Intracerebral HemorrhageTIME-ICHNCT07187687
TrIal of Early Minimally Invasive Catheter Evacuation With Thrombolysis in IntraCerebral Hemorrhage
A study testing Early Minimally Invasive Surgery with Thrombolysis (eMIST) in people with Intracerebral Hemorrhage, run by Xuanwu Hospital, Beijing at 70 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracerebral Hemorrhage
- What is being tested?
- Early Minimally Invasive Surgery with Thrombolysis (eMIST)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 750 participants
- Where
- 70 sitesChina
- Study dates
- 24 Oct 2025to 1 Mar 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
- Hemorrhage with apparent midbrain extension with third nerve palsy or dilated and non-reactive pupils. Other (supranuclear) gaze abnormalities are not exclusions;
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- 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;
- Known life-expectancy of less than 6 months;
- Participation in a concurrent interventional medical investigation or clinical trial.
Trial locations and contacts
70 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Shaohua Mo, MD contact
70 sites in 1 country
China70 sites, 70 recruiting
- Recruiting
Baotou Central Hospital
Baotou
zhanhua Shi, 13947239986, 274140441@qq.com
- Recruiting
Beijing Chao-Yang Hospital, Capital Medical University
Beijing
Yang Wang, +86 15901016917, 15110299052@163.com
- Recruiting
Beijing Daxing District People's Hospital
Beijing
Jun Zheng, +86 18510111714, zjcc1979@163.com
- Recruiting
Beijing Fengtai You'anmen Hospital
Beijing
Lijian Ni, MD, +86 18612586780, nlijian@163.com
- Recruiting
Beijing Friendship Hospital, Capital Medical University
Beijing
Xianzeng Tong, +86 13811879286, noahtong@163.com
- Recruiting
Peking University Aerospace Central Hospital
Beijing
feng yin, 13381207600, 16564583@qq.com
- Recruiting
Shunyi District Hospital in Beijing
Beijing
zhaobo nie
- Recruiting
Xuanwu Hospital, Capital Medical University
Beijing
Ye Li, MD, +86 10 8319 8948, yli@xwhosp.org
- Recruiting
Bozhou city people's hospital
Bozhou
ruming deng
- Recruiting
Changsha Central Hospital
Changsha
Tianyu Fan, +86 13787781879, 284562765@qq.com
- Recruiting
Changzhi Medical College Affiliated Heji Hospital
Changzhi
Jianhong Li, +86 18636531236, Ljh20081219@163.com
- Recruiting
The First People's Hospital of Changzhou
Changzhou
wei guan, 13961195153, davi989@126.com
- Recruiting
Chifeng Municipal Hospital
Chifeng
Di Zhu, +86 18047661866, Durenfeidoctor@163.com
- Recruiting
Chongqing Emergency Medical Service
Chongqing
Yongbing Deng, +86 13996267066, 1422495819@qq.com
- Recruiting
Chongqing Red Cross Hospital
Chongqing
pu cai, 15825990255, caipu666@163.com
- Recruiting
People's Hospital of Chongqing Banan District
Chongqing
Jianhong huo, 13638382467, bnyyhjh@163.com
- Recruiting
First Affiliated Hospital of Dalian Medical University
Dalian
Bin Dong, +86 18098876129, stocktondb@163.com
- Recruiting
Fujian Zhangzhou Municipal Hospital
Fujian
weiping Cai, 13709399831, zzsyycwp@126.com
- Not yet recruiting
Fuxin Second People\'s Hospital
Fuxin
jian Zhang
- Recruiting
Fuyang People's Hospital
Fuyang
zhibo gao, 15215659898, sunpengju2009@aliyun.com
- Recruiting
First Affiliated Hospital of Gannan Medical University
Gannan
muyun luo
- Recruiting
Guangdong Provincial People's Hospital
Guangdong, Yuexiu
Guangzhong Chen, +86 13925121826, Chengz9732@163.com
- Not yet recruiting
The Seventh Affiliated Hospital of Southern Medical University
Guangdong
weizhao chen
- Not yet recruiting
Guiyang Second People's Hospital
Guiyang
yunsong li, 13985123966, 318807768@qq.com
- Recruiting
Handan Central Hospital
Handan
jianliang wu, 13633315091, 12242728@qq.com
- Recruiting
The First Hospital of Harbin Medical University
Harbin
Chunxu Li, +86 18846810546, 727784295@qq.com
- Not yet recruiting
Affiliated Hospital of Hebei University of Engineering
Hebei
xiushan Li
- Recruiting
The First Affiliated Hospital of Anhui Medical University
Hefei
Yu Qian, +86 18054099598, flyheart_001@qq.com
- Recruiting
Affiliated Hospital of Inner Mongolia Medical University
Hohhot
Naikang Gao, +86 18004713399, gaonaikang@163.com
- Recruiting
Huizhou First People's Hospital
Huizhou
yituan xie, 15812508004, xyt39410@163.com
- Recruiting
Jinan City People's Hospital
Jinan
