Early minimally invasive catheter evacuation with thrombolysis for intracerebral hemorrhage

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

TIME-ICH is a multicenter, randomized, adaptive PROBE trial comparing early minimally invasive surgery with catheter-based clot evacuation plus intraparenchymal thrombolysis (eMIST) to best medical management in adults with spontaneous supratentorial ICH of at least 20 mL. Eligible patients who can be randomized within 8 hours of symptom onset and start the intervention within 4 hours after randomization are allocated 1:1 by central computerized randomization. The trial uses blinded assessment of the 180-day utility-weighted modified Rankin Scale as the primary efficacy endpoint and includes an adaptive sample size re-estimation after 250 patients complete 180-day follow-up. The design aims to determine whether early clot reduction improves long-term functional outcomes compared with medical care alone.

Why it matters

Who can join: the full rules

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.

Where it's running

• Guangdong Provincial People's Hospital
  Guangdong, Yuexiu, China Recruiting
• Baotou Central Hospital
  Baotou, China Recruiting
• Beijing Chao-Yang Hospital, Capital Medical University
  Beijing, China Recruiting
• Beijing Daxing District People's Hospital
  Beijing, China Recruiting
• Beijing Fengtai You'anmen Hospital
  Beijing, China Recruiting
• Beijing Friendship Hospital, Capital Medical University
  Beijing, China Recruiting

+20 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Tao Hong, MD, PhD
• Email: hongtao.edu@gmail.com
• Phone: +86 10 8319 8948

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.