Race against time: can surgery within hours save brain bleed patients?

NCT ID NCT07260916

Disease control Sponsor: Weill Medical College of Cornell University Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Sep 16, 2026 · Updated 4 times

Summary

This trial tests whether removing a brain bleed with a minimally invasive scope within hours of symptoms improves recovery. 300 adults with a specific type of brain bleed will be randomly assigned to either get the surgery plus standard care, or standard care alone. The study will track disability and quality of life for one year.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: minimally invasive endoscopic surgery (SCUBA approach)
What this could lead to: If successful, this could establish a new standard for ultra-early surgical removal of brain bleeds, potentially improving survival and quality of life for stroke patients.
What could go wrong: This is an early-stage trial (Phase NA) with a small sample size (300). The surgery is invasive and carries risks like infection or rebleeding. Results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2026

Expected to finish

Jul 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

intracerebral hemorrhage

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Basal ganglia intracerebral hemorrhage

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

44 sites. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

Advocate Lutheran General Hospital
NOT_YET_RECRUITING

Park Ridge, Illinois, 60068, United States
Avera McKennan Hospital & University Health Center
NOT_YET_RECRUITING

Sioux Falls, South Dakota, 57105, United States
Banner University Medical Center - Phoenix
NOT_YET_RECRUITING

Phoenix, Arizona, 85006, United States
Banner University Medical Center - Tucson Campus
NOT_YET_RECRUITING

Tucson, Arizona, 85719, United States
Baylor Scott & White Medical Center
RECRUITING

Temple, Texas, 76508, United States
Beth Israel Deaconess Medical Center
NOT_YET_RECRUITING

Boston, Massachusetts, 02215, United States
Buffalo General Medical Center
NOT_YET_RECRUITING

Buffalo, New York, 14203, United States
Cedars-Sinai Medical Center
RECRUITING

Los Angeles, California, 90048, United States
Cooper University Hospital
NOT_YET_RECRUITING

Camden, New Jersey, 08103, United States
Geisinger Medical Center
NOT_YET_RECRUITING

Danville, Pennsylvania, 17822, United States
Harborview Medical Center
NOT_YET_RECRUITING

Seattle, Washington, 98104, United States
Hospital of the University of Pennsylvania
NOT_YET_RECRUITING

Philadelphia, Pennsylvania, 19104, United States
Houston Methodist Hospital
NOT_YET_RECRUITING

Houston, Texas, 77030, United States
J.W. Ruby Memorial Hospital
NOT_YET_RECRUITING

Morgantown, West Virginia, 26506, United States
JFK Medical Center
NOT_YET_RECRUITING

Edison, New Jersey, 08820, United States
Jackson Memorial Hospital
NOT_YET_RECRUITING

Miami, Florida, 33136, United States
Jersey Shore University Medical Center
NOT_YET_RECRUITING

Neptune City, New Jersey, 07753, United States
John Muir Medical Center - Walnut Creek Campus
NOT_YET_RECRUITING

Walnut Creek, California, 94598, United States
Keck Hospital of USC
NOT_YET_RECRUITING

Los Angeles, California, 90033, United States
Lahey Hospital & Medical Center
RECRUITING

Burlington, Massachusetts, 01805, United States
Mayo Clinic
NOT_YET_RECRUITING

Phoenix, Arizona, 85054, United States
Memorial Hermann Texas Medical Center
NOT_YET_RECRUITING

Houston, Texas, 77030, United States
NYP Weill Cornell Medical Center
RECRUITING

New York, New York, 10065, United States
NYU Langone Health
RECRUITING

New York, New York, 10016, United States
Northwestern Memorial Hospital
NOT_YET_RECRUITING

Chicago, Illinois, 60611, United States
Oregon Health & Science University Hospital
NOT_YET_RECRUITING

Portland, Oregon, 97239, United States
Overlook Medical Center
NOT_YET_RECRUITING

Summit, New Jersey, 07901, United States
Robert Wood Johnson University Hospital
RECRUITING

New Brunswick, New Jersey, 08901, United States
Ronald Reagan UCLA Medical Center
RECRUITING

Los Angeles, California, 90095, United States
SSM Health St. Louis University Hospital
NOT_YET_RECRUITING

St Louis, Missouri, 63104, United States
Tampa General Hospital
RECRUITING

Tampa, Florida, 33606, United States
The Mount Sinai Hospital
RECRUITING

New York, New York, 10029, United States
UC Davis Medical Center
NOT_YET_RECRUITING

Sacramento, California, 95817, United States
University of Illinois Hospital
NOT_YET_RECRUITING

Chicago, Illinois, 60612, United States
University of Louisville Hospital
NOT_YET_RECRUITING

Louisville, Kentucky, 40202, United States
University of Mississippi Medical Center
NOT_YET_RECRUITING

Jackson, Mississippi, 39216, United States
University of Missouri Health Care
NOT_YET_RECRUITING

Columbia, Missouri, 65212, United States
University of Nebraska Medical Center
NOT_YET_RECRUITING

Omaha, Nebraska, 68198, United States
University of Texas Medical Branch
NOT_YET_RECRUITING

Galveston, Texas, 77555, United States
University of Utah Healthcare
NOT_YET_RECRUITING

Salt Lake City, Utah, 84132, United States
University of Wisconsin University Hospital
NOT_YET_RECRUITING

Madison, Wisconsin, 53792, United States
Vanderbilt University Hospital
NOT_YET_RECRUITING

Nashville, Tennessee, 37232, United States
Washington University - Barnes Jewish Hospital
NOT_YET_RECRUITING

St Louis, Missouri, 63110, United States
Yale New Haven Hospital
RECRUITING

New Haven, Connecticut, 06519, United States