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Recruiting

NCT Number: NCT07683169

Trauma Molecular Processes

The TRAUMAP study will function as a brain tissue repository for biopsy specimens from patients with traumatic brain injury undergoing brain surgery for contusion removal.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Asst Papa Giovanni Xxiii, Bergamo, Italy

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About this study

The TRAUMAP study aims to investigate the molecular and cellular mechanisms underlying secondary brain injury following traumatic brain injury (TBI) through the analysis of surgically resected contused human brain tissue. Tissue specimens will be collected from adult patients undergoing neurosurgical removal of cerebral contusions as part of routine clinical care. No additional procedures will be performed for research purposes, and only tissue that would otherwise be discarded will be used.

Brain tissue samples will undergo histological, biochemical, and molecular analyses to investigate pathways involved in neuroinflammation, cell death, neurodegeneration, and endogenous regenerative responses. Molecular findings will be correlated with clinical characteristics to improve the understanding of TBI pathophysiology, validate preclinical observations, and identify potential therapeutic targets for future neuroprotective and regenerative strategies.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults aged ≥18 years.
  • Diagnosis of traumatic brain injury (TBI).
  • Admission to the intensive care unit.
  • Clinical indication for neurosurgical evacuation of a cerebral contusion.
  • Written informed consent to participate to the study.

Exclusion criteria

  • Coagulation disorders or other contraindications to the planned neurosurgical procedure.

Treatment and study plan

Primary outcomes

  1. Tissue Used for Future Research Studies

    Time frame: Time frame as clinically indicated, maximum 2 weeks after TBI

    Tissue collected through the study will be stored and used in future approved research studies

Study contacts

Contact information is provided by the study sponsor or research team.

Elisa R Zanier, MD

CONTACT

[email protected]

+390239014204

Francesca Pischiutta, PhD

CONTACT

[email protected]

+390239014377

Sponsors and collaborators

Lead sponsor

Mario Negri Institute for Pharmacological Research

Other

Collaborators

  • A.O. Ospedale Papa Giovanni XXIII
  • Fondazione IRCCS San Gerardo dei Tintori

Registry information

Official study title

Study of Pathological and Regenerative Molecular and Cellular Processes Triggered After Traumatic Brain Injury: Analysis of Biopsy Specimens

Acronym: TRAUMAP

Important dates

Study start
2024
Primary completion
2044
Study completion
2044
First posted
Jul 6, 2026
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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