Rapid Evacuation and Access of Cerebral Hemorrhage Trial
Purpose
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.
Condition
- Stroke Hemorrhagic
Eligibility
- Eligible Ages
- Between 18 Years and 70 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
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 (less than 1 year) ICH, as diagnosed with radiographic imaging - 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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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). |
|
Recruiting Locations
Jacksonville, Florida 32207
Atlanta, Georgia 30303
Atlanta, Georgia 30308
Atlanta, Georgia 30322
Evanston, Illinois 60201
Syracuse, New York 13210
Toledo, Ohio 43606
Providence, Rhode Island 02912
More Details
- NCT ID
- NCT06870812
- Status
- Recruiting
- Sponsor
- Emory University
Detailed Description
The REACH trial, which stands for Rapid Evacuation and Access of Cerebral Hemorrhage Trial, is a medical research study aimed at finding better ways to treat people who have had a specific type of stroke called an intracerebral hemorrhage. This type of stroke happens when a blood vessel bursts and causes bleeding in the brain. 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.