Clinical trial NCT06870812: Rapid Evacuation and Access of Cerebral Hemorrhage Trial
Official title: Rapid Evacuation and Access of Cerebral Hemorrhage Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke Hemorrhagic
Keywords: Intracerebral hemorrhage
minimally invasive surgery
Blood clot
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: The Marcus Foundation
First posted: 2025-03-11
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Score on the modified Rankin Scale (mRS) at
timeFrame: 180 days after randomization
Secondary outcomes:
measure: Hospital mortality
timeFrame: Up to 14 days (average hospital stay)
measure: All-cause mortality at discharge from the initial hospitalization
timeFrame: 30 days after randomization
measure: Change in hematoma volume
timeFrame: Baseline and up to 36 hours post-randomization
measure: Post-operative rebleeding associated with neurologic deterioration
timeFrame: Up to 36 hours post-randomization
measure: Serious adverse events
timeFrame: 180-days post-randomization
measure: Number of participants who required a decompressive hemicraniectomy
timeFrame: Up to 14 days (average stay in the hospital)
measure: Intensive care unit (ICU) length-of-stay (LoS)
timeFrame: Up to 7 days (average stay in ICU)
measure: Duration of mechanical ventilation between groups
timeFrame: Up to 7 days (average ICU stay)
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Grady Memorial Hospital
state: Georgia
city: Atlanta
country: United States
facility: Emory Hospital Midtown
state: Georgia
city: Atlanta
country: United States
facility: Emory University Hospital (EUH)
state: Georgia
Study officials:
affiliation: Emory University
name: Alex Hall, DHSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory University
name: Gustavo Pradilla, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory University
name: Jonathan Ratcliff, MD
role: PRINCIPAL_INVESTIGATOR
References: