New minimally invasive procedure could change outcomes for bleeding stroke patients
NCT ID NCT07187687
First seen Jun 27, 2026 · Last updated Sep 10, 2026 · Updated 4 times
Summary
This study compares standard medical care to a new, less invasive surgery for people with a severe bleeding stroke. The surgery uses a small tube to drain the blood clot and delivers clot-busting medicine directly into the brain. Researchers want to see if this approach helps patients recover better and regain more function within 6 months. The trial is for adults with a large brain bleed who can be treated within 8 hours of symptoms starting.
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 750 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2025
- Expected to finish
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Mar 2028
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: 1. Age ≥ 18 years; 2. Pre-randomization head CT demonstrating an acute, spontaneous, primary ICH; 3. ICH volume ≥ 20mL as calculated by the ABC/2 method; 4. The randomization can be completed within 8 hours after the onset of stroke symptoms (or the time last known to be well), and study intervention can reasonably be initiated within 4 hours after randomization. 5. Historical Modified Rankin Score 0 or 1; 6. Obtain informed consent from patient or legal representative. Exclusion Criteria: 1. Infratentorial intraparenchymal hemorrhage including midbrain, pontine, or cerebellar; 2. Ruptured aneurysm, arteriovenous malformation (AVM), vascular anomaly, Moyamoya disease, venous sinus thrombosis, mass or tumor, hemorrhagic conversion of an ischemic infarct, tumor stroke, recurrence of a recent (\<1 year) ICH, as diagnosed with radiographic imaging; 3. Presence of spot sign in CT angiography; 4. Blood pressure control before randomization is ineffective, systolic blood pressure \> 220 mmHg; 5. Irreversible impaired brain stem function (bilateral fixed, dilated pupils and extensor motor posturing), GCS ≤ 4; 6. Hemorrhage with apparent midbrain extension with third nerve palsy or dilated and non-reactive pupils. Other (supranuclear) gaze abnormalities are not exclusions; 7. Intraventricular extension of the Hemorrhage is visually estimated to involve \>50% of either of the lateral ventricles; 8. Any irreversible coagulopathy or known clotting disorder. 9. Platelet count \< 750,000, INR \> 1.4 after correction 10. Patients requiring long-term anti-coagulation that needs to be initiated \< 30 days from index ICH; 11. Use of 2 or more antithrombotic drugs prior to symptom onset; 12. Patients with a mechanical heart valve; 13. Positive urine or serum pregnancy test in female subjects without documented history of surgical sterilization or is post-menopausal; 14. Urokinase allergy; 15. Any concurrent serious illness that would interfere with the outcome assessments including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, immunologic, and hematologic disease; 16. Inability or unwillingness of patient or legal representative to give written informed consent; 17. Known life-expectancy of less than 6 months; 18. Participation in a concurrent interventional medical investigation or clinical trial.
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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
69 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 Hospital of Hebei University of Engineering
NOT_YET_RECRUITINGHebei, China
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Affiliated Hospital of Inner Mongolia Medical University
RECRUITINGHohhot, China
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Affiliated Hospital of Nantong University
RECRUITINGNantong, China
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Baotou Central Hospital
RECRUITINGBaotou, China
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Beijing Chao-Yang Hospital, Capital Medical University
RECRUITINGBeijing, China
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Beijing Daxing District People's Hospital
RECRUITINGBeijing, China
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Beijing Fengtai You'anmen Hospital
RECRUITINGBeijing, China
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Beijing Friendship Hospital, Capital Medical University
RECRUITINGBeijing, China
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Bozhou city people's hospital
RECRUITINGBozhou, China
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Center Hospital of Nanyang
RECRUITINGNanyang, China
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Central People's Hospital of Siping City
RECRUITINGSiping, China
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Changsha Central Hospital
RECRUITINGChangsha, China
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Changzhi Medical College Affiliated Heji Hospital
RECRUITINGChangzhi, China
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Chifeng Municipal Hospital
RECRUITINGChifeng, China
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Chongqing Emergency Medical Service
RECRUITINGChongqing, China
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Chongqing Red Cross Hospital
NOT_YET_RECRUITINGChongqing, China
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First Affiliated Hospital of Dalian Medical University
RECRUITINGDalian, China
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First Affiliated Hospital of Gannan Medical University
RECRUITINGGannan, China
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First Affiliated Hospital of Xinjiang Medical University
RECRUITINGÜrümqi, China
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First Hospital of Shanxi Medical University
RECRUITINGShanxi, China
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Fujian Zhangzhou Municipal Hospital
RECRUITINGFujian, China
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Fuxin Second People\'s Hospital
NOT_YET_RECRUITINGFuxin, China
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Fuyang People's Hospital
RECRUITINGFuyang, China
