Actively Recruiting
Treatment of Vasospasm of Aneurysmal Subarachnoid Hemorrhage With Intrathecal Nicardipine - FAST-IT Trial
Led by The Affiliated Hospital Of Guizhou Medical University · Updated on 2025-09-08
396
Participants Needed
28
Research Sites
100 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Treatment of Vasospasm of Aneurysmal Subarachnoid Hemorrhage With Intrathecal Nicardipine - FAST-IT Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
Inclusion criteria:
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Age 18-80.
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Spontaneous SAH confirmed by head CT.
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Saccular brain aneurysm is identified and treated, either surgically or endovascularly.
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SAH Fisher grade >1 or modified Fisher grade >0.
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EVD placed for acute hydrocephalus, or LD placed for draining bloody CSF as deemed necessary by the treating physician.
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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.
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Within 14 days of onset of SAH.
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Informed consent obtained from the patient or family member.
Exclusion criteria:
- 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.
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
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Trial Site Locations
Total: 28 locations
1
Affiliated First Hospital of Anhui Medical University
Hefei, Anhui, China, 230000
Actively Recruiting
2
Beijing Tiantan Hospital, Affiliated to Capital Medical University
Beijing, Beijing Municipality, China, 100070
Actively Recruiting
3
Chongqing Ninth People's Hospital
Chongqing, Chongqing Municipality, China, 400799
Actively Recruiting
4
Southern Medical University Zhujiang Hospital
Guangzhou, Guangdong, China, 510260
Actively Recruiting
5
Affiliated South China Hospital of Shenzhen University
Shenzhen, Guangdong, China, 518111
Actively Recruiting
6
Nanning First People's Hospital
Nanning, Guangxi, China, 530016
Actively Recruiting
7
Jinyang Hospital Affiliated to Guizhou Medical University
Guiyang, Guizhou, China, 550080
Actively Recruiting
8
The Second Affiliated Hospital of Guizhou Medical University
Kaili, Guizhou, China, 556099
Actively Recruiting
9
Liupanshui City People's Hospital
Liupanshui, Guizhou, China, 553400
Actively Recruiting
10
People's Hospital of Qiannan Buyi and Miao Autonomous Prefecture, Guizhou Province
Xingyi, Guizhou, China, 558000
Actively Recruiting
11
Qianxinan Prefecture People's Hospital
Xingyi, Guizhou, China, 562499
Actively Recruiting
12
Xingyi City People's Hospital
Xingyi, Guizhou, China, 562499
Actively Recruiting
13
Qianfengdong Prefecture People's Hospital
Kaili, G, China, 556099
Actively Recruiting
14
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, China, 230601
Actively Recruiting
15
Nanyang Central Hospital, Henan Province
Nanyang, Henan, China, 473005
Actively Recruiting
16
Baotou Central Hospital
Baotou, Inner Mongolia, China, 014040
Actively Recruiting
17
Changzhou First People's Hospital
Changzhou, Jiangsu, China, 213004
Actively Recruiting
18
The First People's Hospital of Zhenjiang City, Jiangsu Province
Zhenjiang, Jiangsu, China, 212002
Actively Recruiting
19
Ganzhou People's Hospital
Ganzhou, Jiangxi, China, 341000
Actively Recruiting
20
Jinggangshan University Affiliated Hospital
Ji’an, Jiangxi, China, 343099
Actively Recruiting
21
Taian Central Hospital, Shandong Province
Tai’an, Shandong, China, 27109
Actively Recruiting
22
Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 201112
Actively Recruiting
23
The First Hospital of Shanxi Medical University
Taiyuan, Shanxi, China, 030001
Actively Recruiting
24
West China Airport Hospital of Sichuan University
Chengdu, Sichuan, China, 610299
Actively Recruiting
25
Western Medical University Affiliated Hospital
Luzhou, Sichuan, China, 646099
Actively Recruiting
26
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
27
Zhejiang Hospital
Hangzhou, Zhejiang, China, 310007
Actively Recruiting
28
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310009
Actively Recruiting
Research Team
G
Guangtang Chen, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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