New combo treatment aims to boost recovery after severe brain bleed
NCT ID NCT06284642
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether starting lumbar drainage and injecting the clot-busting drug urokinase early after a severe brain bleed improves patients' recovery. About 424 adults with a first-time severe aneurysmal subarachnoid hemorrhage will be randomly assigned to get either the active treatment or a placebo, on top of standard care. The main goal is to see if more people achieve a good functional outcome (able to live independently) at 6 months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- urokinase
- What this could lead to
- If it works, this could improve recovery and reduce disability after a severe brain bleed.
- What could go wrong
- This is a phase 4 trial, but the treatment is invasive and carries risks like infection or bleeding. It may not improve outcomes compared to standard care.
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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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 424 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2024
- Expected to finish
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Dec 2027
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 years and older
- 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: * Patient's age ≥ 18 years * First occurrence of aneurysmal subarachnoid hemorrhage * Patients without any craniotomy treatment before onset * Hunt-Hess grade III-V * mRS grade 0 or 1 before onset * Aneurysm treatment within 48 hours of onset * Informed consent given by the subject or guardian Exclusion Criteria: * Subarachnoid hemorrhage caused by arteriovenous malformation or moyamoya disease or other cerebrovascular disease * Patients requiring craniotomy to remove intracranial hematoma * modified Fisher Scale grade 0 * Prothrombin time (PT) and activated partial thromboplastin time (APTT) are greater than 2 times the extended range * Absolute contraindications for lumbar puncture (e.g., brain hernia, puncture site infection) * Patients with a life expectancy of less than 1 year due to other causes * Other concomitant serious diseases that are difficult to treat; * Pregnant woman * Patients who were known to be allergic to urokinase and excipients or had a history of severe allergy and were deemed unsuitable for inclusion by the investigators * Participated in another interventional clinical trial within 30 days before randomization * Other reasons deemed unsuitable for study participation by the investigator
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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
25 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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904th Hospital of Joint Logistic Support Force of PLA
RECRUITINGWuxi, Jiangsu, 214000, China
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Anhui Provincial Hospital
RECRUITINGHefei, Anhui, 230000, China
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Changhai Hospital, Naval Medical University
RECRUITINGShanghai, Shanghai Municipality, 200000, China
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First Affiliated Hospital of Gannan Medical University
RECRUITINGGanzhou, Jiangxi, 341000, China
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First Affiliated Hospital, Zhejiang University School of Medicine
RECRUITINGHangzhou, Zhejiang, 310000, China
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Ganzhou People's Hospital
RECRUITINGGanzhou, Jiangxi, 341000, China
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Henan Provincial People's Hospital
RECRUITINGZhengzhou, Henan, 450000, China
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Huashan hospital of fudan university
RECRUITINGShanghai, Shanghai Municipality, 200000, China
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Nanjing Drum Tower Hospital
RECRUITINGNanjing, Jiangsu, 210000, China
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Qilu hospital of shandong university
RECRUITINGJinan, Shandong, 250000, China
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Renmin Hospital of Wuhan University
RECRUITINGWuhan, Hubei, 430000, China
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Sichuan Provincial People's Hospital
RECRUITINGChengdu, Sichuan, 610000, China
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The First Affiliated Hospital of Anhui Medical University
RECRUITINGHeihe, Anhui, 230000, China
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The First Affiliated Hospital of Fujian Medical University
RECRUITINGFuzhou, Fujian, 350000, China
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The First Affiliated Hospital of Harbin Medical University
RECRUITINGHarbin, Heilongjiang, 150000, China
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The First Affiliated Hospital of Shandong First Medical University
RECRUITINGJinan, Shandong, 250000, China
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The First Affiliated Hospital of Zhengzhou University
RECRUITINGZhengzhou, Henan, 450000, China
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The Second Affiliated Hospital of Nanchang University
RECRUITINGNanchang, Jiangxi, 330006, China
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The Second Affiliated Hospital of Zhejiang University School of Medicine
RECRUITINGHangzhou, Zhejiang, 310000, China
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The first affiliated hospital of nanjing medical university
RECRUITINGNanjing, Jiangsu, 210000, China
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Tongji hospital, Tongji Medical College, Huazhong University of Science and Technology
RECRUITINGWuhan, Hubei, 430000, China
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Union hospital,Tongji Medical College, Huazhong University of Science and Technology
RECRUITINGWuhan, Hubei, 430000, China
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Xiangya Hospital of Central South University
RECRUITINGChangsha, Hunan, 410000, China
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Zhongnan Hospital of Wuhan University
RECRUITINGWuhan, Hubei, 430000, China
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Zhujiang Hospital of Southern Medical University
RECRUITINGGuangzhou, Guangdong, 510000, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- 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?