Microplastics in Brain Hematomas and Neurological Outcomes After Intracerebral Hemorrhage

NCT07580326 | Active Not Recruiting

• 2 other identifiers: PARTENOPE-ICH-01DAMSS-CIAMC-2026
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Brain Hematoma; Intracerebral Hemorrhage

Keywords

Microplastics; Nanoplastics; Neuroinflammation; Blood-Brain Barrier; Environmental Exposure

Outcome Measures

Primary Outcomes (1)

• Presence of Micro- and Nanoplastics in Intracerebral Hematoma Tissue and Association With Neurological Outcome

  Micro- and nanoplastics (MNPs) will be identified and quantified in intracerebral hematoma tissue samples collected during surgical evacuation. The presence and burden of MNPs will be evaluated in relation to neurological outcome assessed by the modified Rankin Scale (mRS) at 12 months.

  Baseline (intraoperative sampling) and 12 months follow-up

Secondary Outcomes (3)

• All-Cause Mortality

  In-hospital and 12 months

• Inflammatory Biomarkers

  Baseline

• Correlation Between Circulating and Tissue Microplastics

  Baseline

Other Outcomes (1)

• Hematoma Volume

  Baseline

Study Arms (1)

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.

Other: Observational Analysis

Interventions

Observational Analysis OTHER

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.

Intracerebral Hemorrhage Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Campania Luigi Vanvitelli: lead
• Federico II University: collaborator
• University of Campania Luigi Vanvitelli CIAMC Research Center: collaborator
• IRCCS Multimedica: collaborator

Study Sites (1)

University Hospital Luigi Vanvitelli

Naples, 80138, Italy

Location

Related Publications (11)

• 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.

  PMID: 39240674 RESULT

• 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.

  PMID: 40407259 RESULT

• 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.

  PMID: 40919846 RESULT

• 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.

  PMID: 41381046 RESULT

• 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.

  PMID: 41430105 RESULT

• 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.

  PMID: 41577449 RESULT

• 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.

  PMID: 41629945 RESULT

• 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.

  PMID: 41831807 RESULT

• 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 Apr 8:S0828-282X(26)00300-4. doi: 10.1016/j.cjca.2026.03.050. Online ahead of print.

  PMID: 41962839 RESULT

• 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.

  PMID: 35367073 RESULT

• 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.

  PMID: 38446676 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Intracerebral hematoma tissue samples collected during surgical evacuation and peripheral blood samples obtained preoperatively will be retained. Samples will be processed under contamination-controlled conditions and stored for subsequent analysis of micro- and nanoplastics, as well as inflammatory, molecular, and cellular biomarkers.

MeSH Terms

Conditions

Cerebral Hemorrhage; Neuroinflammatory Diseases

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Inflammation

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 5, 2026
• First Posted: May 12, 2026
• Study Start: June 1, 2024
• Primary Completion: January 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: May 12, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 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.
• Access Criteria: 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.

Locations

IT (1)