An interventional study of Early Minimally Invasive Surgery with Thrombolysis (eMIST) in Intracerebral Hemorrhage, sponsored by Xuanwu Hospital, Beijing. Recruiting at 70 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by Xuanwu Hospital, Beijing · Not applicable, Interventional, and Treatment
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).
457 studies on the registry are indexed under Cerebral Hemorrhage; 172 are open to participants now.
This study's planned enrollment of 750 is above the median of 100 across 269 interventional studies indexed under Cerebral Hemorrhage.
Browse Cerebral Hemorrhage studies →Xuanwu Hospital, Beijing is the lead sponsor of 363 studies on the registry; 230 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects will undergo minimally invasive catheter evacuation followed by up to 10 doses of 50000U of urokinase for intracerebral hemorrhage clot resolution.
Procedure: Early Minimally Invasive Surgery with Thrombolysis (eMIST)
Subjects will receive standard of care medical management for ICH.
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.
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
Safety - All Cause Mortality
Safety will be assessed by mortality from all causes at 30 days.
Time frame: 30 days
Safety - Procedure-Related Mortality
Safety will be assessed by procedure-related mortality at 7 days.
Time frame: 7 days
Safety - Bacterial intracranial infection
Safety will be assessed by brain bacterial infection events at 30 days.
Time frame: 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.
Time frame: 72 hours after last dose
Economic
Economic differential as determined by quantification of the cost per quality-adjusted life-years (QALY) gained through eMIST.
Time frame: 14 days (discharge), 30 days, 90 days and 180 days.
Plan to share: Yes — De-identified data may be shared with other parties to maximize the usefulness of the collected research data. Data can be requested from the principal investigators with a detailed description of the objectives and methods of the study for which the data is intended. Data will be made available for this purpose at least 18 months after the publication of the main report.
Supporting information: Study protocol, Statistical analysis plan
Time frame: At least 18 months after the publication of the main report.
Access criteria: Written proposals will be assessed by TIME-ICH investigators for appropriateness of use, and a data sharing agreement in accordance with China regulations will be put in place before data is shared.
No publications or documents are linked to this record.
Started Oct 2025 (actual). Primary completion is estimated for Sep 2027, 22 months after the start.
Of 76 non-industry interventional studies with no phase under Cerebral Hemorrhage, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 58. This study's planned 22 months is below that.
Counting every sponsor, half of 84 studies reached it within 38 months; a quarter within 19 and three quarters within 72.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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