Rapid Evacuation and Access of Cerebral Hemorrhage Trial
REACH
2 other identifiers
interventional
600
1 country
21
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2025
Longer than P75 for not_applicable
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 6, 2025
CompletedFirst Posted
Study publicly available on registry
March 11, 2025
CompletedStudy Start
First participant enrolled
May 27, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2030
March 19, 2026
March 1, 2026
4.8 years
March 6, 2025
March 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Score on the modified Rankin Scale (mRS) at
The mRS is a seven-level ordinal scale that ranges from 0 (no symptoms) to 6 (death).
180 days after randomization
Secondary Outcomes (8)
Hospital mortality
Up to 14 days (average hospital stay)
All-cause mortality at discharge from the initial hospitalization
30 days after randomization
Change in hematoma volume
Baseline and up to 36 hours post-randomization
Post-operative rebleeding associated with neurologic deterioration
Up to 36 hours post-randomization
Serious adverse events
180-days post-randomization
- +3 more secondary outcomes
Study Arms (2)
Surgical management (MIPS) plus medical management
EXPERIMENTALParticipants randomized to surgical management will follow the Medical Manual of the Clinical Standardization Guidelines (CSG) before and after surgery.
medical management.
ACTIVE COMPARATORParticipants randomized to the medical management alone will be treated according to the Clinical Standardization Guidelines (CSG).
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Emory Universitylead
- The Marcus Foundationcollaborator
Study Sites (21)
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alex Hall, DHSc
Emory University
- PRINCIPAL INVESTIGATOR
Gustavo Pradilla, MD
Emory University
- PRINCIPAL INVESTIGATOR
Jonathan Ratcliff, MD
Emory University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
March 6, 2025
First Posted
March 11, 2025
Study Start
May 27, 2025
Primary Completion (Estimated)
March 1, 2030
Study Completion (Estimated)
March 1, 2030
Last Updated
March 19, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ANALYTIC CODE
- Time Frame
- Data will become available one year after the publication of the primary manuscript.
- 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.
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.