Minimally Invasive Neuroendoscopic Ultra-Early Targeted ICH Evacuation

Purpose

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).

Condition

  • Basal Ganglia Intracerebral Hemorrhage

Eligibility

Eligible Ages
Between 18 Years and 80 Years
Eligible 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 - 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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Adult patients (18-80 years old) with spontaneous Basal Ganglia (BG) intracerebral hemorrhage (ICH) ≥20 mL able to be randomized for endoscopic evacuation within 16 hours of ICH onset or last known well (LKW). Endoscopic minimally invasive Stereotactic Cerebral Underwater Blood Aspiration (SCUBA) of spontaneous basal ganglia ICH (BGH)
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.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Endoscopic ICH evacuation (SCUBA) and Standard Medical Treatment 		Participants will be treated with SCUBA and Standard Medical Treatment
  • Procedure: Endoscopic ICH evacuation
    The intervention is minimally invasive endoscopic ICH evacuation using the SCUBA approach29. Stereotactic guidance must be used to guide placement of the sheath into the hematoma. Using stereotactic guidance software, a trajectory is planned along the long axis of the hematoma to the skull while avoiding eloquent brain regions, prominent vasculature, and other anatomy that should not be traversed during the approach, such as the frontal sinuses. A tele-proctor will be available to review the trajectory prior to the procedure starting. The procedure is performed under general anesthesia. The patient's head can be fixed if required depending on the stereotactic navigation system used.
    Other names:
    • SCUBA
  • Other: Standard Medical Treatment
    Participating physicians will attest that they will manage all ICH patients in the medical and surgical arms of the trial according to their institutional standards of care, which they will attest are consistent with the American Stroke Association guidelines for management of spontaneous ICH66 and utilize a standardized blood pressure management and hydrocephalus management protocol.
Placebo Comparator
Standard Medical Treatment 		Participants will be treated with Standard Medical Treatment
  • Procedure: Endoscopic ICH evacuation
    The intervention is minimally invasive endoscopic ICH evacuation using the SCUBA approach29. Stereotactic guidance must be used to guide placement of the sheath into the hematoma. Using stereotactic guidance software, a trajectory is planned along the long axis of the hematoma to the skull while avoiding eloquent brain regions, prominent vasculature, and other anatomy that should not be traversed during the approach, such as the frontal sinuses. A tele-proctor will be available to review the trajectory prior to the procedure starting. The procedure is performed under general anesthesia. The patient's head can be fixed if required depending on the stereotactic navigation system used.
    Other names:
    • SCUBA
  • Other: Standard Medical Treatment
    Participating physicians will attest that they will manage all ICH patients in the medical and surgical arms of the trial according to their institutional standards of care, which they will attest are consistent with the American Stroke Association guidelines for management of spontaneous ICH66 and utilize a standardized blood pressure management and hydrocephalus management protocol.

Recruiting Locations

Robert Wood Johnson University Hospital
New Brunswick, New Jersey 08901

Mount Sinai Health System
New York, New York 10029
Contact:
Emily Svendsen
212-241-3238
emily.svendsen@mountsinai.org

More Details

Status
Recruiting
Sponsor
Icahn School of Medicine at Mount Sinai

Study Contact

Ally Qi, MPH
2093303024
ally.qi@mountsinai.org