Impact of medical complications on outcome after subarachnoid hemorrhage.
Katja E Wartenberg, J Michael Schmidt, Jan Claassen...
https://pubmed.ncbi.nlm.nih.gov/16521258Actively Recruiting
Phase Not Applicable
Age: 18Years - 80Years
All Genders
ID06329635
Trial of Treatment of Vasospasm Associated With Aneurysmal Subarachnoid Hemorrhage With Intrathecal Injection of Nicardipine: a Multi-center, Prospective, Double-blinded, Randomized Controlled Trial
Led by The Affiliated Hospital Of Guizhou Medical University · Updated on 2025-09-08
396
Participants Needed
28
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether injecting nicardipine directly into the cerebrospinal fluid improves outcomes for patients with cerebral vasospasm caused by aneurysmal subarachnoid hemorrhage. This multi-center, prospective, double-blinded, randomized controlled trial compares two methods of delivering nicardipine: through extraventricular drainage (EVD) or lumbar drainage (LD). The study aims to determine which approach leads to a better prognosis for affected patients. Participants in the treatment group receive intrathecal nicardipine injections via EVD or LD catheters. The process involves withdrawing 6 ml of cerebrospinal fluid, injecting 4 ml (4 mg) of nicardipine hydrochloride, followed by 2 ml of saline, then clamping the catheter for 2 hours. This dosing is done twice daily. The control group undergoes a simulated procedure without receiving the drug. The drainage tubes remain open as clinically needed between doses. During the study, participants are monitored for outcomes using multiple scales, including the Modified Rankin Scale at 90 and 365 days, Glasgow Outcome Score, MMSE, NIH Stroke Scale, and rates of complications like infections or hemorrhage. Safety is assessed through adverse event tracking. Follow-up visits occur up to one year after treatment. The entire study period spans from the start of treatment to long-term outcome evaluations.
CONDITIONS
Brief Title
Treatment of Vasospasm of Aneurysmal Subarachnoid Hemorrhage With Intrathecal Nicardipine - FAST-IT Trial
Who Can Participate
Age: 18Years - 80Years
All Genders
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years
- Spontaneous subarachnoid hemorrhage confirmed by head CT
- Identified and treated saccular brain aneurysm, either surgically or endovascularly
- SAH Fisher grade greater than 1 or modified Fisher grade greater than 0
- Extraventricular drainage (EVD) or lumbar drainage (LD) catheter placed as needed
- Clinical signs or imaging evidence of possible vasospasm
- Mean flow velocity of middle cerebral artery (MCA) over 120 or Lindegaard Ratio over 3
- Upward trend of mean flow velocity in intracranial arteries for 2 consecutive days
- Clinical deterioration including mental status change or neurological deficit
- Evidence of vasospasm on CTA, DSA, CTP, or MRI
- Within 14 days of subarachnoid hemorrhage onset
- Informed consent obtained from patient or family member
You will not qualify if you...
- Hunt-Hess Grade 5 or WFNS Grade 5 with no improvement after EVD placement
- Bacterial or distal aneurysms without basal cistern subarachnoid hemorrhage
- Culprit aneurysm not fully repaired with high risk of rebleeding
- History of head trauma within past 3 months
- Recent brain diseases within 3 months (tumors, stroke, epilepsy, vasculitis, AV malformation, hydrocephalus)
- History of psychiatric disorders or seizures within 3 months
- Severe concurrent medical conditions
- Pregnant women or women of childbearing potential with positive pregnancy test
- Lactating women
- Life expectancy less than 1 year prior to aSAH onset
- Pre-morbid Modified Rankin Scale score greater than 1
- Participation in other randomized clinical trials that may interfere with this study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - Up to 21 days
Participants receive intrathecal nicardipine injections or a simulated procedure twice daily through an extraventricular or lumbar drainage catheter to treat cerebral vasospasm.
Twice daily administration visits
Follow-up
Duration - Up to 12 months
Participants are monitored for safety and recovery, including assessment of neurological outcomes and adverse events.
Visits at approximately 90 days and 365 days after treatment start
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
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Research Team
G
Guangtang Chen, MD
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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Published Research Related To This Trial
Cognitive and functional outcome after aneurysmal subarachnoid hemorrhage.
Timour Al-Khindi, R Loch Macdonald, Tom A Schweizer
https://pubmed.ncbi.nlm.nih.gov/20595669Vasospasm versus delayed cerebral ischemia as an outcome event in clinical trials and observational studies.
Mervyn D I Vergouwen, Participants in the International Multi-Disciplinary Consensus Conference on the Critical Care Management of Subarachnoid Hemorrhage
https://pubmed.ncbi.nlm.nih.gov/21748502Quality of life and healthcare resource use associated with angiographic vasospasm after aneurysmal subarachnoid hemorrhage.
R Loch Macdonald, Elke Hunsche, René Schüler...
https://pubmed.ncbi.nlm.nih.gov/22328549Predictors of global cognitive impairment 1 year after subarachnoid hemorrhage.
Mellanie V Springer, J Michael Schmidt, Katja E Wartenberg...
https://pubmed.ncbi.nlm.nih.gov/19934963Predictors of excellent functional outcome in aneurysmal subarachnoid hemorrhage.
Marianna Pegoli, Jay Mandrekar, Alejandro A Rabinstein...
https://pubmed.ncbi.nlm.nih.gov/25495745Defining vasospasm after subarachnoid hemorrhage: what is the most clinically relevant definition?
Jennifer A Frontera, Andres Fernandez, J Michael Schmidt...
https://pubmed.ncbi.nlm.nih.gov/19359629Definition of delayed cerebral ischemia after aneurysmal subarachnoid hemorrhage as an outcome event in clinical trials and observational studies: proposal of a multidisciplinary research group.
Mervyn D I Vergouwen, Marinus Vermeulen, Jan van Gijn...
https://pubmed.ncbi.nlm.nih.gov/20798370Update on intrathecal management of cerebral vasospasm: a systematic review and meta-analysis.
Audrey A Grossen, Griffin L Ernst, Andrew M Bauer
https://pubmed.ncbi.nlm.nih.gov/35231885Relation of cerebral vasospasm to subarachnoid hemorrhage visualized by computerized tomographic scanning.
C M Fisher, J P Kistler, J M Davis
https://pubmed.ncbi.nlm.nih.gov/7354892