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NCT Number: NCT07651631

Rapid Evacuation and Access of Cerebral Hemorrhage Registry

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Grady Memorial Hospital

Atlanta, Georgia, 30303, United States

Location contact

Alex Hall, DHSc, MS

CONTACT

Alex Hall, DHSc, MS

PRINCIPAL_INVESTIGATOR

Jonathan Ratcliff, MD, MPH

PRINCIPAL_INVESTIGATOR

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Modified Rankin Scale (mRS) at 180 Days

    Time frame: Day 180 from baseline (±14 days)

    Functional outcome will be assessed using the modified Rankin Scale (mRS), a 7-level ordinal scale ranging from 0 (no symptoms) to 6 (death). The primary endpoint evaluates real-world functional recovery following minimally invasive surgery (MIS) for acute supratentorial ICH.

    Structured interview performed in person or via telephone by trained study personnel; audio-recorded and centrally adjudicated.

  2. 30-Day Mortality

    Time frame: Day 30 (±7 days)

    All-cause mortality within 30 days of the initial hemorrhage.

Other outcomes

  1. modified Rankin Scale (mRS) at Additional Time Points

    Time frame: Day 7, 30, 90, 180, 365

    The endpoint evaluates real-world functional recovery following minimally invasive surgery (MIS) for acute supratentorial ICH. Collected over phone or in-person via structured interview.

  2. Post-Operative Infection or CSF Leak

    Time frame: Baseline through Day 365

    Incidence of surgical site infection or cerebrospinal fluid leak.

  3. Quality of Life (EQ-5D-5L)

    Time frame: Day 7, 30, 90, 180, 365

    The EQ-5D-5L assesses health status across five dimensions:

    • Mobility
    • Self-care
    • Usual activities
    • Pain/discomfort
    • Anxiety/depression

    Each dimension has five levels (no problems, slight problems, moderate problems, severe problems, extreme problems), allowing patients to describe their health using a five-digit health state (e.g., 11223).

    Patients also complete a Visual Analogue Scale (VAS) rating their overall health from 0 (worst imaginable) to 100 (best imaginable)

  4. Follow-Up Neuroimaging (24-Hour)

    Time frame: Within 24 hours post-procedure

    Assessment of hematoma evacuation effectiveness and residual volume.

  5. In-Hospital Mortality

    Time frame: From date of enrollment through the date of hospital discharge (upto 14 days)

    All-cause mortality occurring during the initial hospitalization.

  6. Change in Hematoma Volume

    Time frame: Baseline to follow-up imaging (within first 10 days)

    Difference between initial hematoma volume and follow-up neuroimaging volume, assessed centrally by the Neuroimaging Core Lab.

  7. Post-Operative Rebleeding With Neurologic Deterioration (Surgery Group Only)

    Time frame: Baseline through Day 10

    Rebleeding is defined as hematoma growth on follow-up imaging accompanied by neurologic decline (National Institute of Health Stroke Scale (NIHSS) increase ≥4 or Glasgow Coma Score (GCS) decrease ≤2)

  8. Time to Intervention

    Time frame: From time of enrollment through the time of procedure (upto 100 days)

    Time from ictus (symptom onset) to MIS procedure.

  9. Surgical Complications

    Time frame: Baseline through Day 365

    Any intraoperative or postoperative complication related to Minimally invasive surgery (MIS) technique, including device-related events.

  10. Residual Post-Operative Hemorrhage Volume

    Time frame: Post-operative imaging (≤10 days)

    Quantification of remaining hematoma volume after MIS.

  11. Serious Adverse Events (SAEs)

    Time frame: Baseline through Day 365

    SAEs include events resulting in death, life-threatening conditions, hospitalization, disability, or events requiring medical/surgical intervention.

  12. Hospital Length of Stay

    Time frame: From date of enrollment to the date of discharge (upto 4 weeks or more)

    Total number of days from hospital admission to discharge.

  13. Decompressive Hemicraniectomy

    Time frame: Baseline through discharge (upto 100 days or more)

    Receipt of decompressive hemicraniectomy during the initial hospitalization.

  14. ICU Length of Stay

    Time frame: From date of enrollment to the date of ICU discharge (upto 100 days or more)

    Number of days from ICU admission to ICU discharge.

  15. Duration of Mechanical Ventilation

    Time frame: Time from enrollment to the time mechanical ventilation was stopped (upto 100 days or more)

    Total duration of mechanical ventilation during the initial hospitalization.

Study contacts

Contact information is provided by the study sponsor or research team.

Alex Hall, DHSc

CONTACT

[email protected]

404-778-1585

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • The Marcus Foundation

Registry information

Official study title

A Prospective, Multicenter, Global Registry Evaluating Minimally Invasive Surgery for the Treatment of Acute Spontaneous Supratentorial Intracerebral Hemorrhage.

Acronym: REACH

Important dates

Study start
2026
Primary completion
2033
Study completion
2033
First posted
Jun 16, 2026
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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