Rapid Evacuation and Access of Cerebral Hemorrhage Registry (REACH)

Emory University

Status: Not yet enrolling

Conditions: Intracerebral Hemorrhage

Study type: Observational

Funder types: Other

Identifiers

NCT07651631

2026P000373

Details and patient eligibility

About

The goal of this observational study is to quantify the real-world effect of minimally invasive surgery (MIS) in patients with acute spontaneous supratentorial intracerebral hemorrhage.

Full description

Intracerebral hemorrhage (ICH) is one of the most severe forms of stroke, accounting for nearly one-third of all strokes worldwide and affecting more than 3 million people annually. It remains associated with high mortality-over 40% of patients die within 30 days-and significant long-term disability among survivors. Basal ganglia hemorrhage is the most common location of spontaneous ICH and often results in profound neurological deficits, including weakness, sensory loss, visual impairment, and cognitive or speech difficulties. In the United States, more than 80,000 patients each year experience an acute ICH, and the condition contributes substantially to years of life lost, particularly among adults aged 35-65.

Despite decades of research, treatment options for ICH remain limited. Standard medical management focuses on blood pressure control, reversal of coagulopathy, prevention of hematoma expansion, and management of intracranial pressure. Traditional open craniotomy has not consistently improved functional outcomes and carries risks such as infection, rebleeding, and prolonged recovery. As a result, interest has grown in minimally invasive surgical (MIS) techniques designed to remove the hematoma while minimizing damage to surrounding brain tissue.

Over the past two decades, several MIS approaches have been developed, including catheter-based aspiration with thrombolytics, neuroendoscopic evacuation, minimally invasive puncture and drainage, and navigated trans-sulcal parafascicular surgery using tubular retractors. These techniques aim to reduce surgical trauma, improve hematoma evacuation, and limit secondary brain injury caused by inflammation, oxidative stress, and perihematomal edema.

Recent randomized trials have provided important insights into the potential benefits of MIS. The MISTIE III trial demonstrated procedural safety and suggested improved outcomes in patients who achieved substantial hematoma reduction. The ENRICH trial showed that early minimally invasive parafascicular surgery improved functional outcomes at 180 days for patients with lobar ICH and reduced mortality, ICU stay, and serious adverse events. Other trials, including MIND and SWITCH, have contributed additional data on safety, short-term disability, and the potential role of MIS in deep hemorrhages. Updated guidelines from the European Stroke Organization and the American Heart Association now support consideration of MIS for selected patients with supratentorial ICH.

Although evidence is growing, real-world practice varies widely due to differences in patient selection, surgical expertise, device availability, and institutional protocols. Randomized trials often include highly selected populations, limiting generalizability. There is a need for large-scale, prospective, real-world data to better understand how MIS is used across diverse clinical settings and to identify which patients benefit most.

The Rapid Evacuation and Access of Cerebral Hemorrhage (REACH) Registry is designed to address these gaps by prospectively collecting standardized data on patients undergoing MIS evacuation for spontaneous supratentorial ICH. The registry will capture patient demographics, comorbidities, hematoma characteristics, surgical techniques, timing of intervention, degree of hematoma evacuation, and clinical outcomes including mortality, complications, and functional status. By aggregating real-world data across multiple centers, the registry aims to evaluate the safety and effectiveness of different MIS approaches, identify predictors of favorable recovery, and support ongoing improvements in clinical practice.

Ultimately, the REACH Registry seeks to advance evidence-based care for patients with ICH, inform future clinical trials, and contribute to the refinement of national and international treatment guidelines

Enrollment: 2,500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Head CT demonstrating an acute, spontaneous, intracerebral hemorrhage
• Hemorrhage volume ≥ 20 mLs
• Minimally invasive surgical intervention performed within 7 days of hemorrhage

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 ICH (<1 year), as diagnosed with radiographic imaging
• Infratentorial intraparenchymal hemorrhage, including midbrain, pontine, or cerebellum
• Initial hospital arrival ≥ 24 hours after the onset of stroke symptoms
• Last known normal is unknown
• Historical Modified Rankin Score > 4
• Known life-expectancy of less than 1 year prior to ICH
• DNR or comfort measures only
• Known pregnancy in female subjects
• Inability or unwillingness of subject or legal guardian/representative to give written informed consent within 7 days of initial hospital arrival
• Inability to meet follow up requiremen

Trial design

2,500 participants in 2 patient groups

Minimally Invasive Surgical Groups

Description:

* Surgical A: Endport evacuation (i.e., MIPS via BrainPath or similar device) * Surgical B: Endoscopic evacuation * Surgical C: Catheter-based evacuation * Surgical D: Other minimally invasive surgical techniques involving clot evacuation

Control Group

Description:

No minimally invasive surgical hematoma evacuation performed; n=300 total, capped across 20 sites; may include patients undergoing decompressive hemicraniectomy or other standard medical/surgical approaches): * Basal Ganglia Controls (\>50% IVH or ICH volume ≥80 mL; n=100) * Lobar Controls (ICH volume ≥80 mL; n=100) * Primary Thalamic Controls (n=100) * ENRICH Trial Controls (ABG and lobar locations; n=150) * REACH Trial Controls (ABG location; n=maximum 300)