Spinal injection may prevent brain damage after aneurysm
NCT ID NCT06329635
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
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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
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About 396 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2024
- Expected to finish
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May 2026
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
28 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Affiliated First Hospital of Anhui Medical University
RECRUITINGHefei, Anhui, 230000, China
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Affiliated South China Hospital of Shenzhen University
RECRUITINGShenzhen, Guangdong, 518111, China
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Baotou Central Hospital
RECRUITINGBaotou, Inner Mongolia, 014040, China
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Beijing Tiantan Hospital, Affiliated to Capital Medical University
RECRUITINGBeijing, Beijing Municipality, 100070, China
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Changzhou First People's Hospital
RECRUITINGChangzhou, Jiangsu, 213004, China
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Chongqing Ninth People's Hospital
RECRUITINGChongqing, Chongqing Municipality, 400799, China
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Ganzhou People's Hospital
RECRUITINGGanzhou, Jiangxi, 341000, China
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Jinggangshan University Affiliated Hospital
RECRUITINGJi’an, Jiangxi, 343099, China
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Jinyang Hospital Affiliated to Guizhou Medical University
RECRUITINGGuiyang, Guizhou, 550080, China
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Liupanshui City People's Hospital
RECRUITINGLiupanshui, Guizhou, 553400, China
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Nanning First People's Hospital
RECRUITINGNanning, Guangxi, 530016, China
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Nanyang Central Hospital, Henan Province
RECRUITINGNanyang, Henan, 473005, China
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People's Hospital of Qiannan Buyi and Miao Autonomous Prefecture, Guizhou Province
RECRUITINGXingyi, Guizhou, 558000, China
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Qianfengdong Prefecture People's Hospital
RECRUITINGKaili, G, 556099, China
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Qianxinan Prefecture People's Hospital
RECRUITINGXingyi, Guizhou, 562499, China
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Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
RECRUITINGShanghai, Shanghai Municipality, 201112, China
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Southern Medical University Zhujiang Hospital
RECRUITINGGuangzhou, Guangdong, 510260, China
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Taian Central Hospital, Shandong Province
RECRUITINGTai’an, Shandong, 27109, China
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The First Affiliated Hospital of Zhejiang University School of Medicine
RECRUITINGHangzhou, Zhejiang, 310000, China
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The First Hospital of Shanxi Medical University
RECRUITINGTaiyuan, Shanxi, 030001, China
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The First People's Hospital of Zhenjiang City, Jiangsu Province
RECRUITINGZhenjiang, Jiangsu, 212002, China
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The Second Affiliated Hospital of Guizhou Medical University
RECRUITINGKaili, Guizhou, 556099, China
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The Second Affiliated Hospital of Zhejiang University School of Medicine
RECRUITINGHangzhou, Zhejiang, 310009, China
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The Second Hospital of Hebei Medical University
RECRUITINGShijiazhuang, Hebei, 230601, China
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West China Airport Hospital of Sichuan University
RECRUITINGChengdu, Sichuan, 610299, China
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Western Medical University Affiliated Hospital
RECRUITINGLuzhou, Sichuan, 646099, China
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Xingyi City People's Hospital
RECRUITINGXingyi, Guizhou, 562499, China
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Zhejiang Hospital
RECRUITINGHangzhou, Zhejiang, 310007, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Two salts, one goal: which brain swelling treatment works best?
- Can a Nerve-Blocking drug stop the worst headaches after a brain bleed?
- Blood clot markers may forecast stroke outcomes
- Can a Brain-Bleed drug protect memory after surgery?
- Can a blood pressure cuff shield the brain after a severe stroke?
- Can a gentle ear zap calm the Brain's overactive 'Fight or Flight' response?