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

Recruiting now · Not applicable

Conditions studied: Intracerebral Hemorrhage

In brief

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.

Key facts

Study ID

NCT07187687

Run by

Xuanwu Hospital, Beijing

People needed

750

Starts

2025-10-24

Expected to finish

2028-03-01

Last updated by the study team

2026-03-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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;
• Hemorrhage with apparent midbrain extension with third nerve palsy or dilated and non-reactive pupils. Other (supranuclear) gaze abnormalities are not exclusions;
• 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.

Where it is running

• Beijing Fengtai You'anmen Hospital — Beijing, China (enrolling)
• The First Affiliated Hospital of Nanchang University — Nanchang, China (enrolling)
• Xuanwu Hospital, Capital Medical University — Beijing, China (enrolling)
• Beijing Friendship Hospital, Capital Medical University — Beijing, China (enrolling)
• Third People's Hospital of Hainan Province — Sanya, China (enrolling)
• Shanghai Fourth People's Hospital Affiliated to Tongji University — Shanghai, China (enrolling)
• Changsha Central Hospital — Changsha, China (enrolling)
• Shanghai Tenth People's Hospital — Shanghai, China (enrolling)
• Changzhi Medical College Affiliated Heji Hospital — Changzhi, China (enrolling)
• The First Hospital of Hebei Medical University — Shijiazhuang, China (enrolling)
• The First Affiliated Hospital of Anhui Medical University — Hefei, China (enrolling)
• Central People's Hospital of Siping City — Siping, China (enrolling)
• The Second Affiliated Hospital of Shandong First Medical University — Tai’an, China (enrolling)
• Tianjin Huanhu Hospital — Tianjin, China (enrolling)
• First Affiliated Hospital of Xinjiang Medical University — Ürümqi, China (enrolling)
• Weifang People's Hospital — Weifang, China (enrolling)
• The First Affiliated Hospital of Wenzhou Medical University — Wenzhou, China (enrolling)
• Chifeng Municipal Hospital — Chifeng, China (enrolling)
• Jinan City People's Hospital — Jinan, China (enrolling)
• Chongqing Emergency Medical Service — Chongqing, China (enrolling)
• Yanan Medical College of Yanan University — Yan’an, China (enrolling)
• Henan Provincial People's Hospital — Zhengzhou, China (enrolling)
• The Second Affiliated Hospital of Zhengzhou University — Zhengzhou, China (enrolling)
• The Fourth People's Hospital of Zigong City — Zigong, China (enrolling)
• The First People Hospital of Yunnan Province — Kunming, China (enrolling)

Full record on ClinicalTrials.gov

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