Skip to main content
Back to Trials
NCT07260916NARecruiting

Minimally Invasive Neuroendoscopic Ultra-Early Targeted ICH Evacuation

Weill Medical College of Cornell University

Start Date

7/10/2026

Completion Date

7/31/2030

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 Criteria

Age Range: 18 years to 80 years

Inclusion Criteria: 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. Exclusion Criteria: 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

Interventions

PROCEDURE

Endoscopic ICH evacuation

OTHER

Standard Medical Treatment

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Basal Ganglia Intracerebral Hemorrhage

Locations

Banner University Medical Center - Phoenix

Phoenix, Arizona 85006

United States

Mayo Clinic

Phoenix, Arizona 85054

United States

Banner University Medical Center - Tucson Campus

Tucson, Arizona 85719

United States

Keck Hospital of USC

Los Angeles, California 90033

United States

Cedars-Sinai Medical Center

Los Angeles, California 90048

United States

Ronald Reagan UCLA Medical Center

Los Angeles, California 90095

United States

UC Davis Medical Center

Sacramento, California 95817

United States

John Muir Medical Center - Walnut Creek Campus

Walnut Creek, California 94598

United States

Yale New Haven Hospital

New Haven, Connecticut 06519

United States

Jackson Memorial Hospital

Miami, Florida 33136

United States

Tampa General Hospital

Tampa, Florida 33606

United States

Northwestern Memorial Hospital

Chicago, Illinois 60611

United States

University of Illinois Hospital

Chicago, Illinois 60612

United States

Advocate Lutheran General Hospital

Park Ridge, Illinois 60068

United States

University of Louisville Hospital

Louisville, Kentucky 40202

United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts 02215

United States

Lahey Hospital & Medical Center

Burlington, Massachusetts 01805

United States

University of Mississippi Medical Center

Jackson, Mississippi 39216

United States

University of Missouri Health Care

Columbia, Missouri 65212

United States

SSM Health St. Louis University Hospital

St Louis, Missouri 63104

United States

Washington University - Barnes Jewish Hospital

St Louis, Missouri 63110

United States

University of Nebraska Medical Center

Omaha, Nebraska 68198

United States

Cooper University Hospital

Camden, New Jersey 08103

United States

JFK Medical Center

Edison, New Jersey 08820

United States

Jersey Shore University Medical Center

Neptune City, New Jersey 07753

United States

Robert Wood Johnson University Hospital

New Brunswick, New Jersey 08901

United States

Overlook Medical Center

Summit, New Jersey 07901

United States

Buffalo General Medical Center

Buffalo, New York 14203

United States

NYU Langone Health

New York, New York 10016

United States

The Mount Sinai Hospital

New York, New York 10029

United States

NYP Weill Cornell Medical Center

New York, New York 10065

United States

Oregon Health & Science University Hospital

Portland, Oregon 97239

United States

Geisinger Medical Center

Danville, Pennsylvania 17822

United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania 19104

United States

Avera McKennan Hospital & University Health Center

Sioux Falls, South Dakota 57105

United States

Vanderbilt University Hospital

Nashville, Tennessee 37232

United States

University of Texas Medical Branch

Galveston, Texas 77555

United States

Houston Methodist Hospital

Houston, Texas 77030

United States

Memorial Hermann Texas Medical Center

Houston, Texas 77030

United States

Baylor Scott & White Medical Center

Temple, Texas 76508

United States

University of Utah Healthcare

Salt Lake City, Utah 84132

United States

Harborview Medical Center

Seattle, Washington 98104

United States

J.W. Ruby Memorial Hospital

Morgantown, West Virginia 26506

United States

University of Wisconsin University Hospital

Madison, Wisconsin 53792

United States