Recruiting

Minimally Invasive Surgery vs. Medical Care

Sponsor:

Emory University

Code:

NCT06870812

Conditions

Stroke Hemorrhagic

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Surgical management

Medical Management

Study Details

Brief 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.

Conditions

Stroke Hemorrhagic

Study ID

NCT06870812

Start date

May 27, 2025

Status verified date

Aug, 2026

Completion date

Mar, 2030

Anticipated

Primary completion date

Mar, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

600 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Surgical management (MIPS) plus medical management

Participants randomized to surgical management will follow the Medical Manual of the Clinical Standardization Guidelines (CSG) before and after surgery.

active comparator: medical management.

Participants randomized to the medical management alone will be treated according to the Clinical Standardization Guidelines (CSG).

Interventions

Surgical management

Following randomization into the surgical arm, a competency-trained neurosurgeon will perform the MIPS for clot evacuation with strict adherence to the Surgical Manual of the CSG. Image interpretation, patient position, anesthetic plan, stereotactic navigation registration, exoscopic positioning, access, optics, resection, and hemostasis are detailed in the Surgical Manual of the CSG.

The OR arrival time should occur <24 hours from the last known normal (LKN) with a goal of arrival in less than 8 hours from the last known normal.

Medical Management

Following randomization into the medical arm patients will be treated following the Medical Manual of the CSG. The Medical Manual has been adapted by the REACH Executive Committee (REC) from the current American Heart Association (AHA) and American Stroke Association (ASA) Guidelines for the Management of Spontaneous Intracerebral Hemorrhage. Whenever clinically feasible, the CSG should be followed as it represents a template for the care of these subjects.

The Medical Manual details specialty level of care, including intensive care placement, blood pressure control, hemostasis and coagulopathy, anemia, deep venous thrombosis and pulmonary embolism prophylaxis/treatment, glucose management, temperature management, seizure prophylaxis, intracranial pressure monitoring and management, intraventricular hemorrhage (IVH)/obstructive hydrocephalus management, cerebral edema, decompressive hemicraniectomy, nutritional support, respiratory support, and comfort care.

Primary outcome measure

  • Score on the modified Rankin Scale (mRS) at [ Time Frame: 180 days after randomization ]

Central Contacts and Locations

Central contacts

Alex Hall, DHSc

404-778-1585alex.hall@emory.edu

Locations

University of Arkansas for Medical Sciences

Recruiting

Little Rock, Arkansas, United States, 72205

Contacts

Kennetha Newman

NewmanKennethaL@uams.edu

Principal Investigator:

Deanna Sasaki-Adams, MD

Baptist Health Jacksonville FL

Recruiting

Jacksonville, Florida, United States, 32207

Contacts

Dollie Jennings, Ph.D.

904-202-7063Sarah.jennings@bmc.edu

Principal Investigator:

Ricardo Hanel, MD, PhD

Baptist Health South Florida

Recruiting

Kendall, Florida, United States, 33176

Contacts

Marianela A Cruz

marianela.cruz@baptisthealth.net

Sukie Hernandez

Sukie.Hernandez@baptisthealth.net

Principal Investigator:

Robert Wicks, MD

University of Miami Health System, Jackson Memorial Hospital

Recruiting

Miami, Florida, United States, 33125

Contacts

Ahmed Abdelsalam

aaa824@med.miami.edu

Principal Investigator:

Robert Starke, MD

Grady Memorial Hospital

Recruiting

Atlanta, Georgia, United States, 30303

Contacts

Garet Michael, MBA, MPH

404.778.1711Garett.michael@emory.edu

Principal Investigator:

Aqueel Pabaney, MD

Emory Hospital Midtown

Recruiting

Atlanta, Georgia, United States, 30308

Contacts

Garet Michael, MBA, MPH

404.778.1711Garett.michael@emory.edu

Principal Investigator:

Tomas Garzon-Muvdi, MD

Emory University Hospital (EUH)

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Connor McMillan, BS

404-727-1337connor.mcmillan@emory.edu

Principal Investigator:

Brian Howard, MD

Endeavor Health, Northshore

Recruiting

Evanston, Illinois, United States, 60201

Contacts

Boris Jancan, MD, CCRP

847-570-3674bjancan@northshore.org

Principal Investigator:

Shakeel Chowdhry, MD

St Vincent Hospital/Goodman Campbell Brain and Spine

Recruiting

Indianapolis, Indiana, United States, 46260

Contacts

Luke Watkins, RN, BSN, CCRP

317-565-3572lwatkins@goodmancampbell.com

Principal Investigator:

Charles Kulwin, MD

University of Kentucky Health Care, Kentucky Neuroscience Institute

Recruiting

Lexington, Kentucky, United States, 40536

Contacts

Rachel Norris

rachel.norris@uky.edu

Principal Investigator:

David Dornbos, MD

Johns Hopkins School of Medicine

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Whitney Isennock

wwebb10@jh.edu

Principal Investigator:

Justin Caplan, MD

University of Missouri

Recruiting

Columbia, Missouri, United States, 65212

Contacts

Brooke Hoffman

hoffmanba@health.missouri.edu

Principal Investigator:

Michael Chicoine, MD

Albany Medical Center

Recruiting

Albany, New York, United States, 12208

Contacts

Chelsey Large

largec@amc.edu

Principal Investigator:

Alexandra Paul, MD

SUNY Upstate Medical University

Recruiting

Syracuse, New York, United States, 13210

Contacts

Lena Deb

315-464-9756DebL@upstate.edu

Principal Investigator:

Timothy Beutler, MD, FAANS

ProMedica Toledo Hospital

Recruiting

Toledo, Ohio, United States, 43606

Contacts

Melanie Pakulski

melanie.pakulski@promedica.org

Principal Investigator:

Kevin Reinard, MD

Rhode Island Hospital/Brown University Health

Recruiting

Providence, Rhode Island, United States, 02912

Contacts

Mei Tiemeyer

mtiemeyer@brownhealth.org

Principal Investigator:

Krisztina Moldovan, MD

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Anna Bican

anna.bican@vumc.org

Principal Investigator:

Matthew Fusco, MD

More Information

Sponsor

Emory University

Last update posted

Aug 14, 2026

Last verified

Aug, 2026

Keywords

  • Intracerebral hemorrhage
  • minimally invasive surgery
  • Blood clot

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Emory University on 2026-08-14.