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Brain bleed breakthrough? new trial tests early surgery against standard care

NCT ID NCT06870812

Disease control Sponsor: Emory University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 14, 2026 · Updated 1 time

Summary

This study looks at whether doing a small surgery early to remove blood from a deep brain bleed helps patients more than standard medical care. About 600 adults aged 18 to 70 with a specific type of brain bleed will take part. The goal is to see which approach leads to better recovery and fewer deaths.

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 600 people

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

Started

May 2025

Expected to finish

Mar 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 70 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: * Age 18-70 years * Pre-randomization head CT demonstrating an acute, spontaneous, anterior basal ganglia primary intracerebral hemorrhage (ICH) (the anterior basal ganglia include the caudate, putamen, and pallidum to the capsula externa and excludes the thalamus) * ICH volume between 20 - 80 mL as calculated by an approved and standardized volumetric measurement * Study intervention can reasonably be initiated within 24 hours after the onset of stroke symptoms. If the onset is unclear, then the onset will be considered the time that the subject was last known to be well. * Glasgow Coma Score (GCS) 5 - 14 * Historical Modified Rankin Score 0 or 1 Exclusion Criteria: * Ruptured aneurysm, arteriovenous malformation (AVM), vascular anomaly, Moyamoya disease, venous sinus thrombosis, mass or tumor, hemorrhagic conversion of an ischemic infarct, recurrence of a recent (less than 1 year) ICH, as diagnosed with radiographic imaging * NIH Stroke Scale (NIHSS) less than or equal to 5 * Bilateral fixed dilated pupils * Extensor motor posturing * Intraventricular extension of the hemorrhage is visually estimated to involve greater than 50% of either of the lateral ventricles * Primary thalamic ICH or basal ganglia hemorrhage with involvement \> 25% of thalamus * Infratentorial intraparenchymal hemorrhage including midbrain, pontine, or cerebellar * Use of anticoagulants that cannot be rapidly reversed (i.e., criteria is met if investigators are confident that clinically significant coagulopathy is not present after targeted correction) * Evidence of active bleeding involving a retroperitoneal, gastrointestinal, genitourinary, or respiratory tract site * Uncorrected coagulopathy or known clotting disorder * Known platelet count less than 75,000 or known international normalized ratio (INR) greater than 1.4 after correction * Patients requiring long-term anti-coagulation that needs to be initiated less than or equal to 5 days from initial ICH * End-stage renal disease * Patients with a mechanical heart valve * End-stage liver disease * History of drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements * Positive urine or serum pregnancy test in female subjects without documented history of surgical sterilization or post-menopausal * Known life expectancy of less than 6 months before ICH * No reasonable expectation of recovery, do-not-resuscitate (DNR), or comfort measures only before randomization * Participation in a concurrent interventional medical investigation or clinical trial. Patients in non-interventional/observational studies are eligible * Inability or unwillingness of the subject or legal guardian/representative to give written informed consent * Homelessness or inability to meet follow-up requirements

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Conditions

The condition(s) this trial relates to.

Hemorrhagic Stroke intracerebral hemorrhage thrombotic disease

As listed by the trial registrant

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

Stroke hemorrhagic

How to take part

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

  1. The places running it

    24 sites. The list below names each one and where it is.

  2. 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 ↗

  3. 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 Aurora Research Institute

    NOT_YET_RECRUITING

    Park Ridge, Illinois, 60068, United States

  • Albany Medical Center

    RECRUITING

    Albany, New York, 12208, United States

  • Baptist Health Jacksonville FL

    RECRUITING

    Jacksonville, Florida, 32207, United States

  • Baptist Health South Florida

    RECRUITING

    Kendall, Florida, 33176, United States

  • Emory Hospital Midtown

    RECRUITING

    Atlanta, Georgia, 30308, United States

  • Emory University Hospital (EUH)

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Endeavor Health, Northshore

    RECRUITING

    Evanston, Illinois, 60201, United States

  • Grady Memorial Hospital

    RECRUITING

    Atlanta, Georgia, 30303, United States

  • Johns Hopkins School of Medicine

    RECRUITING

    Baltimore, Maryland, 21287, United States

  • Montefiore Medical Center/Albert Einstein School of Medicine

    NOT_YET_RECRUITING

    The Bronx, New York, 10467, United States

  • Ohio State University

    NOT_YET_RECRUITING

    Columbus, Ohio, 43210, United States

  • Penn State Milton S. Hershey Medical Center

    NOT_YET_RECRUITING

    Hershey, Pennsylvania, 17033, United States

  • ProMedica Toledo Hospital

    RECRUITING

    Toledo, Ohio, 43606, United States

  • RUSH University Medical Center

    NOT_YET_RECRUITING

    Chicago, Illinois, 60612, United States

  • Rhode Island Hospital/Brown University Health

    RECRUITING

    Providence, Rhode Island, 02912, United States

  • SUNY Upstate Medical University

    RECRUITING

    Syracuse, New York, 13210, United States

  • St Vincent Hospital/Goodman Campbell Brain and Spine

    RECRUITING

    Indianapolis, Indiana, 46260, United States

  • Stanford University Medical Center

    NOT_YET_RECRUITING

    Palo Alto, California, 94304, United States

  • University of Alabama at Birmingham

    NOT_YET_RECRUITING

    Birmingham, Alabama, 35294, United States

  • University of Arkansas for Medical Sciences

    RECRUITING

    Little Rock, Arkansas, 72205, United States

  • University of Kentucky Health Care, Kentucky Neuroscience Institute

    RECRUITING

    Lexington, Kentucky, 40536, United States

  • University of Miami Health System, Jackson Memorial Hospital

    RECRUITING

    Miami, Florida, 33125, United States

  • University of Missouri

    RECRUITING

    Columbia, Missouri, 65212, United States

  • Vanderbilt University Medical Center

    RECRUITING

    Nashville, Tennessee, 37232, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.