Summary

Eligibility
for people ages 18-80 (full criteria)
Location
at UC Davis UCLA
Dates
study started
study ends around
Principal Investigator
by Paul Vespa, MD (ucla)Ben Waldau, MD (ucdavis)
Headshot of Ben Waldau
Ben Waldau

Description

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).

Official Title

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

Keywords

Basal Ganglia Intracerebral Hemorrhage, Basal Ganglia, SCUBA, Intracerebral Hemorrhage, Cerebral Hemorrhage, Endoscopic ICH evacuation

Eligibility

You can join if…

Open to people ages 18-80

  1. Age ≥ 18 and ≤ 80 years
  2. Non-traumatic, spontaneous, supratentorial, non-thalamic, BGH of volume ≥ 20 mL, as determined by the treating physician using ABC/2 method
  3. NIHSS ≥ 6 at presentation
  4. CTA or MRA is performed and does not show an underlying vascular lesion
  5. Pre-ICH mRS 0-2
  6. 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)
  7. The treating physician anticipates that surgery can be initiated <120 min from randomization
  8. Randomization within 16 hours from LKW and within 2 hours of arrival to the randomizing center.

You CAN'T join if...

  1. 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
  2. Infratentorial or thalamic hemorrhage
  3. Midbrain extension/involvement
  4. Coagulopathy defined as international normalized ratio (INR) > 1.4
  5. Elevated activated Partial Thromboplastin Time (aPTT) > 40 s
  6. Concurrent use of direct oral anticoagulants or low molecular weight heparin at ICH onset
  7. Known hereditary or acquired hemorrhagic diathesis or coagulation factor deficiency
  8. Platelet count <100 x 103 cells/mm3, or known platelet dysfunction (reversal of coagulopathy is not allowed)
  9. GCS score <7 at presentation
  10. Evidence of active infection indicated by fever ≥100.7 °F and/or open draining wound at the time of enrollment
  11. Any comorbid disease or condition expected to compromise survival or ability to complete follow-up assessments through 365 days
  12. Intraventricular extension of the hemorrhage is visually estimated to involve > 50% of either of the lateral ventricles
  13. Pregnancy (women of childbearing potential must have a negative pregnancy test to participate)
  14. 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
  15. Current participation in another interventional (drug or device) trial
  16. Pre-existing Do Not Resuscitate (DNR)/Do Not Intubate (DNI) status
  17. History of severe dementia

Locations

  • Ronald Reagan UCLA Medical Center accepting new patients
    Los Angeles California 90095 United States
  • UC Davis Medical Center not yet accepting patients
    Sacramento California 95817 United States
  • Cedars-Sinai Medical Center accepting new patients
    Los Angeles California 90048 United States
  • Keck Hospital of USC not yet accepting patients
    Los Angeles California 90033 United States
  • John Muir Medical Center - Walnut Creek Campus not yet accepting patients
    Walnut Creek California 94598 United States

Lead Scientists at University of California Health

  • Paul Vespa, MD (ucla)
    Dr. Paul Vespa holds the Gary L. Brinderson Family Chair in Neuro-Intensive Care.
  • Ben Waldau, MD (ucdavis)
    Professor, Med: Neurological Surgery, School of Medicine. Authored (or co-authored) 68 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Weill Medical College of Cornell University
ID
NCT07260916
Study Type
Interventional
Participants
Expecting 300 study participants
Last Updated