Rapid Evacuation and Access of Cerebral Hemorrhage Trial (REACH)

March 17, 2026 updated by: Alex Hall, Emory University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Not yet recruiting
        • University of Arkansas for Medical Sciences
        • Principal Investigator:
          • Deanna Sasaki-Adams, MD
        • Contact:
    • California
      • Palo Alto, California, United States, 94304
        • Not yet recruiting
        • Stanford University Medical Center
        • Contact:
        • Principal Investigator:
          • Robert Dodd, MD
    • Florida
      • Jacksonville, Florida, United States, 32207
        • Recruiting
        • Baptist Health Jacksonville FL
        • Principal Investigator:
          • Ricardo Hanel, MD, PhD
        • Contact:
      • Kendall, Florida, United States, 33176
        • Not yet recruiting
        • Baptist Health South Florida
        • Principal Investigator:
          • Robert Starke, MD
        • Contact:
      • Miami, Florida, United States, 33125
        • Not yet recruiting
        • Jackson Memorial Hospital (JMH)
        • Principal Investigator:
          • Robert Starke, MD
        • Contact:
    • Georgia
      • Atlanta, Georgia, United States, 30303
        • Recruiting
        • Grady Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Aqueel Pabaney, MD
      • Atlanta, Georgia, United States, 30308
        • Recruiting
        • Emory Hospital Midtown
        • Contact:
        • Principal Investigator:
          • Tomas Garzon-Muvdi, MD
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Emory University Hospital (EUH)
        • Contact:
        • Principal Investigator:
          • Brian Howard, MD
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Not yet recruiting
        • Rush University
        • Contact:
        • Principal Investigator:
          • Webster Crowley, MD, FAANS
      • Evanston, Illinois, United States, 60201
        • Recruiting
        • Endeavor Health, Northshore
        • Principal Investigator:
          • Shakeel Chowdhry, MD
        • Contact:
    • Indiana
      • Carmel, Indiana, United States, 46032
        • Not yet recruiting
        • Goodman Campbell Brain and Spine
        • Contact:
        • Principal Investigator:
          • Charles Kulwin, MD
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Not yet recruiting
        • University Of Kentucky
        • Contact:
        • Principal Investigator:
          • David Dornbos
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Not yet recruiting
        • Johns Hopkins School of Medicine
        • Principal Investigator:
          • Justin Caplan, MD
        • Contact:
    • Missouri
      • Columbia, Missouri, United States, 65212
        • Not yet recruiting
        • University of Missouri
        • Principal Investigator:
          • Michael Chicoine, MD
        • Contact:
    • New York
      • Albany, New York, United States, 12208
        • Recruiting
        • Albany Medical Center
        • Principal Investigator:
          • Alexandra Paul, MD
        • Contact:
      • Syracuse, New York, United States, 13210
        • Recruiting
        • SUNY Upstate Medical University
        • Contact:
        • Principal Investigator:
          • Timothy Beutler, MD, FAANS
      • The Bronx, New York, United States, 10467
        • Not yet recruiting
        • Montefiore Medical Center/Albert Einstein School of Medicine
        • Contact:
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Not yet recruiting
        • The Ohio State University
        • Principal Investigator:
          • Patrick Youssef
        • Contact:
      • Toledo, Ohio, United States, 43606
    • Rhode Island
      • Providence, Rhode Island, United States, 02912
        • Recruiting
        • Rhode Island Hospital/Brown University Health
        • Principal Investigator:
          • Krisztina Moldovan, MD
        • Contact:
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Not yet recruiting
        • Vanderbilt University Medical Center
        • Contact:
        • Principal Investigator:
          • Matthew Fusco, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Procedure: 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.

Other Names:
  • Early minimally invasive parafascicular surgery (MIPS)
Other: 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.

Other Names:
  • Standard of Care (SOC)
Active Comparator: medical management.
Participants randomized to the medical management alone will be treated according to the Clinical Standardization Guidelines (CSG).
Other: 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.

Other Names:
  • Standard of Care (SOC)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Score on the modified Rankin Scale (mRS) at
Time Frame: 180 days after randomization
The mRS is a seven-level ordinal scale that ranges from 0 (no symptoms) to 6 (death).
180 days after randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital mortality
Time Frame: Up to 14 days (average hospital stay)
Mortality rate during hospitalization will be calculated.
Up to 14 days (average hospital stay)
All-cause mortality at discharge from the initial hospitalization
Time Frame: 30 days after randomization
All-cause mortality rate will be calculated.
30 days after randomization
Change in hematoma volume
Time Frame: Baseline and up to 36 hours post-randomization
The change in hematoma volume from the initial to the follow-up neuroimaging for surgical management versus medical management.
Baseline and up to 36 hours post-randomization
Post-operative rebleeding associated with neurologic deterioration
Time Frame: Up to 36 hours post-randomization

Post-operative rebleeding associated with neurologic deterioration (defined as a growth in hematoma volume between the initial CT and follow-up neuroimaging and an increase of 4 or more points on the NIH stroke scale or a decrease of up to 2 points on the GCS that was not explained by planned medical interventions [e.g., sedatives, analgesics, and procedures]).

*This outcome applies to the surgery group only.
Up to 36 hours post-randomization
Serious adverse events
Time Frame: 180-days post-randomization
All adverse events will be recorded f after randomization until the final follow-up visit.
180-days post-randomization
Number of participants who required a decompressive hemicraniectomy
Time Frame: Up to 14 days (average stay in the hospital)
Number of participants who required a decompressive hemicraniectomy in each group during initial hospitalization.
Up to 14 days (average stay in the hospital)
Intensive care unit (ICU) length-of-stay (LoS)
Time Frame: Up to 7 days (average stay in ICU)
Total number of days spent in ICU
Up to 7 days (average stay in ICU)
Duration of mechanical ventilation between groups
Time Frame: Up to 7 days (average ICU stay)
Duration that patients required mechanical ventilation
Up to 7 days (average ICU stay)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emory University

Collaborators

The Marcus Foundation

Investigators

  • Principal Investigator: Jonathan Ratcliff, MD, Emory University
  • Principal Investigator: Alex Hall, DHSc, Emory University
  • Principal Investigator: Gustavo Pradilla, MD, Emory University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 27, 2025

Primary Completion (Estimated)

March 1, 2030

Study Completion (Estimated)

March 1, 2030

Study Registration Dates

First Submitted

March 6, 2025

First Submitted That Met QC Criteria

March 6, 2025

First Posted (Actual)

March 11, 2025

Study Record Updates

Last Update Posted (Actual)

March 19, 2026

Last Update Submitted That Met QC Criteria

March 17, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00008310
  • 2025P011235 (Other Identifier: Emory Insight Humans IRB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The research team will share de-identified data upon reasonable request and approval by the Executive Committee no earlier than one year after the primary manuscript is published.

IPD Sharing Time Frame

Data will become available one year after the publication of the primary manuscript.

IPD Sharing Access Criteria

One year after the publication, academic institutions or industry researchers may submit requests to contribute to tertiary, meta, and other exploratory analyses and publications to the publications committee, provided they include a methodologically sound proposal. Proposals should be sent to REACHTRIAL@emory.edu. Data Transfer Agreements may be required.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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