Treatment of Vasospasm of Aneurysmal Subarachnoid Hemorrhage With Intrathecal Nicardipine - FAST-IT Trial
NCT ID: NCT06329635
Last Updated: 2025-09-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
396 participants
INTERVENTIONAL
2024-05-27
2026-05-31
Brief Summary
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Detailed Description
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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.
Design:
This study is a multi-center, prospective, double-blinded, randomized controlled trial.
Interventions:
First, 6 ml of cerebrospinal fluid is withdrawn from the EVD or LD catheter, and then 4 ml of nicardipine hydrochloride is injected into the EVD or LD drain tube, followed by 2 ml of 0.9 % sodium chloride solution (NaCl), and then the EVD or LD tube was clamped for 2 hours after the injection was completed, then kept open as clinically necessary until the next dose (twice a day).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Intrathecal Treatment Group
The participants in the IT treatment group will be treated with intrathecal nicardipine injection through EVD or LP draining catheter.
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First, 6 ml of cerebrospinal fluid is withdrawn from the EVD or LD catheter, and then 4 ml (4mg) of nicardipine is injected into the EVD or LD drain tube, followed by 2 ml normal saline solution, and then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.
Control Group
The participants of the control group will receive no intrathecal nicardipine injection through EVD or LP draining catheter.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
80 Years
ALL
No
Sponsors
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The Affiliated Hospital Of Guizhou Medical University
OTHER
Responsible Party
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Zeguang Ren
Principal Investigator
Principal Investigators
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Zeguang Ren
Role: PRINCIPAL_INVESTIGATOR
Affiliated Hospital of Guizhou Medical University
Locations
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Affiliated First Hospital of Anhui Medical University
Hefei, Anhui, China
Beijing Tiantan Hospital, Affiliated to Capital Medical University
Beijing, Beijing Municipality, China
Chongqing Ninth People's Hospital
Chongqing, Chongqing Municipality, China
Southern Medical University Zhujiang Hospital
Guangzhou, Guangdong, China
Affiliated South China Hospital of Shenzhen University
Shenzhen, Guangdong, China
Nanning First People's Hospital
Nanning, Guangxi, China
Jinyang Hospital Affiliated to Guizhou Medical University
Guiyang, Guizhou, China
The Second Affiliated Hospital of Guizhou Medical University
Kaili, Guizhou, China
Liupanshui City People's Hospital
Liupanshui, Guizhou, China
People's Hospital of Qiannan Buyi and Miao Autonomous Prefecture, Guizhou Province
Xingyi, Guizhou, China
Qianxinan Prefecture People's Hospital
Xingyi, Guizhou, China
Xingyi City People's Hospital
Xingyi, Guizhou, China
Qianfengdong Prefecture People's Hospital
Kaili, G, China
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Nanyang Central Hospital, Henan Province
Nanyang, Henan, China
Baotou Central Hospital
Baotou, Inner Mongolia, China
Changzhou First People's Hospital
Changzhou, Jiangsu, China
The First People's Hospital of Zhenjiang City, Jiangsu Province
Zhenjiang, Jiangsu, China
Ganzhou People's Hospital
Ganzhou, Jiangxi, China
Jinggangshan University Affiliated Hospital
Ji’an, Jiangxi, China
Taian Central Hospital, Shandong Province
Tai’an, Shandong, China
Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
The First Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
West China Airport Hospital of Sichuan University
Chengdu, Sichuan, China
Western Medical University Affiliated Hospital
Luzhou, Sichuan, China
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Zhejiang Hospital
Hangzhou, Zhejiang, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Jing Luo
Role: primary
Xiaolin Chen
Role: primary
Yi Huang
Role: primary
Chuanzhi Duan
Role: primary
Shihui, Du
Role: primary
Feng Wei
Role: primary
Qing Xiao
Role: primary
Yong Ni
Role: primary
Yi Ding
Role: primary
Yingwen Huang
Role: primary
Shiqiang Wang
Role: primary
Ming Gong
Role: primary
Jian Shen
Role: primary
Jianliang Wu
Role: primary
Shuai Dang
Role: primary
Ya Peng
Role: primary
Bo Chen
Role: primary
Qiuhua Jiang
Role: primary
Yongcheng Zhang
Role: primary
Xiao Chen
Role: primary
Bing Zhao
Role: primary
Geng Guo
Role: primary
Jun Lei
Role: primary
Jianhua Peng
Role: primary
Jianwei Pan
Role: primary
Shu Wan
Role: primary
Jianmin Zhang
Role: primary
References
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Other Identifiers
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2023070K
Identifier Type: -
Identifier Source: org_study_id
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