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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
750
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.
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.
Time frame: 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.
Time frame: 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
Time frame: 7 days, 14 days (discharge), 30 days, 90 days and 180 days
Mortality
Mortality at 180 days.
Time frame: 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.
Time frame: 36 hours, 7 days and 14 days (discharge)
Health-related quality of life - EQ-5D-5L
Health-related quality of life will be assessed by EuroQol five-dimension, five-level (EQ-5D-5L) which consists of two parts, a short descriptive system questionnaire and a visual analogue scale (EQ VAS) at 7 days, 14 days/discharge, 30 days, 90 days and 180 days.
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Guangdong Provincial People's Hospital
Guangdong, Yuexiu, China
NOT_YET_RECRUITINGGuangde People's Hospital
Anhui, China
NOT_YET_RECRUITINGBeijing Chao-Yang Hospital, Capital Medical University
Beijing, China
NOT_YET_RECRUITINGBeijing Daxing District People's Hospital
Beijing, China
RECRUITINGBeijing Fengtai You'anmen Hospital
Beijing, China
RECRUITINGBeijing Friendship Hospital, Capital Medical University
Beijing, China
RECRUITINGPeking University Aerospace Central Hospital
Beijing, China
NOT_YET_RECRUITINGShunyi District Hospital in Beijing
Beijing, China
NOT_YET_RECRUITINGXuanwu Hospital, Capital Medical University
Beijing, China
RECRUITINGBozhou city people's hospital
Bozhou, China
NOT_YET_RECRUITING...and 40 more locations
Time frame: 14 days (discharge), 30 days, 90 days and 180 days
Activities of Daily Living - Barthel Index
Activities of Daily Living will be assessed by Barthel Index at 14 days/discharge, 30 days, 90 days and 180 days.
Time frame: 14 days (discharge), 30 days, 90 days and 180 days