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

NCT06329635 | Recruiting DMC

• 1 other identifier: 2023070K
• Study Type: interventional
• Target: 396
• Locations: 1 country
• Sites: 28

Brief 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.

Conditions

Aneurysmal Subarachnoid Hemorrhage; Vasospasm

Keywords

Aneurysmal Subarachnoid Hemorrhage; Vasospasm; Delayed cerebral ischemia; Nicardipine; Intrathecal injection

Outcome Measures

Primary Outcomes (1)

• Dichotomized Modified Rankin Scale (mRS) 0-2 vs 3-6

  The percentage of patients with mRS 0-2

  Day 90±30, Day 365±60.

Secondary Outcomes (11)

• Extended Glasgow Outcome Score (GOS-E).

  Day 90±30, Day 365±60.

• Modified Rankin Scale ordinal shift with mRS 5 and 6 combined

  Day 90±30, Day 365±60.

• Dichotomized Modified Rankin Scale (mRS) 0-3 vs 4-6

  Day 90±30, Day 365±60.

• Mini-Mental State Examination (MMSE) score

  Day 90±30, Day 365±60.

• Change of National Institutes of Health Stroke Scale (NIHSS) score

  At discharge

Study Arms (2)

Intrathecal Treatment Group

EXPERIMENTAL

The participants in the IT treatment group will be treated with intrathecal nicardipine injection through EVD or LP draining catheter.

Drug: Intrathecal Nicardipine

Control Group

SHAM COMPARATOR

The participants of the control group will receive no intrathecal nicardipine injection through EVD or LP draining catheter.

Other: No intervention

Interventions

Intrathecal Nicardipine DRUG

First, 6 ml of cerebrospinal fluid is withdrawn from the EVD or LD catheter, and then 4 ml (4mg) of nicardipine is injected into the EVD or LD drain tube, followed by 2 ml normal saline solution, and then the EVD or LD tube is clamped for 2 hours, and then kept open as clinically necessary until the next dose (q12h) of medication.

Also known as: Treatment group

Intrathecal Treatment Group

No intervention OTHER

A simulated "intrathecal administration" operation is performed by a dedicated physician who is unblinded to the group assignment, the EVD or LD tube is not opened, and no "drug" is given. The simulated administration process needs to be out of the patient's view (if awake patient) and out of the presence of study team personnel.

Also known as: Blank control group

Control Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• The Affiliated Hospital Of Guizhou Medical University: lead

Study Sites (28)

Affiliated First Hospital of Anhui Medical University

Hefei, Anhui, 230000, China

RECRUITING

Beijing Tiantan Hospital, Affiliated to Capital Medical University

Beijing, Beijing Municipality, 100070, China

RECRUITING

Chongqing Ninth People's Hospital

Chongqing, Chongqing Municipality, 400799, China

RECRUITING

Southern Medical University Zhujiang Hospital

Guangzhou, Guangdong, 510260, China

RECRUITING

Affiliated South China Hospital of Shenzhen University

Shenzhen, Guangdong, 518111, China

RECRUITING

Nanning First People's Hospital

Nanning, Guangxi, 530016, China

RECRUITING

Jinyang Hospital Affiliated to Guizhou Medical University

Guiyang, Guizhou, 550080, China

RECRUITING

The Second Affiliated Hospital of Guizhou Medical University

Kaili, Guizhou, 556099, China

RECRUITING

Liupanshui City People's Hospital

Liupanshui, Guizhou, 553400, China

RECRUITING

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

Xingyi, Guizhou, 558000, China

RECRUITING

Qianxinan Prefecture People's Hospital

Xingyi, Guizhou, 562499, China

RECRUITING

Xingyi City People's Hospital

Xingyi, Guizhou, 562499, China

RECRUITING

Qianfengdong Prefecture People's Hospital

Kaili, G, 556099, China

RECRUITING

The Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, 230601, China

RECRUITING

Nanyang Central Hospital, Henan Province

Nanyang, Henan, 473005, China

RECRUITING

Baotou Central Hospital

Baotou, Inner Mongolia, 014040, China

RECRUITING

Changzhou First People's Hospital

Changzhou, Jiangsu, 213004, China

RECRUITING

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

Zhenjiang, Jiangsu, 212002, China

RECRUITING

Ganzhou People's Hospital

Ganzhou, Jiangxi, 341000, China

RECRUITING

Jinggangshan University Affiliated Hospital

Ji’an, Jiangxi, 343099, China

RECRUITING

Taian Central Hospital, Shandong Province

Tai’an, Shandong, 27109, China

RECRUITING

Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 201112, China

RECRUITING

The First Hospital of Shanxi Medical University

Taiyuan, Shanxi, 030001, China

RECRUITING

West China Airport Hospital of Sichuan University

Chengdu, Sichuan, 610299, China

RECRUITING

Western Medical University Affiliated Hospital

Luzhou, Sichuan, 646099, China

RECRUITING

The First Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

RECRUITING

Zhejiang Hospital

Hangzhou, Zhejiang, 310007, China

RECRUITING

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

RECRUITING

Related Publications (39)

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MeSH Terms

Conditions

Subarachnoid Hemorrhage

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Zeguang Ren

  Affiliated Hospital of Guizhou Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guangtang Chen, MD

CONTACT

+8618286089635; 18286089635@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The assigned "intervention" will be performed only by a separate unblinded dedicated physician who signs the confidential agreement. The attending/investigating physician and patient are blinded to the intervention assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 19, 2024
• First Posted: March 26, 2024
• Study Start: May 27, 2024
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: September 8, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (28)