Rapid Evacuation and Access of Cerebral Hemorrhage Trial

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура Surgical management
  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 tha
• Другое Medical Management
  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

Первичные конечные точки

• Score on the modified Rankin Scale (mRS) at [Срок оценки: 180 days after randomization]

Вторичные конечные точки (8)

• Hospital mortality [Срок оценки: Up to 14 days (average hospital stay)]
• All-cause mortality at discharge from the initial hospitalization [Срок оценки: 30 days after randomization]
• Change in hematoma volume [Срок оценки: Baseline and up to 36 hours post-randomization]
• Post-operative rebleeding associated with neurologic deterioration [Срок оценки: Up to 36 hours post-randomization]
• Serious adverse events [Срок оценки: 180-days post-randomization]
• Number of participants who required a decompressive hemicraniectomy [Срок оценки: Up to 14 days (average stay in the hospital)]
• Intensive care unit (ICU) length-of-stay (LoS) [Срок оценки: Up to 7 days (average stay in ICU)]
• Duration of mechanical ventilation between groups [Срок оценки: Up to 7 days (average ICU stay)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 21 центр

• University of Arkansas for Medical Sciences — Little Rock
• Stanford University Medical Center — Palo Alto
• Baptist Health Jacksonville FL — Jacksonville
• Baptist Health South Florida — Kendall
• Jackson Memorial Hospital (JMH) — Miami
• Grady Memorial Hospital — Atlanta
• Emory Hospital Midtown — Atlanta
• Emory University Hospital (EUH) — Atlanta
• … и ещё 13 центров

Идентификаторы

NCT: NCT06870812 · STUDY00008310 · 2025P011235

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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