- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07651631
Rapid Evacuation and Access of Cerebral Hemorrhage Registry (REACH)
A Prospective, Multicenter, Global Registry Evaluating Minimally Invasive Surgery for the Treatment of Acute Spontaneous Supratentorial Intracerebral Hemorrhage.
Přehled studie
Postavení
Podmínky
Detailní popis
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 studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní kontakt
- Jméno: Alex Hall, DHSc
- Telefonní číslo: 404-778-1585
- E-mail: alex.hall@emory.edu
Studijní místa
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Georgia
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Atlanta, Georgia, Spojené státy, 30303
- Grady Memorial Hospital
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Vrchní vyšetřovatel:
- Jonathan Ratcliff, MD, MPH
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Kontakt:
- Alex Hall, DHSc, MS
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Vrchní vyšetřovatel:
- Alex Hall, DHSc, MS
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Metoda odběru vzorků
Studijní populace
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
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Minimally Invasive Surgical Groups
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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):
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Modified Rankin Scale (mRS) at 180 Days
Časové okno: Day 180 from baseline (±14 days)
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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)
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30-Day Mortality
Časové okno: Day 30 (±7 days)
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All-cause mortality within 30 days of the initial hemorrhage.
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Day 30 (±7 days)
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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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modified Rankin Scale (mRS) at Additional Time Points
Časové okno: Day 7, 30, 90, 180, 365
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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.
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Day 7, 30, 90, 180, 365
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Post-Operative Infection or CSF Leak
Časové okno: Baseline through Day 365
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Incidence of surgical site infection or cerebrospinal fluid leak.
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Baseline through Day 365
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Quality of Life (EQ-5D-5L)
Časové okno: Day 7, 30, 90, 180, 365
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The EQ-5D-5L assesses health status across five dimensions:
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
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Follow-Up Neuroimaging (24-Hour)
Časové okno: Within 24 hours post-procedure
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Assessment of hematoma evacuation effectiveness and residual volume.
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Within 24 hours post-procedure
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In-Hospital Mortality
Časové okno: From date of enrollment through the date of hospital discharge (upto 14 days)
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All-cause mortality occurring during the initial hospitalization.
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From date of enrollment through the date of hospital discharge (upto 14 days)
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Change in Hematoma Volume
Časové okno: Baseline to follow-up imaging (within first 10 days)
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Difference between initial hematoma volume and follow-up neuroimaging volume, assessed centrally by the Neuroimaging Core Lab.
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Baseline to follow-up imaging (within first 10 days)
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Post-Operative Rebleeding With Neurologic Deterioration (Surgery Group Only)
Časové okno: Baseline through Day 10
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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)
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Baseline through Day 10
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Time to Intervention
Časové okno: From time of enrollment through the time of procedure (upto 100 days)
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Time from ictus (symptom onset) to MIS procedure.
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From time of enrollment through the time of procedure (upto 100 days)
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Surgical Complications
Časové okno: Baseline through Day 365
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Any intraoperative or postoperative complication related to Minimally invasive surgery (MIS) technique, including device-related events.
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Baseline through Day 365
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Residual Post-Operative Hemorrhage Volume
Časové okno: Post-operative imaging (≤10 days)
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Quantification of remaining hematoma volume after MIS.
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Post-operative imaging (≤10 days)
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Serious Adverse Events (SAEs)
Časové okno: Baseline through Day 365
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SAEs include events resulting in death, life-threatening conditions, hospitalization, disability, or events requiring medical/surgical intervention.
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Baseline through Day 365
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Hospital Length of Stay
Časové okno: From date of enrollment to the date of discharge (upto 4 weeks or more)
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Total number of days from hospital admission to discharge.
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From date of enrollment to the date of discharge (upto 4 weeks or more)
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Decompressive Hemicraniectomy
Časové okno: Baseline through discharge (upto 100 days or more)
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Receipt of decompressive hemicraniectomy during the initial hospitalization.
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Baseline through discharge (upto 100 days or more)
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ICU Length of Stay
Časové okno: From date of enrollment to the date of ICU discharge (upto 100 days or more)
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Number of days from ICU admission to ICU discharge.
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From date of enrollment to the date of ICU discharge (upto 100 days or more)
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Duration of Mechanical Ventilation
Časové okno: Time from enrollment to the time mechanical ventilation was stopped (upto 100 days or more)
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Total duration of mechanical ventilation during the initial hospitalization.
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Time from enrollment to the time mechanical ventilation was stopped (upto 100 days or more)
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Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Alex Hall, DHSc, Emory University
- Vrchní vyšetřovatel: Gustavo Pradilla, MD, Emory University
- Vrchní vyšetřovatel: Jonathan Ratcliff,, MD, MPH, Emory University
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Cerebrovaskulární poruchy
- Onemocnění mozku
- Onemocnění centrálního nervového systému
- Nemoci nervového systému
- Cévní onemocnění
- Kardiovaskulární choroby
- Patologické procesy
- Krvácení
- Vrozené vady
- Kardiovaskulární abnormality
- Intrakraniální krvácení
- Cévní malformace
- Vrozené, dědičné a neonatální nemoci a abnormality
- Patologické stavy, příznaky a symptomy
- Mozkové krvácení
- Arteriovenózní malformace
Další identifikační čísla studie
- 2026P000373
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Kritéria přístupu pro sdílení IPD
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- MÍZA
- ANALYTIC_CODE
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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