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Rapid Evacuation and Access of Cerebral Hemorrhage Registry (REACH)

24 sierpnia 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Rekrutacyjny

Warunki

Szczegółowy opis

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

Typ studiów

Obserwacyjny

Zapisy (Szacowany)

2500

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

    • Georgia
      • Atlanta, Georgia, Stany Zjednoczone, 30303
        • Rekrutacyjny
        • Grady Memorial Hospital
        • Główny śledczy:
          • Jonathan Ratcliff, MD, MPH
        • Kontakt:
          • Alex Hall, DHSc, MS
        • Główny śledczy:
          • Alex Hall, DHSc, MS

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

Subjects with acute, spontaneous supratentorial intracerebral hemorrhage.

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Kohorty i interwencje

Grupa / Kohorta
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)

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Modified Rankin Scale (mRS) at 180 Days
Ramy czasowe: 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
Ramy czasowe: Day 30 (±7 days)
All-cause mortality within 30 days of the initial hemorrhage.
Day 30 (±7 days)

Inne miary wyników

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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Współpracownicy

Śledczy

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

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

12 sierpnia 2026

Zakończenie podstawowe (Szacowany)

1 czerwca 2033

Ukończenie studiów (Szacowany)

1 czerwca 2033

Daty rejestracji na studia

Pierwszy przesłany

23 maja 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

11 czerwca 2026

Pierwszy wysłany (Rzeczywisty)

16 czerwca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

26 sierpnia 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

24 sierpnia 2026

Ostatnia weryfikacja

1 sierpnia 2026

Więcej informacji

Terminy związane z tym badaniem

Inne numery identyfikacyjne badania

  • 2026P000373

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu 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.

Kryteria dostępu do udostępniania IPD

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

Typ informacji pomocniczych dotyczących udostępniania IPD

  • PROTOKÓŁ BADANIA
  • SOK ROŚLINNY
  • ANALITYCZNY_KOD

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .