~400 spots leftby Mar 2030

Surgical vs Medical Management for Intracerebral Hemorrhage

(REACH Trial)

Recruiting in Palo Alto (17 mi)
+2 other locations
Overseen byAlex Hall, DHSc
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: Emory University
No Placebo Group

Trial Summary

What is the purpose of this trial?

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 Criteria

This trial is for individuals who have experienced a deep hemorrhagic stroke, which is bleeding within the brain. Participants should not have had previous treatments that would affect the study's outcomes. The trial excludes those with conditions that may interfere with surgery or medical management, and those who are unlikely to follow the study protocol.

Inclusion Criteria

Glasgow Coma Score (GCS) 5 - 14
I am between 18 and 70 years old.
I had a specific type of brain bleed measured between 20-80 mL.
See 2 more

Exclusion Criteria

History of drug or alcohol use or dependence that would interfere with adherence to study requirements
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
See 19 more

Treatment Details

Interventions

  • Surgical management (Procedure)
Trial OverviewThe REACH trial is comparing two approaches: early minimally invasive surgery to remove blood from the brain versus standard medical care in ICU involving blood pressure control and other non-surgical methods aimed at preventing further bleeding or strokes.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Surgical management (MIPS) plus medical managementExperimental Treatment2 Interventions
Participants randomized to surgical management will follow the Medical Manual of the Clinical Standardization Guidelines (CSG) before and after surgery.
Group II: medical management.Active Control1 Intervention
Participants randomized to the medical management alone will be treated according to the Clinical Standardization Guidelines (CSG).

Find a Clinic Near You

Research Locations NearbySelect from list below to view details:
Emory University Hospital (EUH)Atlanta, GA
Grady Memorial HospitalAtlanta, GA
Emory Hospital MidtownAtlanta, GA
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Who Is Running the Clinical Trial?

Emory UniversityLead Sponsor
The Marcus FoundationCollaborator

References