Using intrathecal nicardipine to treat vasospasm after aneurysmal subarachnoid hemorrhage

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Principal investigator: Zeguang Ren — The Affiliated Hospital Of Guizhou Medical University
• Study coordinator: Guangtang Chen, MD
• Email: 18286089635@163.com
• Phone: +8618286089635

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Nitric Oxide Use to Predict Vasospasm in Aneurysmal Subarachnoid Hemorrhage

  This study tests whether nitric oxide consumption in CSF can predict cerebral vasospasm in patients with aneurysmal SAH.

  Recruiting at 2 sites Massachusetts General Hospital · Boston, Massachusetts and 1 other locations · NCT07614906

• Multi-omics program to understand complications and outcomes after aneurysmal subarachnoid hemorrhage

  This project will test if combining blood, cerebrospinal fluid, urine, imaging, and multi-omics data can find biomarkers that predict complications and outcomes in adults with aneurysmal subarachnoid hemorrhage.

  Recruiting Beijing Tiantan Hospital · Beijing, Beijing Municipality · NCT07270419

• Dome-only coiling for severe aneurysmal subarachnoid hemorrhage

  This will test a minimally invasive dome-protection coiling procedure to prevent re-bleeding in adults who have had a severe aneurysmal subarachnoid hemorrhage.

  Recruiting University of Louisville · Louisville, Kentucky · NCT07250958

• Cilostazol to help prevent delayed brain ischemia after aneurysm bleed

  This study tests whether cilostazol can reduce delayed brain ischemia and improve outcomes after aneurysmal subarachnoid hemorrhage in adults who had recent aneurysm treatment.

  Recruiting Phase 3 Beijing Tiantan Hospital · Beijing, Beijing Municipality · NCT07249853

• Transcutaneous Vagal Nerve Stimulation to help with brain vessel narrowing after aneurysm rupture

  This trial tests whether using a noninvasive nerve stimulation device can reduce cerebral vasospasm after an aneurysmal brain bleed in adults 18–65 who are undergoing standard treatment.

  Recruiting University of Alabama at Birmingham · Birmingham, Alabama · NCT07131696

• Tocilizumab-aazg to reduce stroke risk after a ruptured brain aneurysm

  This trial will try to see if a single IV dose of tocilizumab-aazg is safe and can help prevent delayed strokes in adults who have had a ruptured brain aneurysm (aneurysmal subarachnoid hemorrhage).

  Recruiting Phase 1 University of Florida · Gainesville, Florida · NCT06863480

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.