Status:
RECRUITING
TrIal of Early Minimally Invasive Catheter Evacuation With Thrombolysis in IntraCerebral Hemorrhage
Lead Sponsor:
Xuanwu Hospital, Beijing
Conditions:
Intracerebral Hemorrhage
Eligibility:
All Genders
18+ years
Phase:
NA
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 t...
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 i...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
October 24 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2028
Estimated Enrollment :
750 Patients enrolled
Trial Details
Trial ID
NCT07187687
Start Date
October 24 2025
End Date
March 1 2028
Last Update
January 6 2026
Active Locations (38)
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1
Guangdong Provincial People's Hospital
Guangdong, Yuexiu, China
2
Beijing Chao-Yang Hospital, Capital Medical University
Beijing, China
3
Beijing Daxing District People's Hospital
Beijing, China
4
Beijing Fengtai You'anmen Hospital
Beijing, China