Rapid Evacuation and Access of Cerebral Hemorrhage Registry (REACH)

A Prospective, Multicenter, Global Registry Evaluating Minimally Invasive Surgery for the Treatment of Acute Spontaneous Supratentorial Intracerebral Hemorrhage.

The goal of this observational study is to quantify the real-world effect of minimally invasive surgery (MIS) in patients with acute spontaneous supratentorial intracerebral hemorrhage.

Study Overview

• Status: Not yet recruiting
• Conditions: Intracerebral Hemorrhage

Detailed Description

Intracerebral hemorrhage (ICH) is one of the most severe forms of stroke, accounting for nearly one-third of all strokes worldwide and affecting more than 3 million people annually. It remains associated with high mortality-over 40% of patients die within 30 days-and significant long-term disability among survivors. Basal ganglia hemorrhage is the most common location of spontaneous ICH and often results in profound neurological deficits, including weakness, sensory loss, visual impairment, and cognitive or speech difficulties. In the United States, more than 80,000 patients each year experience an acute ICH, and the condition contributes substantially to years of life lost, particularly among adults aged 35-65.

Despite decades of research, treatment options for ICH remain limited. Standard medical management focuses on blood pressure control, reversal of coagulopathy, prevention of hematoma expansion, and management of intracranial pressure. Traditional open craniotomy has not consistently improved functional outcomes and carries risks such as infection, rebleeding, and prolonged recovery. As a result, interest has grown in minimally invasive surgical (MIS) techniques designed to remove the hematoma while minimizing damage to surrounding brain tissue.

Over the past two decades, several MIS approaches have been developed, including catheter-based aspiration with thrombolytics, neuroendoscopic evacuation, minimally invasive puncture and drainage, and navigated trans-sulcal parafascicular surgery using tubular retractors. These techniques aim to reduce surgical trauma, improve hematoma evacuation, and limit secondary brain injury caused by inflammation, oxidative stress, and perihematomal edema.

Recent randomized trials have provided important insights into the potential benefits of MIS. The MISTIE III trial demonstrated procedural safety and suggested improved outcomes in patients who achieved substantial hematoma reduction. The ENRICH trial showed that early minimally invasive parafascicular surgery improved functional outcomes at 180 days for patients with lobar ICH and reduced mortality, ICU stay, and serious adverse events. Other trials, including MIND and SWITCH, have contributed additional data on safety, short-term disability, and the potential role of MIS in deep hemorrhages. Updated guidelines from the European Stroke Organization and the American Heart Association now support consideration of MIS for selected patients with supratentorial ICH.

Although evidence is growing, real-world practice varies widely due to differences in patient selection, surgical expertise, device availability, and institutional protocols. Randomized trials often include highly selected populations, limiting generalizability. There is a need for large-scale, prospective, real-world data to better understand how MIS is used across diverse clinical settings and to identify which patients benefit most.

The Rapid Evacuation and Access of Cerebral Hemorrhage (REACH) Registry is designed to address these gaps by prospectively collecting standardized data on patients undergoing MIS evacuation for spontaneous supratentorial ICH. The registry will capture patient demographics, comorbidities, hematoma characteristics, surgical techniques, timing of intervention, degree of hematoma evacuation, and clinical outcomes including mortality, complications, and functional status. By aggregating real-world data across multiple centers, the registry aims to evaluate the safety and effectiveness of different MIS approaches, identify predictors of favorable recovery, and support ongoing improvements in clinical practice.

Ultimately, the REACH Registry seeks to advance evidence-based care for patients with ICH, inform future clinical trials, and contribute to the refinement of national and international treatment guidelines

• Study Type: Observational
• Enrollment (Estimated): 2500

Contacts and Locations

• Study Contact: Name: Alex Hall, DHSc; Phone Number: 404-778-1585; Email: alex.hall@emory.edu

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30303
      • Grady Memorial Hospital
      • Principal Investigator: Jonathan Ratcliff, MD, MPH
      • Contact: Alex Hall, DHSc, MS
      • Principal Investigator: Alex Hall, DHSc, MS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Subjects with acute, spontaneous supratentorial intracerebral hemorrhage.

Description

Inclusion Criteria:

• Head CT demonstrating an acute, spontaneous, intracerebral hemorrhage
• Hemorrhage volume ≥ 20 mLs
• Minimally invasive surgical intervention performed within 7 days of hemorrhage

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 ICH (<1 year), as diagnosed with radiographic imaging
• Infratentorial intraparenchymal hemorrhage, including midbrain, pontine, or cerebellum
• Initial hospital arrival ≥ 24 hours after the onset of stroke symptoms
• Last known normal is unknown
• Historical Modified Rankin Score > 4
• Known life-expectancy of less than 1 year prior to ICH
• DNR or comfort measures only
• Known pregnancy in female subjects
• Inability or unwillingness of subject or legal guardian/representative to give written informed consent within 7 days of initial hospital arrival
• Inability to meet follow up requiremen

