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Treatment of Vasospasm of Aneurysmal Subarachnoid Hemorrhage With Intrathecal Nicardipine - FAST-IT Trial
Sponsor: The Affiliated Hospital Of Guizhou Medical University
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.
Official title: Trial of Treatment of Vasospasm Associated With Aneurysmal Subarachnoid Hemorrhage With Intrathecal Injection of Nicardipine: a Multi-center, Prospective, Double-blinded, Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
396
Start Date
2024-05-27
Completion Date
2026-05
Last Updated
2025-09-08
Healthy Volunteers
No
Interventions
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First, 6 ml of cerebrospinal fluid is withdrawn from the EVD or LD catheter, and then 4 ml (4mg) of nicardipine is injected into the EVD or LD drain tube, followed by 2 ml normal saline solution, and then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.
Locations (28)
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