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Stroke HemorrhagicREACHNCT06870812

Rapid Evacuation and Access of Cerebral Hemorrhage Trial

A study testing Surgical management and Medical Management in people with Stroke Hemorrhagic, run by Emory University at 24 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Stroke Hemorrhagic
What is being tested?
Surgical management and Medical Management
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
600 participants
Where
24 sitesUnited States
Study dates
27 May 2025to Mar 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 22Show fewer
  • 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

Trial locations and contacts

24 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Alex Hall, DHSc contact

404-778-1585

alex.hall@emory.edu

24 sites in 1 country

United States24 sites, 24 recruiting

  • Albany Medical Center

    Albany, New York, 12208

    Chelsey Large, largec@amc.edu

    Alexandra Paul, MD

    Recruiting

  • Grady Memorial Hospital

    Atlanta, Georgia, 30303

    Garet Michael, MBA, MPH, 404.778.1711, Garett.michael@emory.edu

    Aqueel Pabaney, MD

    Recruiting

  • Emory Hospital Midtown

    Atlanta, Georgia, 30308

    Garet Michael, MBA, MPH, 404.778.1711, Garett.michael@emory.edu

    Tomas Garzon-Muvdi, MD

    Recruiting

  • Emory University Hospital (EUH)

    Atlanta, Georgia, 30322

    Connor McMillan, BS, 404-727-1337, connor.mcmillan@emory.edu

    Brian Howard, MD

    Recruiting

  • Johns Hopkins School of Medicine

    Baltimore, Maryland, 21287

    Whitney Isennock, wwebb10@jh.edu

    Justin Caplan, MD

    Recruiting

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

    Jessica Schweikart, jlschweikart@uabmc.edu

    Philip G Schmalz, MD

    Not yet recruiting

  • RUSH University Medical Center

    Chicago, Illinois, 60612

    Reehan Malhance, Reehan_T_Malhance@rush.edu

    Richard Crowley, MD

    Not yet recruiting

  • University of Missouri

    Columbia, Missouri, 65212

    Brooke Hoffman, hoffmanba@health.missouri.edu

    Michael Chicoine, MD

    Recruiting

  • Ohio State University

    Columbus, Ohio, 43210

    Edouard Belizaire, edouard.belizaire@osumc.edu

    Patrick Youssef, MD

    Not yet recruiting

  • Endeavor Health, Northshore

    Evanston, Illinois, 60201

    Boris Jancan, MD, CCRP, 847-570-3674, bjancan@northshore.org

    Shakeel Chowdhry, MD

    Recruiting

  • Penn State Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033

    Erin King, eking9@pennstatehealth.psu.edu

    Ephraim Church, MD

    Not yet recruiting

  • St Vincent Hospital/Goodman Campbell Brain and Spine

    Indianapolis, Indiana, 46260

    Luke Watkins, RN, BSN, CCRP, 317-565-3572, lwatkins@goodmancampbell.com

    Charles Kulwin, MD

    Recruiting

  • Baptist Health Jacksonville FL

    Jacksonville, Florida, 32207

    Dollie Jennings, Ph.D., 904-202-7063, Sarah.jennings@bmc.edu

    Ricardo Hanel, MD, PhD

    Recruiting

  • Baptist Health South Florida

    Kendall, Florida, 33176

    Marianela A Cruz, marianela.cruz@baptisthealth.net

    Sukie Hernandez, Sukie.Hernandez@baptisthealth.net

    Recruiting

  • University of Kentucky Health Care, Kentucky Neuroscience Institute

    Lexington, Kentucky, 40536

    Rachel Norris, rachel.norris@uky.edu

    David Dornbos, MD

    Recruiting

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

    Kennetha Newman, NewmanKennethaL@uams.edu

    Deanna Sasaki-Adams, MD

    Recruiting

  • University of Miami Health System, Jackson Memorial Hospital

    Miami, Florida, 33125

    Ahmed Abdelsalam, aaa824@med.miami.edu

    Robert Starke, MD

    Recruiting

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

    Anna Bican, anna.bican@vumc.org

    Matthew Fusco, MD

    Recruiting

  • Stanford University Medical Center

    Palo Alto, California, 94304

    Bharati Sanjawala, bharatis@stanford.edu

    Robert Dodd, MD

    Not yet recruiting

  • Advocate Aurora Research Institute

    Park Ridge, Illinois, 60068

    Demetrius Lopes, MD, (847) 723-2078, Demetrius.Lopes@advocatehealth.com

    Miharsh Patel, Miharsh.Patel@aah.org

    Not yet recruiting

  • Rhode Island Hospital/Brown University Health

    Providence, Rhode Island, 02912

