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Trauma Molecular Processes

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07683169
Acronym
TRAUMAP
Enrollment
500
Registered
2026-07-06
Start date
2024-10-18
Completion date
2044-10-01
Last updated
2026-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Traumatic Brain Injury

Keywords

traumatic brain injury, contusion, brain resection, biopsy

Brief 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.

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.

Interventions

None listed

Sponsors

Mario Negri Institute for Pharmacological Research
Lead SponsorOTHER
A.O. Ospedale Papa Giovanni XXIII
CollaboratorOTHER
Fondazione IRCCS San Gerardo dei Tintori
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Tissue Used for Future Research StudiesTime frame as clinically indicated, maximum 2 weeks after TBITissue collected through the study will be stored and used in future approved research studies

Countries

Italy

Contacts

CONTACTElisa R Zanier, MD
elisa.zanier@marionegri.it+390239014204
CONTACTFrancesca Pischiutta, PhD
francesca.pischiutta@marionegri.it+390239014377

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 7, 2026