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Clinical Trials in China / NCT07187687
Recruiting Not applicable

TrIal of Early Minimally Invasive Catheter Evacuation With Thrombolysis in IntraCerebral Hemorrhage

NCT07187687 · tracked via the Priya Life Science China tracker
Sponsor
Xuanwu Hospital, Beijing
Phase
Not applicable
Started
2025-10-24
Last updated
2026-09-09

Condition(s) studied

Intracerebral Hemorrhage

Investigational drug(s) / intervention(s)

Early Minimally Invasive Surgery with Thrombolysis (eMIST)

Early Minimally Invasive Surgery with Thrombolysis (eMIST): Subjects will undergo minimally invasive catheter evacuation in the early stage of intracranial hemorrhage. Up to 10 doses of 50000U of urokinase will be administered through the catheter that was placed directly into the intracerebral hemorrhage.

Study summary

TIME-ICH (TrIal of early Minimally Invasive catheter Evacuation with thrombolysis in IntraCerebral Hemorrhage) is a multicenter, randomized, adaptive clinical trial comparing best medical management to early minimally invasive surgery with thrombolysis (eMIST) in the treatment of acute spontaneous supratentorial intracerebral hemorrhage.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (69)

FacilityCityRegionStatus
Guangdong Provincial People's Hospital Guangdong Yuexiu Recruiting
Baotou Central Hospital Baotou China Recruiting
Beijing Chao-Yang Hospital, Capital Medical University Beijing China Recruiting
Beijing Daxing District People's Hospital Beijing China Recruiting
Beijing Fengtai You'anmen Hospital Beijing China Recruiting
Beijing Friendship Hospital, Capital Medical University Beijing China Recruiting
Peking University Aerospace Central Hospital Beijing China Not Yet Recruiting
Shunyi District Hospital in Beijing Beijing China Recruiting
Xuanwu Hospital, Capital Medical University Beijing China Recruiting
Bozhou city people's hospital Bozhou China Recruiting
Changsha Central Hospital Changsha China Recruiting
Changzhi Medical College Affiliated Heji Hospital Changzhi China Recruiting
The First People's Hospital of Changzhou Changzhou China Recruiting
Chifeng Municipal Hospital Chifeng China Recruiting
Chongqing Emergency Medical Service Chongqing China Recruiting
Chongqing Red Cross Hospital Chongqing China Not Yet Recruiting
People's Hospital of Chongqing Banan District Chongqing China Recruiting
First Affiliated Hospital of Dalian Medical University Dalian China Recruiting
Fujian Zhangzhou Municipal Hospital Fujian China Recruiting
Fuxin Second People\'s Hospital Fuxin China Not Yet Recruiting
Fuyang People's Hospital Fuyang China Recruiting
First Affiliated Hospital of Gannan Medical University Gannan China Recruiting
The Seventh Affiliated Hospital of Southern Medical University Guangdong China Not Yet Recruiting
Guiyang Second People's Hospital Guiyang China Not Yet Recruiting
Handan Central Hospital Handan China Recruiting
The First Hospital of Harbin Medical University Harbin China Not Yet Recruiting
Affiliated Hospital of Hebei University of Engineering Hebei China Not Yet Recruiting
The First Affiliated Hospital of Anhui Medical University Hefei China Recruiting
Affiliated Hospital of Inner Mongolia Medical University Hohhot China Recruiting
Huizhou First People's Hospital Huizhou China Not Yet Recruiting
Jinan City People's Hospital Jinan China Recruiting
Jinan Hospital of Xuanwu Hospital, Capital Medical University Jinan China Recruiting
The First People Hospital of Yunnan Province Kunming China Recruiting
Tibet People's Hospital Lasa China Recruiting
Liaocheng Brain Hospital Liaocheng China Not Yet Recruiting
The First Affiliated Hospital of Nanchang University Nanchang China Recruiting
The First People's Hospital of Nanning Nanning China Not Yet Recruiting
Affiliated Hospital of Nantong University Nantong China Recruiting
Center Hospital of Nanyang Nanyang China Recruiting
Xingan League People's Hospita Neimeng China Recruiting

+ 29 more sites — see the full list on the official registry below.

More Xuanwu Hospital, Beijing trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07187687 on ClinicalTrials.gov ↗ ← All trials in China