About this trial
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
Qualifiers
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.
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Early Minimally Invasive Surgery with Thrombolysis (eMIST)