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

Recruiting now · Not applicable

Conditions studied: Aneurysmal Subarachnoid Hemorrhage, Vasospasm

In brief

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.

Key facts

Study ID

NCT06329635

Run by

The Affiliated Hospital Of Guizhou Medical University

People needed

396

Starts

2024-05-27

Expected to finish

2026-05-01

Last updated by the study team

2025-09-08

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18-80.
• Spontaneous SAH confirmed by head CT.
• Saccular brain aneurysm is identified and treated, either surgically or endovascularly.
• SAH Fisher grade >1 or modified Fisher grade >0.
• EVD placed for acute hydrocephalus, or LD placed for draining bloody CSF as deemed necessary by the treating physician.
• Any clinical scenario leading to the diagnosis of possible vasospasm, which includes:
• Mean flow velocity of MCA >120, or Lindegaard Ratio ( LR ) > 3.
• 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).
• Clinical deterioration including mental status change (GCS score decrease > 2) and focal neurological deficit unable to be attributed to other known neurological reasons.
• Evidence of vasospasm on CTA or DSA, or ischemic change by CTP, MRI.
• Within 14 days of onset of SAH.
• Informed consent obtained from the patient or family member.

You may not qualify if…

• Hunt-Hess Grade 5 or WFNS Grade 5 (no clinical improvement after EVD placement for acute hydrocephalus).
• Bacterial or distal aneurysms without subarachnoid hemorrhage in the basal cisterns.
• The treating physician determines that the culprit aneurysm has not been fully repaired, with a very high likelihood of rebleeding in the near term.
• History of head trauma within the past 3 months.
• Any recent brain disease within 3 months, such as tumors, stroke, epilepsy, vasculitis, arteriovenous malformation, hydrocephalus, etc.
• History of psychiatric disorders or seizures within 3 months.
• Severe concurrent medical conditions.
• Pregnant women or those of childbearing potential with a positive urine or serum β-human chorionic gonadotropin (HCG) test.
• Lactating women.
• Life expectancy of less than 1 year prior to aSAH onset.
• Pre-morbid mRS score >1.
• Participation in another randomized clinical trial that may confound the evaluation of this study.

Where it is running

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

Full record on ClinicalTrials.gov

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