RecruitingBasal Ganglia Intracerebral Hemorrhage

Minimally Invasive Neuroendoscopic Ultra-Early Targeted ICH Evacuation

Eligible age

18–80 yrs

Accepts

All genders

Locations

21 states

Healthy volunteers

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About this study

MINUTE is a prospective, multi-center, randomized, controlled, blinded assessor, adaptive enrichment design, clinical trial. Eligible patients with spontaneous BGH ≥20 mL will be randomized 1:1 to either minimally invasive endoscopic SCUBA evacuation plus standard medical management or standard medical management alone; the time of randomization will be used to classify participants in one of two cohorts: 1) those randomized \<8 hours from onset, and 2) those randomized 8-16 hours from onset. Randomization is targeted to occur within 120 min of arrival to the randomizing center's Emergency Department (ED), and initiation of surgery is targeted to occur within 120 min of randomization. Participants will be followed at 30, 90, 180, and 365 days to assess for adverse events (AEs) and utility-weighted modified Rankin Scale (UW-mRS).

Sponsor: Weill Medical College of Cornell University

You may qualify if…

✓ 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.

You may not qualify if…

✕ 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)