Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
NCT06329635

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

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

Inclusion criteria:

  1. Age 18-80.

  2. Spontaneous SAH confirmed by head CT.

  3. Saccular brain aneurysm is identified and treated, either surgically or endovascularly.

  4. SAH Fisher grade >1 or modified Fisher grade >0.

  5. EVD placed for acute hydrocephalus, or LD placed for draining bloody CSF as deemed necessary by the treating physician.

  6. Any clinical scenario leading to the diagnosis of possible vasospasm, which includes:

    1. Mean flow velocity of MCA >120, or Lindegaard Ratio ( LR ) > 3.
    2. 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).
    3. Clinical deterioration including mental status change (GCS score decrease > 2) and focal neurological deficit unable to be attributed to other known neurological reasons.
    4. Evidence of vasospasm on CTA or DSA, or ischemic change by CTP, MRI.
  7. Within 14 days of onset of SAH.

  8. Informed consent obtained from the patient or family member.

Exclusion criteria:

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

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

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