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

Last updated: September 2, 2025
Sponsor: The Affiliated Hospital Of Guizhou Medical University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hemorrhage

Stroke

Treatment

Intrathecal Nicardipine

No intervention

Clinical Study ID

NCT06329635
2023070K
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion criteria:

  1. Age 18-80.

  2. Spontaneous SAH confirmed by head CT.

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

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

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

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

  7. Mean flow velocity of MCA >120, or Lindegaard Ratio ( LR ) > 3.

  8. Any intracranial artery including MCA, ACA, PCA, and BA, TCD showed an upwardtrend of mean flow velocity for 2 consecutive days (>25cm/s/day).

  9. Clinical deterioration including mental status change (GCS score decrease > 2)and focal neurological deficit unable to be attributed to other knownneurological reasons.

  10. Evidence of vasospasm on CTA or DSA, or ischemic change by CTP, MRI.

  11. Within 14 days of onset of SAH.

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

Exclusion

Exclusion criteria:

  1. Hunt-Hess Grade 5 or WFNS Grade 5 (no clinical improvement after EVD placement foracute 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 fullyrepaired, 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 evaluationof this study.

Study Design

Total Participants: 396
Treatment Group(s): 2
Primary Treatment: Intrathecal Nicardipine
Phase:
Study Start date:
May 27, 2024
Estimated Completion Date:
May 31, 2026

Study Description

Objective:

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.

Design:

This study is a multi-center, prospective, double-blinded, randomized controlled trial.

Interventions:

First, 6 ml of cerebrospinal fluid is withdrawn from the EVD or LD catheter, and then 4 ml of nicardipine hydrochloride is injected into the EVD or LD drain tube, followed by 2 ml of 0.9 % sodium chloride solution (NaCl), and then the EVD or LD tube was clamped for 2 hours after the injection was completed, then kept open as clinically necessary until the next dose (twice a day).

Connect with a study center

  • Affiliated First Hospital of Anhui Medical University

    Hefei 1808722, Anhui 1818058 230000
    China

    Active - Recruiting

  • Beijing Tiantan Hospital, Affiliated to Capital Medical University

    Beijing 1816670, Beijing Municipality 2038349 100070
    China

    Active - Recruiting

  • Chongqing Ninth People's Hospital

    Chongqing 1814906, Chongqing Municipality 1814905 400799
    China

    Active - Recruiting

  • Qianfengdong Prefecture People's Hospital

    Kaili 1804866, G 556099
    China

    Active - Recruiting

  • Southern Medical University Zhujiang Hospital

    Guangzhou 1809858, Guangdong 1809935 510260
    China

    Active - Recruiting

  • Affiliated South China Hospital of Shenzhen University

    Shenzhen 1795565, Guangdong 1809935 518111
    China

    Active - Recruiting

  • Nanning First People's Hospital

    Nanning 1799869, Guangxi 1809867 530016
    China

    Active - Recruiting

  • Jinyang Hospital Affiliated to Guizhou Medical University

    Guiyang 1809461, Guizhou 1809445 550080
    China

    Active - Recruiting

  • The Second Affiliated Hospital of Guizhou Medical University

    Kaili 1804866, Guizhou 1809445 556099
    China

    Active - Recruiting

  • Liupanshui City People's Hospital

    Liupanshui 8533133, Guizhou 1809445 553400
    China

    Active - Recruiting

  • People's Hospital of Qiannan Buyi and Miao Autonomous Prefecture, Guizhou Province

    Xingyi 1807566, Guizhou 1809445 558000
    China

    Active - Recruiting

  • Qianxinan Prefecture People's Hospital

    Xingyi 1807566, Guizhou 1809445 562499
    China

    Active - Recruiting

  • Xingyi City People's Hospital

    Xingyi 1807566, Guizhou 1809445 562499
    China

    Active - Recruiting

  • The Second Hospital of Hebei Medical University

    Shijiazhuang 1795270, Hebei 1808773 230601
    China

    Active - Recruiting

  • Nanyang Central Hospital, Henan Province

    Nanyang 1799629, Henan 1808520 473005
    China

    Active - Recruiting

  • Baotou Central Hospital

    Baotou 2038432, Inner Mongolia 2035607 014040
    China

    Active - Recruiting

  • Baotou Central Hospital

    Baotou, Inner Mongolia Autonomous Region 014040
    China

    Site Not Available

  • Changzhou First People's Hospital

    Changzhou 1815456, Jiangsu 1806260 213004
    China

    Active - Recruiting

  • The First People's Hospital of Zhenjiang City, Jiangsu Province

    Zhenjiang 1784642, Jiangsu 1806260 212002
    China

    Active - Recruiting

  • Ganzhou People's Hospital

    Ganzhou 1810638, Jiangxi 1806222 341000
    China

    Active - Recruiting

  • Jinggangshan University Affiliated Hospital

    Ji’an 1806445, Jiangxi 1806222 343099
    China

    Active - Recruiting

  • Taian Central Hospital, Shandong Province

    Tai’an 1793724, Shandong 1796328 27109
    China

    Active - Recruiting

  • Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

    Shanghai 1796236, Shanghai Municipality 1796231 201112
    China

    Active - Recruiting

  • The First Hospital of Shanxi Medical University

    Taiyuan 1793511, Shanxi 1795912 030001
    China

    Active - Recruiting

  • West China Airport Hospital of Sichuan University

    Chengdu 1815286, Sichuan 1794299 610299
    China

    Active - Recruiting

  • Western Medical University Affiliated Hospital

    Luzhou 1801640, Sichuan 1794299 646099
    China

    Active - Recruiting

  • The First Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou 1808926, Zhejiang 1784764 310000
    China

    Active - Recruiting

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou 1808926, Zhejiang 1784764 310009
    China

    Active - Recruiting

  • Zhejiang Hospital

    Hangzhou 1808926, Zhejiang 1784764 310007
    China

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.