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Guangdong Provincial People's Hospital
RECRUITINGGuangdong, Yuexiu, China
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Guiyang Second People's Hospital
NOT_YET_RECRUITINGGuiyang, China
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Handan Central Hospital
RECRUITINGHandan, China
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Henan Provincial People's Hospital
RECRUITINGZhengzhou, China
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Huizhou First People's Hospital
NOT_YET_RECRUITINGHuizhou, China
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Jinan City People's Hospital
RECRUITINGJinan, China
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Jinan Hospital of Xuanwu Hospital, Capital Medical University
RECRUITINGJinan, China
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Liaocheng Brain Hospital
NOT_YET_RECRUITINGLiaocheng, China
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Peking University Aerospace Central Hospital
NOT_YET_RECRUITINGBeijing, China
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People's Hospital of Chongqing Banan District
RECRUITINGChongqing, China
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Quzhou People's Hospital
RECRUITINGQuzhou, China
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Shanghai Fourth People's Hospital Affiliated to Tongji University
RECRUITINGShanghai, China
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Shanghai Sixth People's Hospital Affiliated to Shanghai JiaoTong University
RECRUITINGShanghai, China
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Shanghai Tenth People's Hospital
RECRUITINGShanghai, China
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Shunyi District Hospital in Beijing
RECRUITINGBeijing, China
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Suining Central Hospital
RECRUITINGSichuan, China
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Taihe Hospital in Shiyan City
RECRUITINGShiyan, China
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Tangshan Workers' Hospita
RECRUITINGTangshan, China
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The First Affiliated Hospital of Anhui Medical University
RECRUITINGHefei, China
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The First Affiliated Hospital of China Medical University
RECRUITINGShenyang, China
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The First Affiliated Hospital of Nanchang University
RECRUITINGNanchang, China
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The First Affiliated Hospital of Ningbo University
RECRUITINGNingbo, China
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The First Affiliated Hospital of Wenzhou Medical University
RECRUITINGWenzhou, China
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The First Affiliated Hospital of Xiamen University
RECRUITINGXiamen, China
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The First Hospital of China Medical University
RECRUITINGShenyang, China
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The First Hospital of Harbin Medical University
NOT_YET_RECRUITINGHarbin, China
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The First Hospital of Hebei Medical University
RECRUITINGShijiazhuang, China
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The First People Hospital of Yunnan Province
RECRUITINGKunming, China
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The First People's Hospital of Changzhou
RECRUITINGChangzhou, China
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The First People's Hospital of Nanning
NOT_YET_RECRUITINGNanning, China
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The Fourth People's Hospital of Zigong City
RECRUITINGZigong, China
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The Second Affiliated Hospital of Shandong First Medical University
RECRUITINGTai’an, China
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The Second Affiliated Hospital of Wenzhou Medical University
NOT_YET_RECRUITINGWenzhou, China
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The Second Affiliated Hospital of Zhengzhou University
RECRUITINGZhengzhou, China
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The Seventh Affiliated Hospital of Southern Medical University
NOT_YET_RECRUITINGGuangdong, China
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Third People's Hospital of Hainan Province
RECRUITINGSanya, China
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Tianjin Huanhu Hospital
RECRUITINGTianjin, China
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Tibet People's Hospital
RECRUITINGLasa, China
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University of Chinese Academy of Sciences Ningbo Huamei Hospital
RECRUITINGNingbo, China
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Weifang People's Hospital
RECRUITINGWeifang, China
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Xiangyang Central Hospital
RECRUITINGXiangyang, China
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Xingan League People's Hospita
RECRUITINGNeimeng, China
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Xuanwu Hospital, Capital Medical University
RECRUITINGBeijing, China
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Yanan Medical College of Yanan University
RECRUITINGYan’an, China
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Yichang Central People's Hospital
NOT_YET_RECRUITINGYichang, China
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Zhangjiajie City People's Hospital
RECRUITINGZhangjiajie, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a web program rebuild memory after brain injury?
- Portable MRI could speed up stroke treatment
- Can a herbal formula match traditional medicine for brain bleeds?
- Can a blood marker tell fever from infection in stroke?
- Can blood markers predict brain injury outcomes?
- Can an ancient herbal pill improve outcomes after a bleeding stroke?