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Microplastics in Brain Hematomas and Neurological Outcomes After Intracerebral Hemorrhage (PARTENOPE)

29. Mai 2026 aktualisiert von: Raffaele Marfella, University of Campania Luigi Vanvitelli

Plastic Accumulation in Residual Brain Tissues From Hemorrhagic Events: Neurological Outcomes and Pathogenetic Evidence (PARTENOPE Study)

This observational study investigates the presence of micro- and nanoplastics in surgically removed intracerebral hematomas and their association with neurological outcomes in patients with spontaneous intracerebral hemorrhage.

Microplastics have recently been identified in human tissues and are increasingly recognized as potential contributors to inflammation and vascular dysfunction. However, their role in cerebrovascular diseases, particularly intracerebral hemorrhage, remains unknown.

Patients undergoing surgical hematoma evacuation will be enrolled. Brain tissue and blood samples will be analyzed using advanced spectroscopic and imaging techniques to detect and characterize micro- and nanoplastics.

The study aims to evaluate whether the presence of these particles is associated with increased inflammation, worse neurological outcomes, and higher risk of adverse cerebrovascular events.

This research may provide novel insights into the impact of environmental pollutants on brain vascular disease and patient prognosis.

Studienübersicht

Status

Aktiv, nicht rekrutierend

Intervention / Behandlung

Detaillierte Beschreibung

Spontaneous intracerebral hemorrhage is a severe and life-threatening neurological condition representing approximately 10-15% of all strokes worldwide and is associated with high early mortality and substantial long-term disability. Despite significant advances in neuroimaging, neurosurgical techniques, and neurocritical care, clinical outcomes remain poor, and the biological mechanisms underlying hemorrhage initiation, expansion, and secondary brain injury are still incompletely understood.

The pathophysiology of intracerebral hemorrhage is characterized by a complex interplay of vascular, inflammatory, and neurotoxic processes. Structural vascular alterations, endothelial dysfunction, and disruption of the blood-brain barrier contribute to vessel rupture and hematoma formation. Following the initial bleeding event, secondary brain injury is driven by hematoma-induced mechanical damage, oxidative stress, activation of resident and infiltrating immune cells, and release of pro-inflammatory mediators. Microglial activation, macrophage infiltration, and inflammasome-related pathways are recognized as important contributors to neuronal injury and neurological deterioration.

While traditional risk factors such as hypertension and small vessel disease are well established, the contribution of environmental exposures to cerebrovascular vulnerability has been largely overlooked. In recent decades, environmental exposure to micro- and nanoplastics has emerged as a global health concern. The exponential increase in plastic production has resulted in widespread distribution of plastic-derived particles across ecosystems, leading to chronic human exposure through ingestion, inhalation, and dermal contact.

Microplastics and nanoplastics have been detected in multiple biological matrices, including blood, lung tissue, placenta, and cardiovascular structures. Experimental and translational studies suggest that these particles may interact with biological systems by promoting oxidative stress, immune activation, endothelial dysfunction, and tissue inflammation. Microplastics and nanoplastics have also been described in vascular tissues, supporting the rationale for investigating their potential association with cerebrovascular disease.

The central nervous system is particularly susceptible to vascular and inflammatory insults, and preservation of blood-brain barrier integrity plays a critical role in maintaining neural homeostasis. Emerging evidence indicates that nanoscale particles may cross biological barriers and potentially contribute to neuroinflammation, microglial activation, and neuronal dysfunction. However, the presence, distribution, and potential biological impact of microplastics and nanoplastics in cerebrovascular diseases, particularly intracerebral hemorrhage, have not been systematically investigated.

The PARTENOPE study (Plastic Accumulation in Residual Brain Tissues from Hemorrhagic Events: Neurological Outcomes and Pathogenetic Evidence) has been designed to address this knowledge gap. This observational cohort study integrates retrospective and prospective data collection and adopts a translational approach combining clinical characterization, advanced analytical chemistry, and biological investigation.

