NCT07187687

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

TrIal of Early Minimally Invasive Catheter Evacuation With Thrombolysis in IntraCerebral Hemorrhage (TIME-ICH): A Prospective, Multi-center, Open-label, Adaptive, Randomized Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 750 (estimated)
• Sponsor: Xuanwu Hospital, Beijing · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Patients presenting to the emergency department with stroke due to supratentorial, spontaneous intracerebral hemorrhage ≥20mL volume will be assessed to determine their eligibility for randomization into the trial. If the patient gives informed consent they will be randomized 1:1 using central computerized allocation to early minimally invasive surgery with thrombolysis versus best medical management. The trial is prospective, randomized, open-label, blinded endpoint (PROBE) design. Adaptive sample size re-estimation will be performed when 250 patients have completed 180 days follow-up. Clinical efficacy will be determined by demonstrating an improvement in functional outcome, as determined by a blinded-assessment of the 180-day utility-weighted modified Rankin Scale (mRS).

Conditions

• Intracerebral Hemorrhage

Interventions

Type	Name	Description
PROCEDURE	Early Minimally Invasive Surgery with Thrombolysis (eMIST)	Subjects 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.

Timeline

• Start date: 2025-10-24
• Primary completion: 2027-09-01
• Completion: 2028-03-01
• First posted: 2025-09-23
• Last updated: 2026-03-09

Locations

50 sites across 1 country: China