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
- Are there results?
- Not yet: the study is under way
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.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- 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
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Use of Intrathecal Calcium Channel Antagonist Through Lumbar Drain in Patients With Subarachnoid Hemorrhage Due to Aneurysmal Rupture
- ClinicalTrials.gov ID
- NCT07246629
- Acronym / sponsor ID
- IRB00139639
- Conditions
- Subarachnoid Hemorrhage
- Keywords
- cerebral aneurysm, intrathecal nicardipine, vasospasm
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 214 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Jan 2027 (estimated)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 24 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Sham comparator | Drug: Normal Salinestandard treatment of cerebral vasospasm and sham injection of 10 mL preservative-free normal saline in luer-lock sterile syringe |
| Standard of Care Plus Nicardipine | Experimental | Drug: Nicardipinestandard treatment of cerebral vasospasm with prophylactic administration of intrathecal nicardipine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Normal Saline10 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 | Standard of Care |
| NicardipineNicardipine 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. | Drug | Standard of Care Plus Nicardipine |
Primary outcome
Incidence of Vasospasm
Time frame: 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
Time frame: 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
2 secondary outcomes
Modified Rankin Scale Score
Time frame: month 6
Incidence of Meningitis
Time frame: up to hospitalization day 21
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Krishna Joshi, MD principal investigator
Advocate Lutheran General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sajid Suriya, MD (847-723-2078, Sajid.suriya@aah.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Vasospasm (time frame: up to hospitalization day 21). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.