Trauma Molecular Processes

NCT07683169 — Recruiting, 500 participants, Mario Negri Institute for Pharmacological Research

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

RegistryNCT07683169, acronym TRAUMAP
StatusRecruiting
Study typeObservational
Enrollment500 (Estimated)
SponsorMario Negri Institute for Pharmacological Research (Other); collaborators: A.O. Ospedale Papa Giovanni XXIII, Fondazione IRCCS San Gerardo dei Tintori
ConditionsTraumatic Brain Injury
Datesstart 2024-10-18, primary completion 2044-10-01 (estimated), completion 2044-10-01 (estimated), first posted 2026-07-06, last updated 2026-07-06
Locations2 sites in Italy

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-Summary

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.

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+Detailed description

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.

+Outcome measures

Primary outcomes

  • Tissue Used for Future Research Studies [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

+Eligibility

Sex: All, ages: 18 Years to any

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.

+Locations (2)

FacilityCityCountryStatus
Asst Papa Giovanni XxiiiBergamoItalyRecruiting
Fondazione IRCCS San Gerardo dei TintoriMonzaItalyRecruiting