TrIal of Early Minimally Invasive Catheter Evacuation With Thrombolysis in IntraCerebral Hemorrhage

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorXuanwu Hospital, Beijing

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)

Treatment groups

750 Participants
are divided into 2 treatment groups

Sponsors and collaborators