Xiangdong Lu, +86 18806349698, xiangdonglu@126.com
- Recruiting
Jinan Hospital of Xuanwu Hospital, Capital Medical University
Jinan
Dianwei Liu, +86 13370587726, dianwei1982@163.com
- Recruiting
The First People Hospital of Yunnan Province
Kunming
Shuai Zhou, +86 18987180731, zshuai1984@163.com
- Recruiting
Tibet People's Hospital
Lasa
Huandong Liu, +86 19908997888, Liuhuandong2002@163.com
- Not yet recruiting
Liaocheng Brain Hospital
Liaocheng
Zhengang Ji, +86 13563560125, aijizhengang@126.com
- Recruiting
Linshu County People'S Hospital
Linyi
yilan ma, 13791597302, 2414894181@qq.com
- Recruiting
The First Affiliated Hospital of Nanchang University
Nanchang
Jian Duan, +86 13970856345, 21514292@qq.com
- Not yet recruiting
The First People's Hospital of Nanning
Nanning
huasheng fan, 15878196781, 1074656429@qq.com
- Recruiting
Affiliated Hospital of Nantong University
Nantong
Jianhong Shen, +86 13962708058, tysjh@163.com
- Recruiting
Center Hospital of Nanyang
Nanyang
Jianding Zhang, +86 13608452798, nwszjd@163.com
- Recruiting
Xingan League People's Hospita
Neimeng
zhiqiang Li, 13847991396, 1790016827@qq.com
- Recruiting
The First Affiliated Hospital of Ningbo University
Ningbo
sheng nie, 15867265882, niesheng@163.com
- Recruiting
University of Chinese Academy of Sciences Ningbo Huamei Hospital
Ningbo
kai Wang, 18858050678, 12881515@qq.com
- Recruiting
Quzhou People's Hospital
Quzhou
guofeng yu, 18905708948, 184905109@qq.com
- Recruiting
Third People's Hospital of Hainan Province
Sanya
Gang Li, +86 13907559645, lig0550@126.com
- Recruiting
Shanghai Fourth People's Hospital Affiliated to Tongji University
Shanghai
Zhiwen Zhang, +86 13693035972, zhangzw304@sina.com
- Recruiting
Shanghai Sixth People's Hospital Affiliated to Shanghai JiaoTong University
Shanghai
hao Chen
- Recruiting
Shanghai Tenth People's Hospital
Shanghai
Xianzhen Chen, +86 13901793331, chenxianzheny@126.com
- Recruiting
First Hospital of Shanxi Medical University
Shanxi
dahai Wan, 13403451338, 13403451338@163.com
- Recruiting
The First Affiliated Hospital of China Medical University
Shenyang
zhifeng wen
- Recruiting
The First Hospital of China Medical University
Shenyang
zhifeng Wen, 13998216711
- Recruiting
The First Hospital of Hebei Medical University
Shijiazhuang
Conghui Li, +86 13363880072, 13363880072@163.com
- Recruiting
Taihe Hospital in Shiyan City
Shiyan
xiangjun tang, 15971878418, tangxiang_jun@163.com
- Recruiting
Suining Central Hospital
Sichuan
Weimin Li, +86 18808258362, l676912882@126.com
- Recruiting
Central People's Hospital of Siping City
Siping
Xiaodong Li, +86 13843436488, lxd19760115@126.com
- Recruiting
The Second Affiliated Hospital of Shandong First Medical University
Tai’an
Fangmin Xie, +86 13583812796, 1977_1@sina.com
- Recruiting
Tangshan Workers' Hospita
Tangshan
kaijie wang
- Recruiting
Tianjin Huanhu Hospital
Tianjin
Hongguang Wang
- Recruiting
First Affiliated Hospital of Xinjiang Medical University
Ürümqi
Hu Qin, +86 18699147876, qinhu86@163.com
- Recruiting
Weifang People's Hospital
Weifang
Yuting Wang, +86 15253669990, 15253669990@163.com
- Recruiting
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou
Chengde Wang, +86 15888299291, wangcd291@126.com
- Not yet recruiting
The Second Affiliated Hospital of Wenzhou Medical University
Wenzhou
lisheng yu
- Recruiting
The First Affiliated Hospital of Xiamen University
Xiamen
sifang chen
- Recruiting
Xiangyang Central Hospital
Xiangyang
feng chen
- Recruiting
Yanan Medical College of Yanan University
Yan’an
Yunfeng Jia, +86 13891188388, 13891188388@163.com
- Recruiting
Yichang Central People's Hospital
Yichang
chunlei tian, 13697273165, 1580131546@qq.com
- Recruiting
Zhangjiajie City People's Hospital
Zhangjiajie
wei wu, 15874424333, badapple_520@126.com
- Recruiting
Henan Provincial People's Hospital
Zhengzhou
Rongjun Qian, +86 15037138200, qrjqqx@163.com
- Recruiting
The Second Affiliated Hospital of Zhengzhou University
Zhengzhou
Genwei Wang, +86 15824800692, 15824800692@163.com
- Recruiting
The Fourth People's Hospital of Zigong City
Zigong
chenghao yang
About this study
Official title: TrIal of Early Minimally Invasive Catheter Evacuation With Thrombolysis in IntraCerebral Hemorrhage (TIME-ICH): A Prospective, Multi-center, Open-label, Adaptive, Randomized Controlled Trial
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.
