Minimally Invasive Neuroendoscopic Ultra-Early Targeted ICH Evacuation

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorIcahn School of Medicine at Mount Sinai

About this trial

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).

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Endoscopic ICH evacuation
  • Standard Medical Treatment

Treatment groups

300 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Icahn School of Medicine at Mount Sinai

Lead sponsor

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Beth Israel Deaconess Medical Center

Collaborator

Medical University of South Carolina

Collaborator

NINDS Stroke Trials Network (StrokeNet)

Collaborator