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Spinal injection may prevent brain damage after aneurysm

NCT ID NCT06329635

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tests whether injecting the drug nicardipine into the spinal fluid can improve recovery in people who develop blood vessel spasms after a brain aneurysm bleed. About 396 adults aged 18–80 will receive either the drug or a sham procedure. The goal is to see if the treatment reduces long-term disability.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
nicardipine
What this could lead to
If it works, this could provide a new way to treat dangerous blood vessel spasms after a brain aneurysm bleed, potentially reducing disability.
What could go wrong
This is a mid-stage trial with 396 participants, so results are not yet proven. The treatment involves a spinal injection, which carries risks like infection or bleeding.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 396 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2024

Expected to finish

May 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    28 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Affiliated First Hospital of Anhui Medical University

    RECRUITING

    Hefei, Anhui, 230000, China

  • Affiliated South China Hospital of Shenzhen University

    RECRUITING

    Shenzhen, Guangdong, 518111, China

  • Baotou Central Hospital

    RECRUITING

    Baotou, Inner Mongolia, 014040, China

  • Beijing Tiantan Hospital, Affiliated to Capital Medical University

    RECRUITING

    Beijing, Beijing Municipality, 100070, China

  • Changzhou First People's Hospital

    RECRUITING

    Changzhou, Jiangsu, 213004, China

  • Chongqing Ninth People's Hospital

    RECRUITING

    Chongqing, Chongqing Municipality, 400799, China

  • Ganzhou People's Hospital

    RECRUITING

    Ganzhou, Jiangxi, 341000, China

  • Jinggangshan University Affiliated Hospital

    RECRUITING

    Ji’an, Jiangxi, 343099, China

  • Jinyang Hospital Affiliated to Guizhou Medical University

    RECRUITING

    Guiyang, Guizhou, 550080, China

  • Liupanshui City People's Hospital

    RECRUITING

    Liupanshui, Guizhou, 553400, China

  • Nanning First People's Hospital

    RECRUITING

    Nanning, Guangxi, 530016, China

  • Nanyang Central Hospital, Henan Province

    RECRUITING

    Nanyang, Henan, 473005, China

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

    RECRUITING

    Xingyi, Guizhou, 558000, China

  • Qianfengdong Prefecture People's Hospital

    RECRUITING

    Kaili, G, 556099, China

  • Qianxinan Prefecture People's Hospital

    RECRUITING

    Xingyi, Guizhou, 562499, China

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

    RECRUITING

    Shanghai, Shanghai Municipality, 201112, China

  • Southern Medical University Zhujiang Hospital

    RECRUITING

    Guangzhou, Guangdong, 510260, China

  • Taian Central Hospital, Shandong Province

    RECRUITING

    Tai’an, Shandong, 27109, China

  • The First Affiliated Hospital of Zhejiang University School of Medicine

    RECRUITING

    Hangzhou, Zhejiang, 310000, China

  • The First Hospital of Shanxi Medical University

    RECRUITING

    Taiyuan, Shanxi, 030001, China

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

    RECRUITING

    Zhenjiang, Jiangsu, 212002, China

  • The Second Affiliated Hospital of Guizhou Medical University

    RECRUITING

    Kaili, Guizhou, 556099, China

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    RECRUITING

    Hangzhou, Zhejiang, 310009, China

  • The Second Hospital of Hebei Medical University

    RECRUITING

    Shijiazhuang, Hebei, 230601, China

  • West China Airport Hospital of Sichuan University

    RECRUITING

    Chengdu, Sichuan, 610299, China

  • Western Medical University Affiliated Hospital

    RECRUITING

    Luzhou, Sichuan, 646099, China

  • Xingyi City People's Hospital

    RECRUITING

    Xingyi, Guizhou, 562499, China

  • Zhejiang Hospital

    RECRUITING

    Hangzhou, Zhejiang, 310007, China

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