Trauma Molecular Processes (TRAUMAP)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Traumatic Brain Injury

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.

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Elisa R Zanier, MD; Phone Number: +390239014204; Email: elisa.zanier@marionegri.it
• Study Contact Backup: Name: Francesca Pischiutta, PhD; Phone Number: +390239014377; Email: francesca.pischiutta@marionegri.it

Study Locations

• Italy
  • Bergamo, Italy
    • Recruiting
    • ASST Papa Giovanni XXIII
  • Monza, Italy
    • Recruiting
    • Fondazione IRCCS San Gerardo dei Tintori

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult subjects

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tissue Used for Future Research Studies	Tissue collected through the study will be stored and used in future approved research studies	Time frame as clinically indicated, maximum 2 weeks after TBI

Collaborators and Investigators

• Sponsor: Mario Negri Institute for Pharmacological Research
• Collaborators: A.O. Ospedale Papa Giovanni XXIII; Fondazione IRCCS San Gerardo dei Tintori

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2024
• Primary Completion (Estimated): October 1, 2044
• Study Completion (Estimated): October 1, 2044

Study Registration Dates

• First Submitted: June 26, 2026
• First Submitted That Met QC Criteria: July 2, 2026
• First Posted (Actual): July 6, 2026

Study Record Updates

• Last Update Posted (Actual): July 6, 2026
• Last Update Submitted That Met QC Criteria: July 2, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: traumatic brain injury; biopsy; contusion; brain resection
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Wounds, