Minimally Invasive Neuroendoscopic Ultra-Early Targeted ICH Evacuation

Official title

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

Overview

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).

Interventions

• 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 tra
• 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.

Primary outcome measures

• Utility-Weighted Modified Rankin Scale (UW-mRS) [Time frame: Day 180]

Secondary outcome measures (5)

• Number of successful endoscopic clot removal [Time frame: during procedure]
• Volume of clot remaining post endoscopic clot removal [Time frame: 24 hours post procedure]
• Number of post-procedural complications adverse events [Time frame: up to 30 days]
• Number of CNS infection [Time frame: Day 30]
• Mortality (all-cause) [Time frame: Day 30]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

United States · 2 centers

• Robert Wood Johnson University Hospital — New Brunswick
• Mount Sinai Health System — New York

Identifiers

NCT: NCT07260916 · GCO 23-1905 · 1UG3NS138638-01A1

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