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.
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.
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;
Parallel
Early Minimally Invasive Surgery with Thrombolysis (eMIST)
Procedure/SurgerySubjects will undergo minimally invasive catheter evacuation in the early stage of intracranial hemorrhage. Up to 10 doses of 50000U of urokinase will be administered through the catheter that was placed directly into the intracerebral hemorrhage.
Functional Improvement - uw-mRS
Functional Improvement as determined by utility-weighted modified Rankin Scale (uw-mRS) which is assigned to seven levels: 1.0, 0.91, 0.76, 0.65, 0.33, 0.0, and 0.0 (with higher scores indicating a better outcome, according to patients' assessment) at 180-days.
Functional Improvement - uw-mRS
Functional Improvement as determined by utility-weighted modified Rankin Scale (uw-mRS) which is assigned to seven levels: 1.0, 0.91, 0.76, 0.65, 0.33, 0.0, and 0.0 (with higher scores indicating a better outcome, according to patients' assessment) at 7 days, 14 days/discharge, 30 days and 90 days.
Functional Improvement - good functional outcome
Good functional outcome as determined by modified Rankin Scale (mRS) 0-3 at 7 days, 14 days/discharge, 30 days, 90 days and 180 days
Mortality
Mortality at 180 days.
Clot Removal - Amount of Residual Blood
Clot Removal will be assessed by the amount of residual blood at 36 hours, 7 days and 14 days/discharge.
Safety - All Cause Mortality
Safety will be assessed by mortality from all causes at 30 days.
Safety - Procedure-Related Mortality
Safety will be assessed by procedure-related mortality at 7 days.
Safety - Bacterial intracranial infection
Safety will be assessed by brain bacterial infection events at 30 days.
Safety - Symptomatic Brain Bleeding Within 72 Hours After Last Dose
Safety will be assessed by adjudicated symptomatic brain bleeding events within 30 days.
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