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Intracerebral HemorrhagePARTENOPENCT07580326

Microplastics in Brain Hematomas and Neurological Outcomes After Intracerebral Hemorrhage

An observational study of Intracerebral Hemorrhage and Brain Hematoma, run by University of Campania Luigi Vanvitelli at 1 site in Italy.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Intracerebral Hemorrhage, Brain Hematoma
What is being tested?
Observational Analysis
How many people
150 participants
Where
1 siteItaly
Study dates
1 Jun 2024to 1 Jun 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: 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.

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Italy1 site
  • University Hospital Luigi Vanvitelli

    Naples, 80138

Other trials in Italy

About this study

Official title: 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.

Read more

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.

Read the detailed description

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.

Being tested
Observational Analysis
Keywords
Microplastics, Nanoplastics, Neuroinflammation, Blood-Brain Barrier, Environmental Exposure
Medical subject headings
Cerebral Hemorrhage, Neuroinflammatory Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Observational AnalysisOther

    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.

Study groups in NCT07580326
Study groupRoleWhat they receive
Intracerebral Hemorrhage PatientsPatients 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.
Receives: Other: Observational Analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Concentration of Micro- and Nanoplastics in Intracerebral Hematoma Tissue

    Quantification of micro- and nanoplastics in intracerebral hematoma tissue samples collected during surgical evacuation.

    Measured: Baseline (intraoperative sampling)

Secondary outcomes (3)
  1. Modified Rankin Scale Score

    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.

    Measured: 12 months

  2. Circulating Concentrations of Inflammatory Biomarkers

    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.

    Measured: Baseline

  3. Concentration of Circulating Micro- and Nanoplastics

    Concentration of circulating micro- and nanoplastics measured in peripheral blood samples and evaluated in relation to micro- and nanoplastic burden in intracerebral hematoma tissue.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 May 2026
  2. Study start1 Jun 2024
  3. Primary completion1 Jan 2025
  4. Study completion1 Jun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07580326
Sponsor's protocol ID
PARTENOPE-ICH-01
Other IDs
DAMSS-CIAMC-2026
Acronym
PARTENOPE
Status last verified
May 2026
First submitted
5 May 2026
Last updated
2 Jun 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Prattichizzo F, Ceriello A, Pellegrini V, La Grotta R, Graciotti L, Olivieri F, Paolisso P, D'Agostino B, Iovino P, Balestrieri ML, Rajagopalan S, Landrigan PJ, Marfella R, Paolisso G. Micro-nanoplastics and cardiovascular diseases: evidence and perspectives. Eur Heart J. 2024 Oct 7;45(38):4099-4110. doi: 10.1093/eurheartj/ehae552.

    PubMed 39240674
  • Marfella R, Kallweit U. Neurotoxicity at the Tides: A Call to Action on Marine Microplastics and Brain Health. Eur J Neurol. 2025 May;32(5):e70181. doi: 10.1111/ene.70181. No abstract available.

    PubMed 40407259
  • Marfella R, Prattichizzo F, Paolisso G. Microplastics and nanoplastics: tiny threats for cardiovascular diseases? Cardiovasc Res. 2025 Oct 24;121(12):1793-1795. doi: 10.1093/cvr/cvaf143. No abstract available.

    PubMed 40919846
  • Marfella R, Carreras F, Prattichizzo F, La Grotta R, Pellegrini V, Sardu C, D'Onofrio N, Barbieri M, Municino M, Siniscalchi M, Spinetti F, Vigliotti G, Vecchione C, Carrizzo A, Accarino G, Squillante A, Spaziano G, Mirra D, Esposito R, Fenti A, Galoppo S, Canzano S, Marfella LV, Falco G, Balestrieri ML, Mauro C, Ceriello A, Landrigan PJ, D'Agostino B, Iovino P, Paolisso G. Detection and Proinflammatory Effects of BTEX within the Human Atherosclerotic Plaque. Environ Sci Technol. 2025 Dec 23;59(50):27044-27056. doi: 10.1021/acs.est.5c04941. Epub 2025 Dec 11.

