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NCT06870812NARecruiting

Rapid Evacuation and Access of Cerebral Hemorrhage Trial

Emory University

Start Date

5/27/2025

Completion Date

3/1/2030

Summary

The main purpose of this study is to compare patients with a deep bleed in the brain undergoing surgery to patients receiving routine medical care. The standard treatment involves admission to the Intensive Care Unit (ICU) with close monitoring and blood pressure control. It also includes other medical (non-surgical) treatments to prevent more bleeding or another stroke. Sometimes, doctors will recommend surgery to remove the blood if medical treatment alone is not successful. There is evidence that doing minimally invasive surgery early-using a small opening in the skull to remove blood-may help some patients. Researchers aim to understand whether this surgery is better than current medical treatment, which may include surgeries to relieve pressure on the brain in some cases. This study, called REACH, is comparing usual medical care to early minimally invasive surgery so doctors can know which is better for patients.

Detailed Description

The REACH trial, which stands for Rapid Evacuation and Access of Cerebral Hemorrhage Trial, is a medical research study aimed at finding better ways to treat people who have had a specific type of stroke called an intracerebral hemorrhage. This type of stroke happens when a blood vessel bursts and causes bleeding in the brain. Traditionally, treating this kind of stroke has been challenging, and the best approach is not always clear. Recently, trials have shown that minimally invasive surgery to remove the clot caused by bleeding improves outcomes and decreases death when the blood is located closer to the surface of the skull. The REACH trial is testing the same minimally invasive surgery to remove the blood clot caused by the bleeding in a deeper part of the brain. The goal is to see if this approach can improve recovery and outcomes for patients compared to standard medical care. In simple terms, the REACH trial is trying to find out if using a less invasive surgical technique can help people recover better and faster after a bleeding stroke in the deeper part of the brain.

Eligibility Criteria

Age Range: 18 years to 70 years

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

Interventions

PROCEDURE

Surgical management

OTHER

Medical Management

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Conditions

Stroke Hemorrhagic

Locations

University of Arkansas for Medical Sciences

Little Rock, Arkansas 72205

United States

Stanford University Medical Center

Palo Alto, California 94304

United States

Baptist Health Jacksonville FL

Jacksonville, Florida 32207

United States

Baptist Health South Florida

Kendall, Florida 33176

United States

Jackson Memorial Hospital (JMH)

Miami, Florida 33125

United States

Grady Memorial Hospital

Atlanta, Georgia 30303

United States

Emory Hospital Midtown

Atlanta, Georgia 30308

United States

Emory University Hospital (EUH)

Atlanta, Georgia 30322

United States

Rush University

Chicago, Illinois 60612

United States

Endeavor Health, Northshore

Evanston, Illinois 60201

United States

Goodman Campbell Brain and Spine

Carmel, Indiana 46032

United States

University of Kentucky

Lexington, Kentucky 40536

United States

Johns Hopkins School of Medicine

Baltimore, Maryland 21287

United States

University of Missouri

Columbia, Missouri 65212

United States

Albany Medical Center

Albany, New York 12208

United States

SUNY Upstate Medical University

Syracuse, New York 13210

United States

Montefiore Medical Center/Albert Einstein School of Medicine

The Bronx, New York 10467

United States

The Ohio State University

Columbus, Ohio 43210

United States

ProMedica Toledo Hospital

Toledo, Ohio 43606

United States

Rhode Island Hospital/Brown University Health

Providence, Rhode Island 02912

United States

Vanderbilt University Medical Center

Nashville, Tennessee 37232

United States