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Rapid Evacuation and Access of Cerebral Hemorrhage Registry (REACH)

11 giugno 2026 aggiornato da: Alex Hall, Emory University

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

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.

Panoramica dello studio

Stato

Non ancora reclutamento

Descrizione dettagliata

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

Tipo di studio

Osservativo

Iscrizione (Stimato)

2500

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

    • Georgia
      • Atlanta, Georgia, Stati Uniti, 30303
        • Grady Memorial Hospital
        • Investigatore principale:
          • Jonathan Ratcliff, MD, MPH
        • Contatto:
          • Alex Hall, DHSc, MS
        • Investigatore principale:
          • Alex Hall, DHSc, MS

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

Subjects with acute, spontaneous supratentorial intracerebral hemorrhage.

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Minimally Invasive Surgical Groups
  • 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

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)

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Modified Rankin Scale (mRS) at 180 Days
Lasso di tempo: 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.

Day 180 from baseline (±14 days)
30-Day Mortality
Lasso di tempo: Day 30 (±7 days)
All-cause mortality within 30 days of the initial hemorrhage.
Day 30 (±7 days)

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
modified Rankin Scale (mRS) at Additional Time Points
Lasso di tempo: 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.
Day 7, 30, 90, 180, 365
Post-Operative Infection or CSF Leak
Lasso di tempo: Baseline through Day 365
Incidence of surgical site infection or cerebrospinal fluid leak.
Baseline through Day 365
Quality of Life (EQ-5D-5L)
Lasso di tempo: 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)

Day 7, 30, 90, 180, 365
Follow-Up Neuroimaging (24-Hour)
Lasso di tempo: Within 24 hours post-procedure
Assessment of hematoma evacuation effectiveness and residual volume.
Within 24 hours post-procedure
In-Hospital Mortality
Lasso di tempo: From date of enrollment through the date of hospital discharge (upto 14 days)
All-cause mortality occurring during the initial hospitalization.
From date of enrollment through the date of hospital discharge (upto 14 days)
Change in Hematoma Volume
Lasso di tempo: 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.
Baseline to follow-up imaging (within first 10 days)
Post-Operative Rebleeding With Neurologic Deterioration (Surgery Group Only)
Lasso di tempo: 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)
Baseline through Day 10
Time to Intervention
Lasso di tempo: From time of enrollment through the time of procedure (upto 100 days)
Time from ictus (symptom onset) to MIS procedure.
From time of enrollment through the time of procedure (upto 100 days)
Surgical Complications
Lasso di tempo: Baseline through Day 365
Any intraoperative or postoperative complication related to Minimally invasive surgery (MIS) technique, including device-related events.
Baseline through Day 365
Residual Post-Operative Hemorrhage Volume
Lasso di tempo: Post-operative imaging (≤10 days)
Quantification of remaining hematoma volume after MIS.
Post-operative imaging (≤10 days)
Serious Adverse Events (SAEs)
Lasso di tempo: Baseline through Day 365
SAEs include events resulting in death, life-threatening conditions, hospitalization, disability, or events requiring medical/surgical intervention.
Baseline through Day 365
Hospital Length of Stay
Lasso di tempo: From date of enrollment to the date of discharge (upto 4 weeks or more)
Total number of days from hospital admission to discharge.
From date of enrollment to the date of discharge (upto 4 weeks or more)
Decompressive Hemicraniectomy
Lasso di tempo: Baseline through discharge (upto 100 days or more)
Receipt of decompressive hemicraniectomy during the initial hospitalization.
Baseline through discharge (upto 100 days or more)
ICU Length of Stay
Lasso di tempo: From date of enrollment to the date of ICU discharge (upto 100 days or more)
Number of days from ICU admission to ICU discharge.
From date of enrollment to the date of ICU discharge (upto 100 days or more)
Duration of Mechanical Ventilation
Lasso di tempo: Time from enrollment to the time mechanical ventilation was stopped (upto 100 days or more)
Total duration of mechanical ventilation during the initial hospitalization.
Time from enrollment to the time mechanical ventilation was stopped (upto 100 days or more)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Collaboratori

Investigatori

  • Investigatore principale: Alex Hall, DHSc, Emory University
  • Investigatore principale: Gustavo Pradilla, MD, Emory University
  • Investigatore principale: Jonathan Ratcliff,, MD, MPH, Emory University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 giugno 2026

Completamento primario (Stimato)

1 giugno 2033

Completamento dello studio (Stimato)

1 giugno 2033

Date di iscrizione allo studio

Primo inviato

23 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

11 giugno 2026

Primo Inserito (Effettivo)

16 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

16 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

11 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

Descrizione del piano IPD

Data will be shared for special requests. REACH Trial must have the primary paper published, and the first 3 papers from the registry must be complete before the data becomes available for sharing.

Criteri di accesso alla condivisione IPD

Request to REACH Registry Executive Committee and/or REACH Registry Publications and Data Management Committee (PDMC)

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA
  • CODICE_ANALITICO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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