Minimally Invasive Endoscopic Evacuation for Basal Ganglia ICH

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

MINUTE is a multicenter randomized trial that compares endoscopic evacuation plus standard medical care to standard medical care alone in adults with spontaneous basal ganglia ICH ≥20 mL. Participants are randomized in two cohorts based on time from onset (<8 hours or 8–16 hours) and are enrolled to receive treatment within about 2 hours of randomization. The primary follow-up assessments include adverse events and the utility-weighted modified Rankin Scale at 30, 90, 180, and 365 days. The study uses a blinded assessor design with adaptive enrichment to refine enrollment targets as data accumulate. Eligible participants must have relatively preserved pre-ICH function and no underlying vascular lesion identified by imaging.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age ≥ 18 and ≤ 80 years
2. Non-traumatic, spontaneous, supratentorial, non-thalamic, BGH of volume ≥ 20 mL, as determined by the treating physician using ABC/2 method
3. NIHSS ≥ 6 at presentation
4. CTA or MRA is performed and does not show an underlying vascular lesion
5. Pre-ICH mRS 0-2
6. Informed consent from patient or LAR to participate in the trial, wherein patient/LAR's stated wishes are to pursue lifesaving therapies as opposed to early withdrawal of care (explicitly explained as \<7 days following ictus)
7. The treating physician anticipates that surgery can be initiated \<120 min from randomization
8. Randomization within 16 hours from LKW and within 2 hours of arrival to the randomizing center.

Exclusion Criteria:

1. Suspected secondary cause for the ICH, such as an underlying vascular malformation (cavernous malformation, arteriovenous malformation, etc.), aneurysm, neoplasm, hemorrhagic transformation of an underlying ischemic infarct; or venous infarct
2. Infratentorial or thalamic hemorrhage
3. Midbrain extension/involvement
4. Coagulopathy defined as international normalized ratio (INR) \> 1.4
5. Elevated activated Partial Thromboplastin Time (aPTT) \> 40 s
6. Concurrent use of direct oral anticoagulants or low molecular weight heparin at ICH onset
7. Known hereditary or acquired hemorrhagic diathesis or coagulation factor deficiency
8. Platelet count \<100 x 103 cells/mm3, or known platelet dysfunction (reversal of coagulopathy is not allowed)
9. GCS score \<7 at presentation
10. Evidence of active infection indicated by fever ≥100.7 °F and/or open draining wound at the time of enrollment
11. Any comorbid disease or condition expected to compromise survival or ability to complete follow-up assessments through 365 days
12. Intraventricular extension of the hemorrhage is visually estimated to involve \> 50% of either of the lateral ventricles
13. Pregnancy (women of childbearing potential must have a negative pregnancy test to participate)
14. Based on investigator's judgment, the patient does not have the necessary mental capacity to participate or is unwilling to comply with the protocol follow-up schedule
15. Current participation in another interventional (drug or device) trial
16. Pre-existing Do Not Resuscitate (DNR)/Do Not Intubate (DNI) status
17. History of severe dementia

Where it's running

• Cedars-Sinai Medical Center
  Los Angeles, California, United States Recruiting
• Ronald Reagan UCLA Medical Center
  Los Angeles, California, United States Recruiting
• Yale New Haven Hospital
  New Haven, Connecticut, United States Recruiting
• Tampa General Hospital
  Tampa, Florida, United States Recruiting
• Lahey Hospital & Medical Center
  Burlington, Massachusetts, United States Recruiting
• Robert Wood Johnson University Hospital
  New Brunswick, New Jersey, United States Recruiting

Study contacts

• Principal investigator: J Mocco, MD, MS — Weill Medical College of Cornell University
• Study coordinator: Ally Qi, MPH
• Email: alq4003@med.cornell.edu
• Phone: 209-330-3024

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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.