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

Last updated: March 6, 2026
Sponsor: Xuanwu Hospital, Beijing
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hemorrhage

Stroke

Neurologic Disorders

Treatment

Early Minimally Invasive Surgery with Thrombolysis (eMIST)

Clinical Study ID

NCT07187687
TIME-ICH-2025
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

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 beinitiated within 4 hours after randomization.

  5. Historical Modified Rankin Score 0 or 1;

  6. Obtain informed consent from patient or legal representative.

Exclusion

Exclusion Criteria:

  1. Infratentorial intraparenchymal hemorrhage including midbrain, pontine, orcerebellar;

  2. Ruptured aneurysm, arteriovenous malformation (AVM), vascular anomaly, Moyamoyadisease, venous sinus thrombosis, mass or tumor, hemorrhagic conversion of anischemic infarct, tumor stroke, recurrence of a recent (<1 year) ICH, as diagnosedwith 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 andextensor motor posturing), GCS ≤ 4;

  6. Hemorrhage with apparent midbrain extension with third nerve palsy or dilated andnon-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 daysfrom 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 historyof surgical sterilization or is post-menopausal;

  14. Urokinase allergy;

  15. Any concurrent serious illness that would interfere with the outcome assessmentsincluding hepatic, renal, gastroenterologic, respiratory, cardiovascular,endocrinologic, immunologic, and hematologic disease;

  16. Inability or unwillingness of patient or legal representative to give writteninformed consent;

  17. Known life-expectancy of less than 6 months;

  18. Participation in a concurrent interventional medical investigation or clinicaltrial.

Study Design

Total Participants: 750
Treatment Group(s): 1
Primary Treatment: Early Minimally Invasive Surgery with Thrombolysis (eMIST)
Phase:
Study Start date:
October 24, 2025
Estimated Completion Date:
March 01, 2028

Study 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).

