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Recruiting
NCT07260916
Minimally Invasive Neuroendoscopic Ultra-Early Targeted ICH Evacuation
Conditions: Basal Ganglia Intracerebral Hemorrhage
Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: No
Phase: NA
Enrollment: 300
Sponsor: Icahn School of Medicine at Mount Sinai
Location: Robert Wood Johnson University Hospital New Brunswick New Jersey
Summary
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 \
Eligibility Criteria
Inclusion Criteria:
* Age ≥ 18 and ≤ 80 years
* Non-traumatic, spontaneous, supratentorial, non-thalamic, BGH of volume ≥ 20 mL, as determined by the treating physician using ABC/2 method
* NIHSS ≥ 6 at presentation
* Computed Tomography Angiography (CTA) or Magnetic Resonance Angiography (MRA) is performed and does not show an underlying vascular lesion
* Pre-ICH mRS 0-2 Informed consent from patient or legally authorized representative (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 \ 40 s
* Concurrent use of direct oral anticoagulants or low molecular weight heparin at ICH onset
* Known hereditary or acquired hemorrhagic diathesis or coagulation factor deficiency
* Platelet count \
Source: ClinicalTrials.gov (NCT07260916). StuddyBuddy aggregates publicly available trial information.