Minimally Invasive Neuroendoscopic Ultra-Early Targeted ICH Evacuation (MINUTE)

Mount Sinai Health System

Status: Begins enrollment this month

Conditions: Basal Ganglia Intracerebral Hemorrhage

Treatments: Procedure: Endoscopic ICH evacuation; Other: Standard Medical Treatment

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07260916

GCO 23-1905

1UG3NS138638-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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 <7 days following ictus)
• The treating physician anticipates that surgery can be initiated <120 min from randomization
• Randomization can occur ≤16 hours from LKW

Exclusion criteria

• 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 Infratentorial or thalamic hemorrhage
• Midbrain extension/involvement
• Coagulopathy defined as international normalized ratio (INR) > 1.4
• Elevated activated Partial Thromboplastin Time (aPTT) > 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 <100 x 103 cells/mm3, or known platelet dysfunction (reversal of coagulopathy is not allowed) GCS score <7 at presentation
• Evidence of active infection indicated by fever ≥100.7 °F and/or open draining wound at the time of enrollment
• Any comorbid disease or condition expected to compromise survival or ability to complete follow-up assessments through 365 days
• Intraventricular extension of the hemorrhage is visually estimated to involve > 50% of either of the lateral ventricles
• Pregnancy (women of childbearing potential must have a negative pregnancy test to participate)
• 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
• Current participation in another interventional (drug or device) trial
• Pre-existing Do Not Resuscitate (DNR)/Do Not Intubate (DNI) status
• History of severe dementia

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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300 participants in 2 patient groups, including a placebo group

Endoscopic ICH evacuation (SCUBA) and Standard Medical Treatment

Experimental group

Description:

Participants will be treated with SCUBA and Standard Medical Treatment

Treatment:

Other: Standard Medical Treatment

Procedure: Endoscopic ICH evacuation

Standard Medical Treatment

Placebo Comparator group

Description:

Participants will be treated with Standard Medical Treatment

Treatment:

Other: Standard Medical Treatment