Study Design and Population

The study includes adult patients diagnosed with spontaneous intracerebral hemorrhage undergoing neurosurgical hematoma evacuation. Both retrospectively identified cases and prospectively enrolled patients are included to capture a broad spectrum of clinical presentations and improve the robustness and generalizability of findings.

Patients with traumatic intracranial hemorrhage, intracranial neoplasms, or vascular malformations are excluded to ensure a homogeneous population focused on primary spontaneous hemorrhagic events.

Biological Sample Collection and Contamination Control

Intracerebral hematoma samples are collected intraoperatively using standardized protocols specifically designed to minimize environmental contamination. Measures include the use of non-plastic surgical instruments, glass collection systems, and controlled laboratory environments to preserve sample integrity and minimize external contamination.

Peripheral blood samples are obtained to assess systemic exposure to microplastics and nanoplastics and to enable comparative analyses between circulating and tissue-associated particle burden.

Analytical Characterization of Microplastics and Nanoplastics

Identification and characterization of microplastics and nanoplastics are performed using a multimodal analytical platform integrating advanced spectroscopic and imaging techniques. These techniques include scanning electron microscopy with energy-dispersive X-ray spectroscopy, Fourier-transform infrared spectroscopy, Raman spectroscopy, and pyrolysis gas chromatography-mass spectrometry.

This integrated analytical approach enables high-resolution characterization of particle size, morphology, and polymer composition. Quantitative analyses provide estimates of particle burden within hematoma tissue, while qualitative analyses identify polymer types and potential environmental sources.

Spatial mapping analyses are also conducted to determine localization of particles within the hematoma matrix, including their presence in extracellular compartments and their potential interaction with inflammatory cells such as macrophages.

Clinical and Radiological Characterization

Comprehensive clinical data are collected, including demographic variables, cardiovascular risk factors, medication exposure, and comorbid conditions. Radiological assessment includes hematoma volume, location, and imaging characteristics derived from computed tomography and magnetic resonance imaging.

Perioperative variables, surgical techniques, and postoperative management are also recorded to enable integrated analysis of clinical and biological determinants of outcome.

Outcome Assessment

Patients are followed longitudinally to evaluate neurological and clinical outcomes using standardized clinical, radiological, and biological assessments.

Primary and Secondary Objectives

The primary objective of the study is to evaluate the presence and burden of microplastics and nanoplastics in intracerebral hematoma tissue and to investigate their association with neurological and cerebrovascular outcomes.

Secondary objectives include:

  • evaluating the relationship between circulating and tissue-associated particle levels
  • assessing the association between particle burden and inflammatory responses
  • exploring the potential contribution of microplastics and nanoplastics to hematoma progression and recurrence
  • characterizing the physicochemical properties and distribution of detected particles

Mechanistic and Exploratory Analyses

Exploratory analyses aim to investigate potential mechanistic pathways linking microplastic and nanoplastic exposure to neurovascular injury. These include evaluation of oxidative stress pathways, immune cell activation, endothelial dysfunction, and inflammatory signaling cascades.

Particular attention is given to macrophage activation, microglial response, and inflammasome-related pathways that may contribute to secondary brain injury after hemorrhage. The interaction between microplastics and nanoplastics and the blood-brain barrier is also explored, including their potential contribution to barrier dysfunction and increased vascular permeability.

Scientific and Clinical Implications

The PARTENOPE study represents one of the first systematic investigations of microplastics and nanoplastics in intracerebral hemorrhage. By integrating environmental exposure science with clinical neurology and advanced analytical techniques, this study aims to provide novel insights into the potential role of environmental pollutants in cerebrovascular disease.

If an association between microplastic and nanoplastic accumulation and adverse clinical outcomes is identified, these findings may have important implications for risk stratification, prevention strategies, and future research on environmental determinants of neurological disease.

Ultimately, this study seeks to contribute to a more comprehensive understanding of the factors influencing cerebrovascular health and disease progression.