Connect with a study center

  • Guangdong Provincial People's Hospital

    Guangdong, Yuexiu
    China

    Site Not Available

  • Guangdong Provincial People's Hospital

    Guangdong 7545962, Yuexiu
    China

    Site Not Available

  • Guangde People's Hospital

    Anhui,
    China

    Site Not Available

  • Beijing Chao-Yang Hospital, Capital Medical University

    Beijing,
    China

    Site Not Available

  • Beijing Daxing District People's Hospital

    Beijing,
    China

    Active - Recruiting

  • Beijing Fengtai You'anmen Hospital

    Beijing,
    China

    Active - Recruiting

  • Beijing Friendship Hospital, Capital Medical University

    Beijing,
    China

    Active - Recruiting

  • Peking University Aerospace Central Hospital

    Beijing,
    China

    Site Not Available

  • Shunyi District Hospital in Beijing

    Beijing,
    China

    Site Not Available

  • Xuanwu Hospital, Capital Medical University

    Beijing,
    China

    Active - Recruiting

  • Beijing Chao-Yang Hospital, Capital Medical University

    Beijing 1816670,
    China

    Site Not Available

  • Beijing Daxing District People's Hospital

    Beijing 1816670,
    China

    Active - Recruiting

  • Beijing Fangshan District First Hospital

    Beijing 1816670,
    China

    Site Not Available

  • Beijing Fangshan District Liangxiang Hospital

    Beijing 1816670,
    China

    Site Not Available

  • Beijing Fengtai You'anmen Hospital

    Beijing 1816670,
    China

    Active - Recruiting

  • Beijing Friendship Hospital, Capital Medical University

    Beijing 1816670,
    China

    Active - Recruiting

  • Beijing Friendship Pinggu Hospital Affiliated to Capital Medical University

    Beijing 1816670,
    China

    Site Not Available

  • Beijing Tiantan Hospital, Capttal Medical University

    Beijing 1816670,
    China

    Site Not Available

  • Chuiyangliu Hospital affillated with Tsinghua University

    Beijing 1816670,
    China

    Site Not Available

  • Xuanwu Hospital, Capital Medical University

    Beijing 1816670,
    China

    Site Not Available

  • Bozhou city people's hospital

    Bozhou,
    China

    Site Not Available

  • Changsha Central Hospital

    Changsha,
    China

    Active - Recruiting

  • Changsha Central Hospital

    Changsha 1815577,
    China

    Site Not Available

  • Changzhi Medical College Affiliated Heji Hospital

    Changzhi,
    China

    Active - Recruiting

  • Changzhi Medical College Affiliated Heji Hospital

    Changzhi 1808956,
    China

    Site Not Available

  • Chifeng Municipal Hospital

    Chifeng,
    China

    Active - Recruiting

  • Chifeng Municipal Hospital

    Chifeng 2038067,
    China

    Site Not Available

  • Chongqing Emergency Medical Service

    Chongqing,
    China

    Active - Recruiting

  • Chongqing Emergency Medical Service

    Chongqing 1814906,
    China

    Site Not Available

  • First Affiliated Hospital of Dalian Medical University

    Dalian,
    China

    Site Not Available

  • First Affiliated Hospital of Dalian Medical University

    Dalian 1814087,
    China

    Site Not Available

  • Fuxin Second People\'s Hospital

    Fuxin,
    China

    Site Not Available

  • First Affiliated Hospital of Gannan Medical University

    Gannan,
    China

    Site Not Available

  • The Seventh Affiliated Hospital of Southern Medical University

    Guangdong,
    China

    Site Not Available

  • The Second People's Hospital of Guiyang

    Guiyang 1809461,
    China

    Site Not Available

  • The First Hospital of Harbin Medical University

    Harbin,
    China

    Site Not Available

  • The First Hospital of Harbin Medical University

    Harbin 2037013,
    China

    Site Not Available

  • Affiliated Hospital of Hebei University of Engineering

    Hebei,
    China

    Site Not Available

  • The First Affiliated Hospital of Anhui Medical University

    Hefei,
    China

    Active - Recruiting

  • The First Affiliated Hospital of Anhui Medical University

    Hefei 1808722,
    China

    Site Not Available

  • Affiliated Hospital of Inner Mongolia Medical University

    Hohhot,
    China

    Site Not Available

  • Affiliated Hospital of Inner Mongolia Medical University

    Hohhot 2036892,
    China

    Site Not Available

  • Jinan City People's Hospital

    Jinan,
    China

    Active - Recruiting

  • Jinan Hospital of Xuanwu Hospital, Capital Medical University

    Jinan,
    China

    Site Not Available

  • Jinan City People's Hospital

    Jinan 1805753,
    China

    Active - Recruiting

  • Jinan Hospital of Xuanwu Hospital, Capital Medical University

    Jinan 1805753,
    China

    Site Not Available

  • The First People Hospital of Yunnan Province

    Kunming,
    China

    Active - Recruiting

  • The First People Hospital of Yunnan Province

