in Patients With Subarachnoid Hemorrhage Due to Aneurysmal Rupture
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.
Read the 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.
- Conditions
- Subarachnoid Hemorrhage
- Being tested
- Normal Saline, Nicardipine
- Keywords
- cerebral aneurysm, intrathecal nicardipine, vasospasm
- Medical subject headings
- Subarachnoid Hemorrhage, Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal SalineDrug
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.
NicardipineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Sham comparator | standard treatment of cerebral vasospasm and sham injection of 10 mL preservative-free normal saline in luer-lock sterile syringe Receives: Drug: Normal Saline |
| Standard of Care Plus Nicardipine | Experimental | standard treatment of cerebral vasospasm with prophylactic administration of intrathecal nicardipine Receives: Drug: Nicardipine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Vasospasm
The incidence of symptomatic clinical or radiographic vasospasm in patients treated with prophylactic administration of intrathecal nicardipine though lumbar drain
Measured: 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
Measured: up to hospitalization day 21
Secondary outcomes (2)
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.
Measured: month 6
Incidence of Meningitis
Incidence of meningitis as confirmed by clinical and laboratory findings
Measured: up to hospitalization day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study startJan 2027 (estimated)
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subarachnoid HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 214 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Krishna Joshi, MD, Principal investigator, Advocate Lutheran General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07246629
- Sponsor's protocol ID
- IRB00139639
- Status last verified
- Sep 2026
- First submitted
- 17 Nov 2025
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No