NCT07187687 TrIal of Early Minimally Invasive Catheter Evacuation With Thrombolysis in IntraCerebral Hemorrhage
| NCT ID | NCT07187687 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Xuanwu Hospital, Beijing |
| Condition | Intracerebral Hemorrhage |
| Study Type | INTERVENTIONAL |
| Enrollment | 750 participants |
| Start Date | 2025-10-24 |
| Primary Completion | 2027-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 750 participants in total. It began in 2025-10-24 with a primary completion date of 2027-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: 1. Age ≥ 18 years; 2. Pre-randomization head CT demonstrating an acute, spontaneous, primary ICH; 3. ICH volume ≥ 20mL as calculated by the ABC/2 method; 4. 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. 5. Historical Modified Rankin Score 0 or 1; 6. Obtain informed consent from patient or legal representative. Exclusion Criteria: 1. Infratentorial intraparenchymal hemorrhage including midbrain, pontine, or cerebellar; 2. 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; 3. Presence of spot sign in CT angiography; 4. Blood pressure control before randomization is ineffective, systolic blood pressure \> 220 mmHg; 5. Irreversible impaired brain stem function (bilateral fixed, dilated pupils and extensor motor posturing), GCS ≤ 4; 6. Hemorrhage with apparent midbrain extension with third nerve palsy or dilated and non-reactive pupils. Other (supranuclear) gaze abnormalities are not exclusions; 7. Intraventricular extension of the Hemorrhage is visually estimated to involve \>50% of either of the lateral ventricles; 8. Any irreversible coagulopathy or known clotting disorder. 9. Platelet count \< 750,000, INR \> 1.4 after correction 10. Patients requiring long-term anti-coagulation that needs to be initiated \< 30 days from index ICH; 11. Use of 2 or more antithrombotic drugs prior to symptom onset; 12. Patients with a mechanical heart valve; 13. Positive urine or serum pregnancy test in female subjects without documented history of surgical sterilization or is post-menopausal; 14. Urokinase allergy; 15. Any concurrent serious illness that would interfere with the outcome assessments including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, immunologic, and hematologic disease; 16. Inability or unwillingness of patient or legal representative to give written informed consent; 17. Known life-expectancy of less than 6 months; 18. Participation in a concurrent interventional medical investigation or clinical trial.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07187687 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Intracerebral Hemorrhage. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07187687 currently recruiting?
Yes, NCT07187687 is actively recruiting participants. Contact the research team at hongtao.edu@gmail.com for enrollment information.
Where is the NCT07187687 trial being conducted?
This trial is being conducted at Guangdong, China, Anhui, China, Beijing, China, Beijing, China and 11 additional locations.
Who is sponsoring the NCT07187687 clinical trial?
NCT07187687 is sponsored by Xuanwu Hospital, Beijing. The trial plans to enroll 750 participants.