Minimally Invasive Neuroendoscopic Ultra-Early Targeted ICH Evacuation (MINUTE) Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 300
- Locations
- 45
- Primary Endpoint
- Mortality (all-cause)
Study Overview
Brief 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 <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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
MINUTE is an on-label study with a blinded end-point outcome assessment, i.e. participants, providers, and site investigators will not be blinded to treatment assignments. Blinding is difficult, if not impossible, from a clinical perspective. It is not possible to blind the Investigator who treats the patient, the clinical staff, or the research team. Physicians treating participants who experience an AE after must know how the hemorrhage was treated in order to effectively report the AE and plan further treatment. However, MINUTE will require that study-related follow-up assessments be conducted by blinded investigators certified in mRS assessment, who were not involved in clinical care of the participant and are unaware of the patient's randomization status. A large Band-Aid will be placed on every patient's forehead prior to blinded assessor review, thereby preventing scar visualization or misinterpretation of unrelated scars on control patients.
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •CTA or MRA is performed and does not show an underlying vascular lesion
- •Pre-ICH mRS 0-2
- •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)
- •The treating physician anticipates that surgery can be initiated <120 min from randomization
- •Randomization within 16 hours from LKW and within 2 hours of arrival to the randomizing center.
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
Arms & Interventions
Endoscopic ICH evacuation (SCUBA) and Standard Medical Treatment
Participants will be treated with SCUBA and Standard Medical Treatment
Intervention: Endoscopic ICH evacuation (Procedure)
Endoscopic ICH evacuation (SCUBA) and Standard Medical Treatment
Participants will be treated with SCUBA and Standard Medical Treatment
Intervention: Standard Medical Treatment (Other)
Standard Medical Treatment
Participants will be treated with Standard Medical Treatment
Intervention: Standard Medical Treatment (Other)
Outcomes
Primary Outcomes
Mortality (all-cause)
Time Frame: Day 30
Number of mortalities, for any reason, at day 30
Utility-Weighted Modified Rankin Scale (UW-mRS)
Time Frame: Day 180
Utility-Weighted Modified Rankin Scale (UW-mRS), a tool used primarily in stroke research to measure a patient's disability. It assigns a "utility" value (representing quality of life) to each level of the standard Modified Rankin Scale (mRS) to provide a more nuanced, patient-centered outcome measure than the mRS alone. The utility weighted mRS scales the 0-6 mRS range onto a 0-1 range, with higher scores indicating better health outcomes.
Secondary Outcomes
- Number of successful endoscopic clot removal(during procedure)
- Number of post-procedural complications adverse events(up to 30 days)
- Number of CNS infection(Day 30)
- Mortality (all-cause)(Day 30)
- Peri-cavity edema (PCE)(24 hour)
- Number of successful endoscopic clot removal(during procedure)
- Number of CNS infection(Day 30)
- Number of post-procedural complications adverse events(up to 30 days)
- Volume of clot remaining post endoscopic clot removal(24 hours post procedure)
- Mortality (all-cause)(Day 30)
Investigators
J. Mocco
National Principal Investigator
Icahn School of Medicine at Mount Sinai