Rapid Evacuation and Access of Cerebral Hemorrhage Registry

NCT07651631 | Not Yet Recruiting DMC

• 1 other identifier: 2026P000373
• Study Type: observational
• Target: 2,500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Intracerebral Hemorrhage

Keywords

Intracerebral Hemorrhage; ICH is the basal ganglia; modified Rankin Scale; Arteriovenous Malformation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (15)

• modified Rankin Scale (mRS) at Additional Time Points

  Day 7, 30, 90, 180, 365

• Post-Operative Infection or CSF Leak

  Baseline through Day 365

• Quality of Life (EQ-5D-5L)

  Day 7, 30, 90, 180, 365

Study Arms (2)

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects with acute, spontaneous supratentorial intracerebral hemorrhage.

You may qualify if:

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

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 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

Sponsors & Collaborators

• Emory University: lead
• The Marcus Foundation: collaborator

Study Sites (1)

Grady Memorial Hospital

Atlanta, Georgia, 30303, United States

Location

MeSH Terms

Conditions

Cerebral Hemorrhage; Arteriovenous Malformations

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Malformations; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Alex Hall, DHSc

  Emory University

  PRINCIPAL INVESTIGATOR

• Gustavo Pradilla, MD

  Emory University

  PRINCIPAL INVESTIGATOR

• Jonathan Ratcliff,, MD, MPH

  Emory University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alex Hall, DHSc

CONTACT

404-778-1585; alex.hall@emory.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 23, 2026
• First Posted: June 16, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2033
• Study Completion (Estimated): June 1, 2033
• Last Updated: June 16, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Access Criteria: Request to REACH Registry Executive Committee and/or REACH Registry Publications and Data Management Committee (PDMC)

Locations

US (1)