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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
600
Following randomization into the surgical arm, a competency-trained neurosurgeon will perform the MIPS for clot evacuation with strict adherence to the Surgical Manual of the CSG. Image interpretation, patient position, anesthetic plan, stereotactic navigation registration, exoscopic positioning, access, optics, resection, and hemostasis are detailed in the Surgical Manual of the CSG. The OR arrival time should occur \<24 hours from the last known normal (LKN) with a goal of arrival in less than 8 hours from the last known normal.
Following randomization into the medical arm patients will be treated following the Medical Manual of the CSG. The Medical Manual has been adapted by the REACH Executive Committee (REC) from the current American Heart Association (AHA) and American Stroke Association (ASA) Guidelines for the Management of Spontaneous Intracerebral Hemorrhage. Whenever clinically feasible, the CSG should be followed as it represents a template for the care of these subjects. The Medical Manual details specialty level of care, including intensive care placement, blood pressure control, hemostasis and coagulopathy, anemia, deep venous thrombosis and pulmonary embolism prophylaxis/treatment, glucose management, temperature management, seizure prophylaxis, intracranial pressure monitoring and management, intraventricular hemorrhage (IVH)/obstructive hydrocephalus management, cerebral edema, decompressive hemicraniectomy, nutritional support, respiratory support, and comfort care.
Baptist Health Jacksonville FL
Jacksonville, Florida, United States
RECRUITINGGrady Memorial Hospital
Atlanta, Georgia, United States
RECRUITINGEmory Hospital Midtown
Atlanta, Georgia, United States
RECRUITINGEmory University Hospital (EUH)
Atlanta, Georgia, United States
RECRUITINGRush University
Chicago, Illinois, United States
NOT_YET_RECRUITINGEndeavor Health, Northshore
Evanston, Illinois, United States
NOT_YET_RECRUITINGSUNY Upstate Medical University
Syracuse, New York, United States
NOT_YET_RECRUITINGScore on the modified Rankin Scale (mRS) at
The mRS is a seven-level ordinal scale that ranges from 0 (no symptoms) to 6 (death).
Time frame: 180 days after randomization
Hospital mortality
Mortality rate during hospitalization will be calculated.
Time frame: Up to 14 days (average hospital stay)
All-cause mortality at discharge from the initial hospitalization
All-cause mortality rate will be calculated.
Time frame: 30 days after randomization
Change in hematoma volume
The change in hematoma volume from the initial to the follow-up neuroimaging for surgical management versus medical management.
Time frame: Baseline and up to 36 hours post-randomization
Post-operative rebleeding associated with neurologic deterioration
Post-operative rebleeding associated with neurologic deterioration (defined as a growth in hematoma volume between the initial CT and follow-up neuroimaging and an increase of 4 or more points on the NIH stroke scale or a decrease of up to 2 points on the GCS that was not explained by planned medical interventions \[e.g., sedatives, analgesics, and procedures\]). \*This outcome applies to the surgery group only.
Time frame: Up to 36 hours post-randomization
Serious adverse events
All adverse events will be recorded f after randomization until the final follow-up visit.
Time frame: 180-days post-randomization
Number of participants who required a decompressive hemicraniectomy
Number of participants who required a decompressive hemicraniectomy in each group during initial hospitalization.
Time frame: Up to 14 days (average stay in the hospital)
Intensive care unit (ICU) length-of-stay (LoS)
Total number of days spent in ICU
Time frame: Up to 7 days (average stay in ICU)
Duration of mechanical ventilation between groups
Duration that patients required mechanical ventilation
Time frame: Up to 7 days (average ICU stay)
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