TrIal of Early Minimally Invasive Catheter Evacuation With Thrombolysis in IntraCerebral Hemorrhage (NCT07187687) | Clinical Trial Compass
RecruitingNot Applicable
TrIal of Early Minimally Invasive Catheter Evacuation With Thrombolysis in IntraCerebral Hemorrhage
China750 participantsStarted 2025-10-24
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. 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;