Read the detailed description
Patients presenting to the emergency department with stroke due to supratentorial, spontaneous intracerebral hemorrhage ≥20mL volume will be assessed to determine their eligibility for randomization into the trial. If the patient gives informed consent they will be randomized 1:1 using central computerized allocation to early minimally invasive surgery with thrombolysis versus best medical management. The trial is prospective, randomized, open-label, blinded endpoint (PROBE) design. Adaptive sample size re-estimation will be performed when 250 patients have completed 180 days follow-up. Clinical efficacy will be determined by demonstrating an improvement in functional outcome, as determined by a blinded-assessment of the 180-day utility-weighted modified Rankin Scale (mRS).
- Conditions
- Intracerebral Hemorrhage
- Being tested
- Early Minimally Invasive Surgery with Thrombolysis (eMIST)
- Keywords
- Intracerebral Hemorrhage, Intracranial Hemorrhages, ICH, brain hemorrhage, Hemorrhage, Cerebrovascular Disorders, Brain Diseases, Minimally invasive catheter evacuation, Minimally invasive surgery, Neurosurgery, Thrombolysis, Urokinase, Medical Economic, Hospital Economics
- Medical subject headings
- Cerebral Hemorrhage, Intracranial Hemorrhages, Hemorrhage, Cerebrovascular Disorders, Brain Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Minimally Invasive Surgery with Thrombolysis (eMIST)Procedure or surgery
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 group | Role | What they receive |
|---|---|---|
| Early Minimally Invasive Surgery with Thrombolysis (eMIST) plus best medical management (BMM) | Experimental | Subjects will undergo minimally invasive catheter evacuation followed by up to 10 doses of 50000U of urokinase for intracerebral hemorrhage clot resolution. Receives: Procedure: Early Minimally Invasive Surgery with Thrombolysis (eMIST) |
| Best medical management (BMM) | No intervention | Subjects will receive standard of care medical management for ICH. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 180 days
Secondary outcomes (6)
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 7 days, 14 days/discharge, 30 days and 90 days.
Measured: 7 days, 14 days (discharge), 30 days and 90 days
Functional Improvement - good functional outcome
Good functional outcome as determined by modified Rankin Scale (mRS) 0-3 at 7 days, 14 days/discharge, 30 days, 90 days and 180 days
Measured: 7 days, 14 days (discharge), 30 days, 90 days and 180 days
Mortality
Mortality at 180 days.
Measured: 180 days
Clot Removal - Amount of Residual Blood
Clot Removal will be assessed by the amount of residual blood at 36 hours, 7 days and 14 days/discharge.
Measured: 36 hours, 7 days and 14 days (discharge)
Health-related quality of life - EQ-5D-5L
Health-related quality of life will be assessed by EuroQol five-dimension, five-level (EQ-5D-5L) which consists of two parts, a short descriptive system questionnaire and a visual analogue scale (EQ VAS) at 7 days, 14 days/discharge, 30 days, 90 days and 180 days.
Measured: 14 days (discharge), 30 days, 90 days and 180 days
Activities of Daily Living - Barthel Index
Activities of Daily Living will be assessed by Barthel Index at 14 days/discharge, 30 days, 90 days and 180 days.
Measured: 14 days (discharge), 30 days, 90 days and 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2025
- Study start24 Oct 2025
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracerebral HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07187687
- Sponsor's protocol ID
- TIME-ICH-2025
- Acronym
- TIME-ICH
- Status last verified
- Sep 2026
- First submitted
- 10 Sep 2025
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.