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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 \

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07260916). StuddyBuddy aggregates publicly available trial information.