    Kunming 1804651,
    China

    Site Not Available

  • Tibet People's Hospital

    Lhasa,
    China

    Site Not Available

  • Tibet People's Hospital

    Lhasa 1280737,
    China

    Site Not Available

  • Liaocheng Brain Hospital

    Liaocheng,
    China

    Site Not Available

  • Liaocheng Brain Hospital

    Liaocheng 1803834,
    China

    Site Not Available

  • The First Affiliated Hospital of Nanchang University

    Nanchang,
    China

    Active - Recruiting

  • The First Affiliated Hospital of Nanchang University

    Nanchang 1800163,
    China

    Site Not Available

  • Affiliated Hospital of Nantong University

    Nantong,
    China

    Site Not Available

  • Affiliated Hospital of Nantong University

    Nantong 1799722,
    China

    Site Not Available

  • Center Hospital of Nanyang

    Nanyang,
    China

    Site Not Available

  • Center Hospital of Nanyang

    Nanyang 1799629,
    China

    Site Not Available

  • Third People's Hospital of Hainan Province

    Sanya,
    China

    Active - Recruiting

  • Third People's Hospital of Hainan Province

    Sanya 1796556,
    China

    Site Not Available

  • Shanghai Fourth People's Hospital Affiliated to Tongji University

    Shanghai,
    China

    Active - Recruiting

  • Shanghai Sixth People's Hospital Affiliated to Shanghai JiaoTong University

    Shanghai,
    China

    Site Not Available

  • Shanghai Tenth People's Hospital

    Shanghai,
    China

    Active - Recruiting

  • Shanghai Fourth People's Hospital Affiliated to Tongji University

    Shanghai 1796236,
    China

    Site Not Available

  • Shanghai Tenth People's Hospital

    Shanghai 1796236,
    China

    Active - Recruiting

  • The First Affiliated Hospital of China Medical University

    Shenyang,
    China

    Site Not Available

  • The First Hospital of Hebei Medical University

    Shijiazhuang,
    China

    Active - Recruiting

  • The First Hospital of Hebei Medical University

    Shijiazhuang 1795270,
    China

    Site Not Available

  • Suining Central Hospital

    Sichuan,
    China

    Site Not Available

  • Suining Central Hospital

    Sichuan 7348569,
    China

    Site Not Available

  • Central People's Hospital of Siping City

    Siping,
    China

    Active - Recruiting

  • Central People's Hospital of Siping City

    Siping 2034714,
    China

    Site Not Available

  • The Second Affiliated Hospital of Shandong First Medical University

    Tai’an,
    China

    Active - Recruiting

  • The Second Affiliated Hospital of Shandong First Medical University

    Tai’an 1793724,
    China

    Site Not Available

  • Tianjin Huanhu Hospital

    Tianjin,
    China

    Active - Recruiting

  • Tianjin Huanhu Hospital

    Tianjin 1792947,
    China

    Site Not Available

  • Weifang People's Hospital

    Weifang,
    China

    Active - Recruiting

  • Weifang People's Hospital

    Weifang 1791681,
    China

    Site Not Available

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou,
    China

    Active - Recruiting

  • The Second Affiliated Hospital of Wenzhou Medical University

    Wenzhou,
    China

    Site Not Available

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou 1791388,
    China

    Site Not Available

  • Zhongnan Hospital of Wuhan University

    Wuhan 1791247,
    China

    Site Not Available

  • The First Affiliated Hospital of Xiamen University

    Xiamen,
    China

    Site Not Available

  • The First Affiliated Hospital of Xiamen University

    Xiamen 1790645,
    China

    Site Not Available

  • Xiangyang Central Hospital

    Xiangyang,
    China

    Site Not Available

  • Yanan Medical College of Yanan University

    Yan’an,
    China

    Active - Recruiting

  • Yanan Medical College of Yanan University

    Yan’an 1787765,
    China

    Site Not Available

  • General Hospital of Ningxia Medical University

    Yinchuan 1786657,
    China

    Site Not Available

  • Henan Provincial People's Hospital

    Zhengzhou,
    China

    Active - Recruiting

  • The Second Affiliated Hospital of Zhengzhou University

    Zhengzhou,
    China

    Active - Recruiting

  • Henan Provincial People's Hospital

    Zhengzhou 1784658,
    China

    Active - Recruiting

  • The Second Affiliated Hospital of Zhengzhou University

    Zhengzhou 1784658,
    China

    Site Not Available

  • The Fourth People's Hospital of Zigong City

    Zigong,
    China

    Active - Recruiting

  • The Fourth People's Hospital of Zigong City

    Zigong 1783745,
    China

    Site Not Available

  • First Affiliated Hospital of Xinjiang Medical University

    Ürümqi,
    China

    Active - Recruiting

  • First Affiliated Hospital of Xinjiang Medical University

    Ürümqi 1529102,
    China

    Site Not Available

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