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Clinical Trials in China / NCT06329635
Recruiting Not applicable

Treatment of Vasospasm of Aneurysmal Subarachnoid Hemorrhage With Intrathecal Nicardipine - FAST-IT Trial

NCT06329635 · tracked via the Priya Life Science China tracker
Sponsor
The Affiliated Hospital Of Guizhou Medical University
Phase
Not applicable
Started
2024-05-27
Last updated
2025-09-08

Condition(s) studied

Aneurysmal Subarachnoid HemorrhageVasospasm

Investigational drug(s) / intervention(s)

Intrathecal NicardipineNo intervention

Intrathecal Nicardipine: First, 6 ml of cerebrospinal fluid is withdrawn from the EVD or LD catheter, and then 4 ml (4mg) of nicardipine is injected into the EVD or LD drain tube, followed by 2 ml normal saline solution, and then the EVD or LD tube is clamped for 2 hours, and then kept open as clinically necessary until the next dose (q12h) of medication.

No intervention: A simulated "intrathecal administration" operation is performed by a dedicated physician who is unblinded to the group assignment, the EVD or LD tube is not opened, and no "drug" is given. The simulated administration process needs to be out of the patient's view (if awake patient) and out of the presence of study team personnel.

Study summary

To investigate whether patients with cerebral vasospasm associated with aneurysmal subarachnoid hemorrhage have a better prognosis with intrathecal nicardipine injection via extraventricular drainage or lumbar drainage.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (28)

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

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06329635 on ClinicalTrials.gov ↗ ← All trials in China