    PubMed 41381046
  • D'Onofrio N, Donisi I, Del Vecchio V, Prattichizzo F, Pellegrini V, Barbieri M, Ceriello A, Marfella R, Paolisso G, Balestrieri ML. PCSK9 inhibition ameliorates microplastic-induced endothelial redox imbalance via SIRT6 modulation. Cell Mol Biol Lett. 2025 Dec 22;31(1):9. doi: 10.1186/s11658-025-00838-z.

    PubMed 41430105
  • Marfella R, Prattichizzo F, Barbieri M, Paolisso P, Scisciola L, Basilicata MG, Marfella LV, Pesapane A, Fenti A, La Grotta R, Carreras F, Iovino P, Barbato E, Ceriello A, Landrigan PJ, Paolisso G. Microplastics and Atherosclerosis: Mechanisms. Annu Rev Pharmacol Toxicol. 2026 Jan;66(1):369-390. doi: 10.1146/annurev-pharmtox-062124-113011.

    PubMed 41577449
  • Donisi I, Sardu C, Colloca A, Balestrieri A, Vecchio VD, Marfella R, Campanile G, D'Onofrio N, Balestrieri ML. In vitro evidence and integrative bioinformatics identify the SGLT2-PPARgamma axis as a target against polyethylene microplastic-driven metabolic reprogramming in colorectal cancer cells. J Transl Med. 2026 Feb 2;24(1):312. doi: 10.1186/s12967-026-07776-0.

    PubMed 41629945
  • Prattichizzo F, Paolisso G, Iovino P, Marfella R. Microplastics and nanoplastics: Novel components of the environmental exposome associated with cardiovascular diseases. Trends Cardiovasc Med. 2026 Mar 12:S1050-1738(26)00038-1. doi: 10.1016/j.tcm.2026.03.003. Online ahead of print. No abstract available.

    PubMed 41831807
  • Marfella R, Fumagalli C, Marfella LV, Furbatto F, Fenti A, Paolisso P, Sardu C, Prattichizzo F, Iovino P, Mauro C. Environmental Pollutant-Induced Cardiopathogenesis Through Immune Dysfunction: The Emerging Role of Micro- and Nanoplastics. Can J Cardiol. 2026 Aug;42(8):1889-1901. doi: 10.1016/j.cjca.2026.03.050. Epub 2026 Apr 8.

    PubMed 41962839
  • Leslie HA, van Velzen MJM, Brandsma SH, Vethaak AD, Garcia-Vallejo JJ, Lamoree MH. Discovery and quantification of plastic particle pollution in human blood. Environ Int. 2022 May;163:107199. doi: 10.1016/j.envint.2022.107199. Epub 2022 Mar 24.

    PubMed 35367073
  • Marfella R, Prattichizzo F, Sardu C, Fulgenzi G, Graciotti L, Spadoni T, D'Onofrio N, Scisciola L, La Grotta R, Frige C, Pellegrini V, Municino M, Siniscalchi M, Spinetti F, Vigliotti G, Vecchione C, Carrizzo A, Accarino G, Squillante A, Spaziano G, Mirra D, Esposito R, Altieri S, Falco G, Fenti A, Galoppo S, Canzano S, Sasso FC, Matacchione G, Olivieri F, Ferraraccio F, Panarese I, Paolisso P, Barbato E, Lubritto C, Balestrieri ML, Mauro C, Caballero AE, Rajagopalan S, Ceriello A, D'Agostino B, Iovino P, Paolisso G. Microplastics and Nanoplastics in Atheromas and Cardiovascular Events. N Engl J Med. 2024 Mar 7;390(10):900-910. doi: 10.1056/NEJMoa2309822.

    PubMed 38446676

Questions about this trial

What is this clinical trial studying?

An observational study of Intracerebral Hemorrhage and Brain Hematoma, run by University of Campania Luigi Vanvitelli at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Concentration of Micro- and Nanoplastics in Intracerebral Hematoma Tissue (time frame: Baseline (intraoperative sampling)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07580326, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.

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PARTENOPE Clinical Trial NCT07580326 | AzTrials