- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef 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.
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
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
Studietype
Inschrijving (Geschat)
Contacten en locaties
Studiecontact
- Naam: Alex Hall, DHSc
- Telefoonnummer: 404-778-1585
- E-mail: alex.hall@emory.edu
Studie Locaties
-
-
Georgia
-
Atlanta, Georgia, Verenigde Staten, 30303
- Werving
- Grady Memorial Hospital
-
Hoofdonderzoeker:
- Jonathan Ratcliff, MD, MPH
-
Contact:
- Alex Hall, DHSc, MS
-
Hoofdonderzoeker:
- Alex Hall, DHSc, MS
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Bemonsteringsmethode
Studie Bevolking
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
|---|
|
Minimally Invasive Surgical Groups
|
|
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):
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Modified Rankin Scale (mRS) at 180 Days
Tijdsspanne: 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
Tijdsspanne: Day 30 (±7 days)
|
All-cause mortality within 30 days of the initial hemorrhage.
|
Day 30 (±7 days)
|
Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
modified Rankin Scale (mRS) at Additional Time Points
Tijdsspanne: 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
Tijdsspanne: Baseline through Day 365
|
Incidence of surgical site infection or cerebrospinal fluid leak.
|
Baseline through Day 365
|
|
Quality of Life (EQ-5D-5L)
Tijdsspanne: Day 7, 30, 90, 180, 365
|
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
|
|
Follow-Up Neuroimaging (24-Hour)
Tijdsspanne: Within 24 hours post-procedure
|
Assessment of hematoma evacuation effectiveness and residual volume.
|
Within 24 hours post-procedure
|
|
In-Hospital Mortality
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Post-operative imaging (≤10 days)
|
Quantification of remaining hematoma volume after MIS.
|
Post-operative imaging (≤10 days)
|
|
Serious Adverse Events (SAEs)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
|
Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Alex Hall, DHSc, Emory University
- Hoofdonderzoeker: Gustavo Pradilla, MD, Emory University
- Hoofdonderzoeker: Jonathan Ratcliff,, MD, MPH, Emory University
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Cerebrovasculaire aandoeningen
- Hersenziekten
- Ziekten van het centrale zenuwstelsel
- Ziekten van het zenuwstelsel
- Vaatziekten
- Hart-en vaatziekten
- Pathologische processen
- Bloeding
- Aangeboren afwijkingen
- Cardiovasculaire afwijkingen
- Intracraniële bloedingen
- Vasculaire misvormingen
- Aangeboren, erfelijke en neonatale ziekten en afwijkingen
- Pathologische aandoeningen, tekenen en symptomen
- Hersenbloeding
- Arterioveneuze misvormingen
Andere studie-ID-nummers
- 2026P000373
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
IPD-toegangscriteria voor delen
IPD delen Ondersteunend informatietype
- LEERPROTOCOOL
- SAP
- ANALYTIC_CODE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .