Minimally Invasive Neuroendoscopic Ultra-Early Targeted ICH Evacuation (MINUTE) Trial
Icahn School of Medicine at Mount Sinai
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).
Eligibility
- Age range
- 18–80 years
- Sex
- All
- 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…
Interventions
- ProcedureEndoscopic 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.
- OtherStandard 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.
Location
- Mount Sinai Health SystemNew York, New York