    Mei Tiemeyer, mtiemeyer@brownhealth.org

    Krisztina Moldovan, MD

    Recruiting

  • SUNY Upstate Medical University

    Syracuse, New York, 13210

    Lena Deb, 315-464-9756, DebL@upstate.edu

    Timothy Beutler, MD, FAANS

    Recruiting

  • Montefiore Medical Center/Albert Einstein School of Medicine

    The Bronx, New York, 10467

    Lavinia Williams, lavwilliam@montefiore.org

    David Altschful, MS

    Not yet recruiting

  • ProMedica Toledo Hospital

    Toledo, Ohio, 43606

    Melanie Pakulski, melanie.pakulski@promedica.org

    Kevin Reinard, MD

    Recruiting

Other trials in United States

About this study

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.

Read the 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.

Being tested
Surgical management, Medical Management
Keywords
Intracerebral hemorrhage, minimally invasive surgery, Blood clot
Medical subject headings
Hemorrhagic Stroke, Cerebral Hemorrhage, Thrombosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Surgical managementProcedure or surgery

    Also called Early minimally invasive parafascicular surgery (MIPS)

    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 ManagementOther

    Also called Standard of Care (SOC)

    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.

Study groups in NCT06870812
Study groupRoleWhat they receive
Surgical management (MIPS) plus medical managementExperimentalParticipants randomized to surgical management will follow the Medical Manual of the Clinical Standardization Guidelines (CSG) before and after surgery.
Receives: Procedure: Surgical management; Other: Medical Management
medical management.Active comparatorParticipants randomized to the medical management alone will be treated according to the Clinical Standardization Guidelines (CSG).
Receives: Other: Medical Management

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 180 days after randomization

Secondary outcomes (8)

  1. Hospital mortality

    Mortality rate during hospitalization will be calculated.

    Measured: Up to 14 days (average hospital stay)

  2. All-cause mortality at discharge from the initial hospitalization

    All-cause mortality rate will be calculated.

    Measured: 30 days after randomization

  3. Change in hematoma volume

    The change in hematoma volume from the initial to the follow-up neuroimaging for surgical management versus medical management.

    Measured: Baseline and up to 36 hours post-randomization

  4. Post-operative rebleeding associated with neurologic deterioration

    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.

    Measured: Up to 36 hours post-randomization

  5. Serious adverse events

    All adverse events will be recorded f after randomization until the final follow-up visit.

    Measured: 180-days post-randomization

  6. Number of participants who required a decompressive hemicraniectomy

    Number of participants who required a decompressive hemicraniectomy in each group during initial hospitalization.

    Measured: Up to 14 days (average stay in the hospital)

  7. Intensive care unit (ICU) length-of-stay (LoS)

    Total number of days spent in ICU

    Measured: Up to 7 days (average stay in ICU)

  8. Duration of mechanical ventilation between groups

    Duration that patients required mechanical ventilation

    Measured: Up to 7 days (average ICU stay)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Mar 2025
  2. Study start27 May 2025
  3. Primary completionMar 2030 (estimated)
  4. Study completionMar 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06870812
Sponsor's protocol ID
STUDY00008310
Other IDs
2025P011235
Acronym
REACH
Status last verified
Aug 2026
First submitted
6 Mar 2025
Last updated
14 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A study testing Surgical management and Medical Management in people with Stroke Hemorrhagic, run by Emory University at 24 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Alex Hall, DHSc (404-778-1585, alex.hall@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Score on the modified Rankin Scale (mRS) at (time frame: 180 days after randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06870812.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.

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