Using intrathecal nicardipine to treat vasospasm after aneurysmal subarachnoid hemorrhage

Trial of Treatment of Vasospasm Associated With Aneurysmal Subarachnoid Hemorrhage With Intrathecal Injection of Nicardipine: a Multi-center, Prospective, Double-blinded, Randomized Controlled Trial

This study is testing if giving nicardipine directly into the spine can help patients with vasospasm after a brain bleed feel better compared to regular treatment.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 396 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: The Affiliated Hospital Of Guizhou Medical University (Academic / other)
• Locations: 28 sites (Hefei, Anhui and 27 other locations)
• Trial ID: NCT06329635 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of intrathecal nicardipine injections in patients experiencing cerebral vasospasm due to aneurysmal subarachnoid hemorrhage. The study employs a multi-center, prospective, double-blinded, randomized controlled design, where participants receive nicardipine via either extraventricular drainage or lumbar drainage. The treatment involves withdrawing cerebrospinal fluid followed by the injection of nicardipine and saline, with monitoring for clinical outcomes. The goal is to determine if this approach improves patient prognosis compared to standard care.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-80 who have experienced spontaneous subarachnoid hemorrhage and have evidence of vasospasm.

Not a fit: Patients who do not have a confirmed diagnosis of vasospasm or are outside the age range may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve outcomes for patients suffering from vasospasm after subarachnoid hemorrhage.

How similar studies have performed: While similar approaches have been explored, this specific method of intrathecal nicardipine administration is novel and has not been extensively tested in prior studies.

Eligibility criteria

Inclusion criteria:

1. Age 18-80.
2. Spontaneous SAH confirmed by head CT.
3. Saccular brain aneurysm is identified and treated, either surgically or endovascularly.
4. SAH Fisher grade \>1 or modified Fisher grade \>0.
5. EVD placed for acute hydrocephalus, or LD placed for draining bloody CSF as deemed necessary by the treating physician.
6. Any clinical scenario leading to the diagnosis of possible vasospasm, which includes:

   1. Mean flow velocity of MCA \>120, or Lindegaard Ratio ( LR ) \> 3.
   2. Any intracranial artery including MCA, ACA, PCA, and BA, TCD showed an upward trend of mean flow velocity for 2 consecutive days (\>25cm/s/day).
   3. Clinical deterioration including mental status change (GCS score decrease \> 2) and focal neurological deficit unable to be attributed to other known neurological reasons.
   4. Evidence of vasospasm on CTA or DSA, or ischemic change by CTP, MRI.
7. Within 14 days of onset of SAH.
8. Informed consent obtained from the patient or family member.

Exclusion criteria:

1. Hunt-Hess Grade 5 or WFNS Grade 5 (no clinical improvement after EVD placement for acute hydrocephalus).
2. Bacterial or distal aneurysms without subarachnoid hemorrhage in the basal cisterns.
3. The treating physician determines that the culprit aneurysm has not been fully repaired, with a very high likelihood of rebleeding in the near term.
4. History of head trauma within the past 3 months.
5. Any recent brain disease within 3 months, such as tumors, stroke, epilepsy, vasculitis, arteriovenous malformation, hydrocephalus, etc.
6. History of psychiatric disorders or seizures within 3 months.
7. Severe concurrent medical conditions.
8. Pregnant women or those of childbearing potential with a positive urine or serum β-human chorionic gonadotropin (HCG) test.
9. Lactating women.
10. Life expectancy of less than 1 year prior to aSAH onset.
11. Pre-morbid mRS score \>1.
12. Participation in another randomized clinical trial that may confound the evaluation of this study.

Where this trial is running

Hefei, Anhui and 27 other locations

• Affiliated First Hospital of Anhui Medical University — Hefei, Anhui, China (Recruiting)
• Beijing Tiantan Hospital, Affiliated to Capital Medical University — Beijing, Beijing Municipality, China (Recruiting)
• Chongqing Ninth People's Hospital — Chongqing, Chongqing Municipality, China (Recruiting)
• Southern Medical University Zhujiang Hospital — Guangzhou, Guangdong, China (Recruiting)
• Affiliated South China Hospital of Shenzhen University — Shenzhen, Guangdong, China (Recruiting)
• Nanning First People's Hospital — Nanning, Guangxi, China (Recruiting)
• Jinyang Hospital Affiliated to Guizhou Medical University — Guiyang, Guizhou, China (Recruiting)
• The Second Affiliated Hospital of Guizhou Medical University — Kaili, Guizhou, China (Recruiting)
• Liupanshui City People's Hospital — Liupanshui, Guizhou, China (Recruiting)
• People's Hospital of Qiannan Buyi and Miao Autonomous Prefecture, Guizhou Province — Xingyi, Guizhou, China (Recruiting)
• Qianxinan Prefecture People's Hospital — Xingyi, Guizhou, China (Recruiting)
• Xingyi City People's Hospital — Xingyi, Guizhou, China (Recruiting)
• Qianfengdong Prefecture People's Hospital — Kaili, G, China (Recruiting)
• The Second Hospital of Hebei Medical University — Shijiazhuang, Hebei, China (Recruiting)
• Nanyang Central Hospital, Henan Province — Nanyang, Henan, China (Recruiting)
• Baotou Central Hospital — Baotou, Inner Mongolia, China (Recruiting)
• Changzhou First People's Hospital — Changzhou, Jiangsu, China (Recruiting)
• The First People's Hospital of Zhenjiang City, Jiangsu Province — Zhenjiang, Jiangsu, China (Recruiting)
• Ganzhou People's Hospital — Ganzhou, Jiangxi, China (Recruiting)
• Jinggangshan University Affiliated Hospital — Ji’an, Jiangxi, China (Recruiting)
• Taian Central Hospital, Shandong Province — Tai’an, Shandong, China (Recruiting)
• Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai Municipality, China (Recruiting)
• The First Hospital of Shanxi Medical University — Taiyuan, Shanxi, China (Recruiting)
• West China Airport Hospital of Sichuan University — Chengdu, Sichuan, China (Recruiting)
• Western Medical University Affiliated Hospital — Luzhou, Sichuan, China (Recruiting)
• The First Affiliated Hospital of Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Recruiting)
• Zhejiang Hospital — Hangzhou, Zhejiang, China (Recruiting)
• The Second Affiliated Hospital of Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Principal investigator: Zeguang Ren — The Affiliated Hospital Of Guizhou Medical University
• Study coordinator: Guangtang Chen, MD

Conditions Aneurysmal Subarachnoid Hemorrhage; Vasospasm; Delayed cerebral ischemia; Nicardipine; Intrathecal injection