Nicardipine for Subarachnoid Hemorrhage
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether nicardipine, administered directly into the spinal fluid (intrathecal administration), can prevent blood vessel spasms in individuals who have experienced a subarachnoid hemorrhage (a type of brain bleeding due to a burst blood vessel). Participants will receive either standard care plus nicardipine or standard care with a placebo. The study seeks individuals who have had a brain hemorrhage from a burst aneurysm, have a specific score indicating their condition isn't too severe, and have or will have a lumbar drain placed. As a Phase 4 trial, this research aims to understand how an FDA-approved and proven effective treatment can benefit more patients.
Do I need to stop my current medications for this trial?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What is the safety track record for intrathecal nicardipine?
Research has shown that intrathecal nicardipine is generally safe for treating cerebral vasospasm, a condition where blood vessels in the brain tighten, often after a brain bleed. In previous studies, most patients tolerated intrathecal nicardipine well. For instance, one study found that only 8.4% of patients required additional treatment for vasospasm after receiving this medication.
However, some side effects occur. The most common reported side effect was increased pressure inside the skull, known as intracranial hypertension. About 75.8% of patients who received intrathecal nicardipine experienced this, compared to 68.2% who did not receive it. While this side effect is common, weighing the benefits of preventing vasospasm against the risks is important. Overall, the treatment has demonstrated potential benefits and safety for patients with subarachnoid hemorrhage, a type of brain bleed.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about intrathecal nicardipine for treating subarachnoid hemorrhage because it offers a novel delivery method directly to the cerebrospinal fluid, potentially enhancing its effectiveness against cerebral vasospasm. Unlike traditional treatments that are administered systemically, this approach targets the affected area more precisely, which may reduce side effects and improve outcomes. Additionally, by delivering nicardipine directly to the site of action, there is potential for faster relief from symptoms associated with subarachnoid hemorrhage, setting it apart from standard treatments like oral or intravenous calcium channel blockers.
What evidence suggests that intrathecal nicardipine might be an effective treatment for subarachnoid hemorrhage?
Research has shown that injecting nicardipine into the spine can help reduce cerebral vasospasm, a common issue following a subarachnoid hemorrhage (SAH) from a burst aneurysm. This trial will compare two treatment approaches: one group will receive the standard treatment of cerebral vasospasm with a sham injection, while another group will receive the standard treatment plus prophylactic administration of intrathecal nicardipine. Previous studies have demonstrated that nicardipine improves blood flow by relaxing the arteries, which can enhance survival chances. Specifically, one study reported that 65.5% of patients experienced a good recovery three months after receiving this treatment. Another study found that nicardipine safely and effectively reduced artery spasms and improved patient outcomes. Overall, strong evidence supports the effectiveness of spinal nicardipine in managing complications after SAH.14678
Who Is on the Research Team?
Krishna Joshi, MD
Principal Investigator
Advocate Lutheran General Hospital
Are You a Good Fit for This Trial?
This trial is for patients who have had a subarachnoid hemorrhage—a type of stroke caused by bleeding into the space surrounding the brain—due to a ruptured brain aneurysm. Specific eligibility criteria are not provided, but typically participants must meet certain health conditions.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Prophylactic administration of intrathecal nicardipine through lumbar drain to prevent symptomatic vasospasm
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of functional disability using the Modified Rankin Scale
What Are the Treatments Tested in This Trial?
Interventions
- Intrathecal Nicardipine
Trial Overview
The study is testing whether giving nicardipine directly into the spinal fluid can prevent blood vessel spasms in patients who've had a subarachnoid hemorrhage. Nicardipine is compared with normal saline (saltwater solution).
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
standard treatment of cerebral vasospasm with prophylactic administration of intrathecal nicardipine
standard treatment of cerebral vasospasm and sham injection of 10 mL preservative-free normal saline in luer-lock sterile syringe
Find a Clinic Near You
Who Is Running the Clinical Trial?
Wake Forest University Health Sciences
Lead Sponsor
Citations
Intrathecal nicardipine for cerebral vasospasm after non- ...
Intrathecal nicardipine may be an effective therapeutic option for reducing the severity of vasospasm and improving mortality rates in patients with non- ...
Safety and efficacy of intrathecal nicardipine for ...
Cerebral vasospasm remains an expected and difficult complication to treat related to aneurysmal SAH. Intrathecal nicardipine appears to be a safe and effective ...
Does intrathecal nicardipine for cerebral vasospasm following ...
IT nicardipine led to a rapid and lasting improvement in arterial transcranial Doppler velocities.
Localized Nicardipine Release Implants for Prevention of ...
These findings show that nicardipine implants may safely and effectively reduce angiographic vasospasm and may improve clinical outcomes after aSAH.
Abstract 65: Intrathecal Nicardipine for Cerebral ...
In this cohort, 65.5% had a favorable functional outcome (mRS≤2) at 90 days. Conclusions: In a retrospective analysis, off-label IT Nicardipine ...
Evaluating the Effects of Intrathecal Nicardipine ...
This study aimed to determine the impact of intrathecal (IT) nicardipine on outcomes in patients with aneurysmal subarachnoid hemorrhage (aSAH) ...
Effectiveness of intrathecal nicardipine on cerebral ...
The studies indicate that intrathecal nicardipine has shown potential benefits and safety in the treatment of cerebral vasospasm. Conclusions: Although ...
8.
journals.lww.com
journals.lww.com/ccmjournal/abstract/2013/12001/921__safety_of_intrathecal_nicardipine_for.877.aspx921: Safety of intrathecal nicardipine for vasospasm due to ...
The most common adverse effect noted in the safety analysis was intracranial hypertension, 75.8% in the IT nicardipine group vs. 68.2% in the control group (p= ...
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