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Minimally Invasive Surgical Groups; Surgical A: Endport evacuation (i.e., MIPS via BrainPath or similar device); Surgical B: Endoscopic evacuation; Surgical C: Catheter-based evacuation; Surgical D: Other minimally invasive surgical techniques involving clot evacuation
Control Group; No minimally invasive surgical hematoma evacuation performed; n=300 total, capped across 20 sites; may include patients undergoing decompressive hemicraniectomy or other standard medical/surgical approaches): Basal Ganglia Controls (>50% IVH or ICH volume ≥80 mL; n=100); Lobar Controls (ICH volume ≥80 mL; n=100); Primary Thalamic Controls (n=100); ENRICH Trial Controls (ABG and lobar locations; n=150); REACH Trial Controls (ABG location; n=maximum 300)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Rankin Scale (mRS) at 180 Days	Functional outcome will be assessed using the modified Rankin Scale (mRS), a 7-level ordinal scale ranging from 0 (no symptoms) to 6 (death). The primary endpoint evaluates real-world functional recovery following minimally invasive surgery (MIS) for acute supratentorial ICH. Structured interview performed in person or via telephone by trained study personnel; audio-recorded and centrally adjudicated.	Day 180 from baseline (±14 days)
30-Day Mortality	All-cause mortality within 30 days of the initial hemorrhage.	Day 30 (±7 days)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
modified Rankin Scale (mRS) at Additional Time Points	The endpoint evaluates real-world functional recovery following minimally invasive surgery (MIS) for acute supratentorial ICH. Collected over phone or in-person via structured interview.	Day 7, 30, 90, 180, 365
Post-Operative Infection or CSF Leak	Incidence of surgical site infection or cerebrospinal fluid leak.	Baseline through Day 365
Quality of Life (EQ-5D-5L)	The EQ-5D-5L assesses health status across five dimensions: Mobility; Self-care; Usual activities; Pain/discomfort; Anxiety/depression Each dimension has five levels (no problems, slight problems, moderate problems, severe problems, extreme problems), allowing patients to describe their health using a five-digit health state (e.g., 11223). Patients also complete a Visual Analogue Scale (VAS) rating their overall health from 0 (worst imaginable) to 100 (best imaginable)	Day 7, 30, 90, 180, 365
Follow-Up Neuroimaging (24-Hour)	Assessment of hematoma evacuation effectiveness and residual volume.	Within 24 hours post-procedure
In-Hospital Mortality	All-cause mortality occurring during the initial hospitalization.	From date of enrollment through the date of hospital discharge (upto 14 days)
Change in Hematoma Volume	Difference between initial hematoma volume and follow-up neuroimaging volume, assessed centrally by the Neuroimaging Core Lab.	Baseline to follow-up imaging (within first 10 days)
Post-Operative Rebleeding With Neurologic Deterioration (Surgery Group Only)	Rebleeding is defined as hematoma growth on follow-up imaging accompanied by neurologic decline (National Institute of Health Stroke Scale (NIHSS) increase ≥4 or Glasgow Coma Score (GCS) decrease ≤2)	Baseline through Day 10
Time to Intervention	Time from ictus (symptom onset) to MIS procedure.	From time of enrollment through the time of procedure (upto 100 days)
Surgical Complications	Any intraoperative or postoperative complication related to Minimally invasive surgery (MIS) technique, including device-related events.	Baseline through Day 365
Residual Post-Operative Hemorrhage Volume	Quantification of remaining hematoma volume after MIS.	Post-operative imaging (≤10 days)
Serious Adverse Events (SAEs)	SAEs include events resulting in death, life-threatening conditions, hospitalization, disability, or events requiring medical/surgical intervention.	Baseline through Day 365
Hospital Length of Stay	Total number of days from hospital admission to discharge.	From date of enrollment to the date of discharge (upto 4 weeks or more)
Decompressive Hemicraniectomy	Receipt of decompressive hemicraniectomy during the initial hospitalization.	Baseline through discharge (upto 100 days or more)
ICU Length of Stay	Number of days from ICU admission to ICU discharge.	From date of enrollment to the date of ICU discharge (upto 100 days or more)
Duration of Mechanical Ventilation	Total duration of mechanical ventilation during the initial hospitalization.	Time from enrollment to the time mechanical ventilation was stopped (upto 100 days or more)

Collaborators and Investigators

• Sponsor: Emory University
• Collaborators: The Marcus Foundation
• Investigators: Principal Investigator: Alex Hall, DHSc, Emory University; Principal Investigator: Gustavo Pradilla, MD, Emory University; Principal Investigator: Jonathan Ratcliff,, MD, MPH, Emory University

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2033
• Study Completion (Estimated): June 1, 2033

Study Registration Dates

• First Submitted: May 23, 2026
• First Submitted That Met QC Criteria: June 11, 2026
• First Posted (Actual): June 16, 2026

Study Record Updates

• Last Update Posted (Actual): June 16, 2026
• Last Update Submitted That Met QC Criteria: June 11, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: modified Rankin Scale; Arteriovenous Malformation; Intracerebral Hemorrhage; ICH is the basal ganglia
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Hemorrhage; Congenital Abnormalities; Cardiovascular Abnormalities; Intracranial Hemorrhages; Vascular Malformations; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Cerebral Hemorrhage; Arteriovenous Malformations
• Other Study ID Numbers: 2026P000373

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be shared for special requests. REACH Trial must have the primary paper published, and the first 3 papers from the registry must be complete before the data becomes available for sharing.
• IPD Sharing Access Criteria: Request to REACH Registry Executive Committee and/or REACH Registry Publications and Data Management Committee (PDMC)
• 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