Studientyp

Beobachtungs

Einschreibung (Tatsächlich)

150

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

      • Naples, Italien, 80138
        • University Hospital Luigi Vanvitelli

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

Adult patients with spontaneous intracerebral hemorrhage undergoing surgical hematoma evacuation at a tertiary care hospital. The cohort includes both retrospective and prospective cases, enabling integrated clinical, radiological, and biological analyses.

Beschreibung

Inclusion Criteria:

  • Age ≥18 years
  • Diagnosis of spontaneous intracerebral hemorrhage confirmed by CT or MRI
  • Indication for surgical hematoma evacuation
  • Availability of intracerebral hematoma tissue sample
  • Ability to provide informed consent (patient or legal representative)

Exclusion Criteria:

  • Traumatic intracerebral hemorrhage
  • Intracranial neoplasms
  • Known vascular malformations (e.g., arteriovenous malformations, aneurysms)
  • Severe systemic infection or sepsis at admission
  • Inadequate or contaminated biological samples
  • Refusal or inability to provide informed consent

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
Intracerebral Hemorrhage Patients
Patients with spontaneous intracerebral hemorrhage undergoing surgical hematoma evacuation. Micro- and nanoplastics will be measured in hematoma tissue and blood samples, and associations with clinical outcomes will be evaluated.
No intervention is administered as part of the study. All patients receive standard clinical care according to current guidelines for intracerebral hemorrhage. Biological samples, including intracerebral hematoma tissue and peripheral blood, are collected for observational analysis of micro- and nanoplastics and their association with clinical, radiological, and biological outcomes.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Concentration of Micro- and Nanoplastics in Intracerebral Hematoma Tissue
Zeitfenster: Baseline (intraoperative sampling)
Quantification of micro- and nanoplastics in intracerebral hematoma tissue samples collected during surgical evacuation.
Baseline (intraoperative sampling)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Modified Rankin Scale Score
Zeitfenster: 12 months
Neurological outcome assessed using the modified Rankin Scale, a 7-point functional outcome scale ranging from 0 (no symptoms) to 6 (death), where higher scores indicate worse neurological disability.micro- and nanoplastic burden.
12 months
Circulating Concentrations of Inflammatory Biomarkers
Zeitfenster: Baseline
Measurement of circulating inflammatory biomarkers, including interleukin-6 (IL-6) and tumor necrosis factor-alpha (TNF-alpha), and their association with micro- and nanoplastics.hematoma tissue samples collected during surgical evacuation. Neurological outcome will be assessed using the modified Rankin Scale (mRS), a 7-point functional outcome scale ranging from 0 (no symptoms) to 6 (death), where higher scores indicate worse neurological disability.
Baseline
Concentration of Circulating Micro- and Nanoplastics
Zeitfenster: Baseline
Concentration of circulating micro- and nanoplastics measured in peripheral blood samples and evaluated in relation to micro- and nanoplastic burden in intracerebral hematoma tissue.
Baseline

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Hematoma Volume
Zeitfenster: Baseline
Measurement of intracerebral hematoma volume assessed by CT imaging and its association with micro- and nanoplastic burden.
Baseline

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. Juni 2024

Primärer Abschluss (Tatsächlich)

1. Januar 2025

Studienabschluss (Geschätzt)

1. Juni 2026

Studienanmeldedaten

Zuerst eingereicht

5. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

5. Mai 2026

Zuerst gepostet (Tatsächlich)

12. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

2. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

29. Mai 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

De-identified individual participant data (IPD) will be made available upon reasonable request after publication of the primary results. Data will be shared with qualified researchers for scientific purposes, subject to institutional approval and data sharing agreements.

IPD-Sharing-Zeitrahmen

De-identified individual participant data and supporting documents will be available beginning 6 months after publication of the primary results and will remain available for at least 5 years.

IPD-Sharing-Zugriffskriterien

Data will be available to qualified researchers with a scientifically sound research proposal. Requests will be reviewed by the study investigators and the institution. Data will be shared following approval and completion of a data sharing agreement to ensure confidentiality and appropriate use.

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL
  • SAFT

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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