Rapid Evacuation and Access of Cerebral Hemorrhage Trial

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Other, Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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

Locations
United States
Georgia
Emory Hospital Midtown
RECRUITING
Atlanta
Emory University Hospital (EUH)
RECRUITING
Atlanta
Grady Memorial Hospital
RECRUITING
Atlanta
Contact Information
Primary
Alex Hall, DHSc
alex.hall@emory.edu
404-778-1585
Time Frame
Start Date: 2025-05-27
Estimated Completion Date: 2030-03
Participants
Target number of participants: 600
Treatments
Experimental: 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.
Active_comparator: medical management.
Participants randomized to the medical management alone will be treated according to the Clinical Standardization Guidelines (CSG).
Sponsors
Collaborators: The Marcus Foundation
Leads: Emory University

This content was sourced from clinicaltrials.gov