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Rapid Evacuation and Access of Cerebral Hemorrhage Trial

ConditionStroke Hemorrhagic
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorEmory University

About 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 does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Surgical management

    Procedure/Surgery

    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.

  • Medical Management

    Other intervention

    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.

Treatment groups

600 Participants
are divided into 2 treatment groups
Group A: Surgical management (MIPS) plus medical managementExperimental treatment 2 interventions
Group B: medical management.Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Score 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

Secondary outcomes

1

Hospital mortality

Mortality rate during hospitalization will be calculated.

Time frame
Up to 14 days (average hospital stay)
2

All-cause mortality at discharge from the initial hospitalization

All-cause mortality rate will be calculated.

Time frame
30 days after randomization
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Emory University

Lead sponsor

The Marcus Foundation

Collaborator

Source ClinicalTrials.gov
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