Tämä sivu käännettiin automaattisesti, eikä käännösten tarkkuutta voida taata. Katso englanninkielinen versio lähdetekstiä varten.

Rapid Evacuation and Access of Cerebral Hemorrhage Registry (REACH)

maanantai 24. elokuuta 2026 päivittänyt: 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.

Tutkimuksen yleiskatsaus

Tila

Rekrytointi

Yksityiskohtainen kuvaus

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

Opintotyyppi

Havainnollistava

Ilmoittautuminen (Arvioitu)

2500

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskeluyhteys

Opiskelupaikat

    • Georgia
      • Atlanta, Georgia, Yhdysvallat, 30303
        • Rekrytointi
        • Grady Memorial Hospital
        • Päätutkija:
          • Jonathan Ratcliff, MD, MPH
        • Ottaa yhteyttä:
          • Alex Hall, DHSc, MS
        • Päätutkija:
          • Alex Hall, DHSc, MS

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

  • Aikuinen
  • Vanhempi Aikuinen

Hyväksyy terveitä vapaaehtoisia

Ei

Näytteenottomenetelmä

Ei-todennäköisyysnäyte

Tutkimusväestö

Subjects with acute, spontaneous supratentorial intracerebral hemorrhage.

Kuvaus

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

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

Kohortit ja interventiot

Ryhmä/Kohortti
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)

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Modified Rankin Scale (mRS) at 180 Days
Aikaikkuna: 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
Aikaikkuna: Day 30 (±7 days)
All-cause mortality within 30 days of the initial hemorrhage.
Day 30 (±7 days)

Muut tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
modified Rankin Scale (mRS) at Additional Time Points
Aikaikkuna: 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
Aikaikkuna: Baseline through Day 365
Incidence of surgical site infection or cerebrospinal fluid leak.
Baseline through Day 365
Quality of Life (EQ-5D-5L)
Aikaikkuna: 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)
Aikaikkuna: Within 24 hours post-procedure
Assessment of hematoma evacuation effectiveness and residual volume.
Within 24 hours post-procedure
In-Hospital Mortality
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: Post-operative imaging (≤10 days)
Quantification of remaining hematoma volume after MIS.
Post-operative imaging (≤10 days)
Serious Adverse Events (SAEs)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Sponsori

Yhteistyökumppanit

Tutkijat

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

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan ​​julkisella verkkosivustolla.

Opi tärkeimmät päivämäärät

Opiskelun aloitus (Todellinen)

Keskiviikko 12. elokuuta 2026

Ensisijainen valmistuminen (Arvioitu)

Keskiviikko 1. kesäkuuta 2033

Opintojen valmistuminen (Arvioitu)

Keskiviikko 1. kesäkuuta 2033

Opintoihin ilmoittautumispäivät

Ensimmäinen lähetetty

Lauantai 23. toukokuuta 2026

Ensimmäinen toimitettu, joka täytti QC-kriteerit

Torstai 11. kesäkuuta 2026

Ensimmäinen Lähetetty (Todellinen)

Tiistai 16. kesäkuuta 2026

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Todellinen)

Keskiviikko 26. elokuuta 2026

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

Maanantai 24. elokuuta 2026

Viimeksi vahvistettu

Lauantai 1. elokuuta 2026

Lisää tietoa

Tähän tutkimukseen liittyvät termit

Yksittäisten osallistujien tietojen suunnitelma (IPD)

Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?

JOO

IPD-suunnitelman kuvaus

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.

IPD-jaon käyttöoikeuskriteerit

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

IPD-jakamista tukeva tietotyyppi

  • STUDY_PROTOCOL
  • MAHLA
  • ANALYTIC_CODE

Lääke- ja laitetiedot, tutkimusasiakirjat

Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta

Ei

Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta

Ei

Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .

Tilaa