Rapid Evacuation and Access of Cerebral Hemorrhage Trial
NCT ID: NCT06870812
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
600 participants
INTERVENTIONAL
2025-05-27
2030-03-31
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
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.
medical management.
Participants randomized to the medical management alone will be treated according to the Clinical Standardization Guidelines (CSG).
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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The Marcus Foundation
OTHER
Emory University
OTHER
Responsible Party
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Alex Hall
Assistant Professor
Principal Investigators
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Alex Hall, DHSc
Role: PRINCIPAL_INVESTIGATOR
Emory University
Gustavo Pradilla, MD
Role: PRINCIPAL_INVESTIGATOR
Emory University
Jonathan Ratcliff, MD
Role: PRINCIPAL_INVESTIGATOR
Emory University
Locations
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Baptist Health Jacksonville FL
Jacksonville, Florida, United States
Grady Memorial Hospital
Atlanta, Georgia, United States
Emory Hospital Midtown
Atlanta, Georgia, United States
Emory University Hospital (EUH)
Atlanta, Georgia, United States
Rush University
Chicago, Illinois, United States
Endeavor Health, Northshore
Evanston, Illinois, United States
SUNY Upstate Medical University
Syracuse, New York, United States
Countries
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Central Contacts
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Facility Contacts
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Dollie Jennings, Ph.D.
Role: primary
Garet Michael, MBA, MPH
Role: primary
Garet Michael, MBA, MPH
Role: primary
Connor McMillan, BS
Role: primary
Morgan Roll, SW
Role: primary
Boris Jancan, MD, CCRP
Role: primary
Lena Deb
Role: primary
Other Identifiers
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2025P011235
Identifier Type: OTHER
Identifier Source: secondary_id
STUDY00008310
Identifier Type: -
Identifier Source: org_study_id