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NCT07187687
TrIal of Early Minimally Invasive Catheter Evacuation With Thrombolysis in IntraCerebral Hemorrhage
Conditions: Intracerebral Hemorrhage
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 750
Sponsor: Xuanwu Hospital, Beijing
Location: Guangdong Provincial People's Hospital Guangdong Yuexiu
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 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 be initiated within 4 hours after randomization.
5. Historical Modified Rankin Score 0 or 1;
6. Obtain informed consent from patient or legal representative.
Exclusion Criteria:
1. Infratentorial intraparenchymal hemorrhage including midbrain, pontine, or cerebellar;
2. 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 (\ 220 mmHg;
5. Irreversible impaired brain stem function (bilateral fixed, dilated pupils and extensor motor posturing), GCS ≤ 4;
6. Hemorrhage with apparent midbrain extension with third nerve palsy or dilated and non-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 days from 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 history of surgical sterilization or is post-menopausal;
14. Urokinase allergy;
15. Any concurrent serious illness that would interfere with the outcome assessments including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, immunologic, and hematologic disease;
16. Inability or unwillingness of patient or legal representative to give written informed consent;
17. Known life-expectancy of less than 6 months;
18. Participation in a concurrent interventional medical investigation or clinical trial.
Source: ClinicalTrials.gov (NCT07187687). StuddyBuddy aggregates publicly available trial information.