TrIal of Early Minimally Invasive Catheter Evacuation With Thrombolysis in IntraCerebral Hemorrhage
TIME-ICH
1 other identifier
interventional
750
1 country
50
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2025
Typical duration for not_applicable
50 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 10, 2025
CompletedFirst Posted
Study publicly available on registry
September 23, 2025
CompletedStudy Start
First participant enrolled
October 24, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2028
March 9, 2026
November 1, 2025
1.9 years
September 10, 2025
March 6, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Functional Improvement - uw-mRS
Functional Improvement as determined by utility-weighted modified Rankin Scale (uw-mRS) which is assigned to seven levels: 1.0, 0.91, 0.76, 0.65, 0.33, 0.0, and 0.0 (with higher scores indicating a better outcome, according to patients' assessment) at 180-days.
180 days
Secondary Outcomes (6)
Functional Improvement - uw-mRS
7 days, 14 days (discharge), 30 days and 90 days
Functional Improvement - good functional outcome
7 days, 14 days (discharge), 30 days, 90 days and 180 days
Mortality
180 days
Clot Removal - Amount of Residual Blood
36 hours, 7 days and 14 days (discharge)
Health-related quality of life - EQ-5D-5L
14 days (discharge), 30 days, 90 days and 180 days
- +1 more secondary outcomes
Other Outcomes (5)
Safety - All Cause Mortality
30 days
Safety - Procedure-Related Mortality
7 days
Safety - Bacterial intracranial infection
30 days
- +2 more other outcomes
Study Arms (2)
Early Minimally Invasive Surgery with Thrombolysis (eMIST) plus best medical management (BMM)
EXPERIMENTALSubjects will undergo minimally invasive catheter evacuation followed by up to 10 doses of 50000U of urokinase for intracerebral hemorrhage clot resolution.
Best medical management (BMM)
NO INTERVENTIONSubjects will receive standard of care medical management for ICH.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Age ≥ 18 years;
- Pre-randomization head CT demonstrating an acute, spontaneous, primary ICH;
- ICH volume ≥ 20mL as calculated by the ABC/2 method;
- 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.
- Historical Modified Rankin Score 0 or 1;
- Obtain informed consent from patient or legal representative.
You may not qualify if:
- Infratentorial intraparenchymal hemorrhage including midbrain, pontine, or cerebellar;
- 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;
- Presence of spot sign in CT angiography;
- Blood pressure control before randomization is ineffective, systolic blood pressure \> 220 mmHg;
- Irreversible impaired brain stem function (bilateral fixed, dilated pupils and extensor motor posturing), GCS ≤ 4;
- Intraventricular extension of the Hemorrhage is visually estimated to involve \>50% of either of the lateral ventricles;
- Any irreversible coagulopathy or known clotting disorder.
- Platelet count \< 750,000, INR \> 1.4 after correction
- Patients requiring long-term anti-coagulation that needs to be initiated \< 30 days from index ICH;
- Use of 2 or more antithrombotic drugs prior to symptom onset;
- Patients with a mechanical heart valve;
- Positive urine or serum pregnancy test in female subjects without documented history of surgical sterilization or is post-menopausal;
- Urokinase allergy;
- Any concurrent serious illness that would interfere with the outcome assessments including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, immunologic, and hematologic disease;
- Inability or unwillingness of patient or legal representative to give written informed consent;
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (50)
Guangdong Provincial People's Hospital
Guangdong, Yuexiu, China
Guangde People's Hospital
Anhui, China
Beijing Chao-Yang Hospital, Capital Medical University
Beijing, China
Beijing Daxing District People's Hospital
Beijing, China
Beijing Fengtai You'anmen Hospital
Beijing, China
Beijing Friendship Hospital, Capital Medical University
Beijing, China
Peking University Aerospace Central Hospital
Beijing, China
Shunyi District Hospital in Beijing
Beijing, China
Xuanwu Hospital, Capital Medical University
Beijing, China
Bozhou city people's hospital
Bozhou, China
Changsha Central Hospital
Changsha, China
Changzhi Medical College Affiliated Heji Hospital
Changzhi, China
Chifeng Municipal Hospital
Chifeng, China
Chongqing Emergency Medical Service
Chongqing, China
First Affiliated Hospital of Dalian Medical University
Dalian, China
Fuxin Second People\'s Hospital
Fuxin, China
First Affiliated Hospital of Gannan Medical University
Gannan, China
The Seventh Affiliated Hospital of Southern Medical University
Guangdong, China
The First Hospital of Harbin Medical University
Harbin, China
Affiliated Hospital of Hebei University of Engineering
Hebei, China
The First Affiliated Hospital of Anhui Medical University
Hefei, China
Affiliated Hospital of Inner Mongolia Medical University
Hohhot, China
Jinan City People's Hospital
Jinan, China
Jinan Hospital of Xuanwu Hospital, Capital Medical University
Jinan, China
The First People Hospital of Yunnan Province
Kunming, China
Tibet People's Hospital
Lhasa, China
Liaocheng Brain Hospital
Liaocheng, China
The First Affiliated Hospital of Nanchang University
Nanchang, China
Affiliated Hospital of Nantong University
Nantong, China
Center Hospital of Nanyang
Nanyang, China
Third People's Hospital of Hainan Province
Sanya, China
Shanghai Fourth People's Hospital Affiliated to Tongji University
Shanghai, China
Shanghai Sixth People's Hospital Affiliated to Shanghai JiaoTong University
Shanghai, China
Shanghai Tenth People's Hospital
Shanghai, China
The First Affiliated Hospital of China Medical University
Shenyang, China
The First Hospital of Hebei Medical University
Shijiazhuang, China
Suining Central Hospital
Sichuan, China
Central People's Hospital of Siping City
Siping, China
The Second Affiliated Hospital of Shandong First Medical University
Tai’an, China
Tianjin Huanhu Hospital
Tianjin, China
First Affiliated Hospital of Xinjiang Medical University
Ürümqi, China
Weifang People's Hospital
Weifang, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, China
The Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, China
The First Affiliated Hospital of Xiamen University
Xiamen, China
Xiangyang Central Hospital
Xiangyang, China
Yanan Medical College of Yanan University
Yan’an, China
Henan Provincial People's Hospital
Zhengzhou, China
The Second Affiliated Hospital of Zhengzhou University
Zhengzhou, China
The Fourth People's Hospital of Zigong City
Zigong, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 10, 2025
First Posted
September 23, 2025
Study Start
October 24, 2025
Primary Completion (Estimated)
September 1, 2027
Study Completion (Estimated)
March 1, 2028
Last Updated
March 9, 2026
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- At least 18 months after the publication of the main report.
- Access Criteria
- Written proposals will be assessed by TIME-ICH investigators for appropriateness of use, and a data sharing agreement in accordance with China regulations will be put in place before data is shared.
De-identified data may be shared with other parties to maximize the usefulness of the collected research data. Data can be requested from the principal investigators with a detailed description of the objectives and methods of the study for which the data is intended. Data will be made available for this purpose at least 18 months after the publication of the main report.