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RECRUITING
NCT06329635
NA

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

Sponsor: The Affiliated Hospital Of Guizhou Medical University

View on ClinicalTrials.gov

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

DRUG

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First, 6 ml of cerebrospinal fluid is withdrawn from the EVD or LD catheter, and then 4 ml (4mg) of nicardipine is injected into the EVD or LD drain tube, followed by 2 ml normal saline solution, and then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.

OTHER

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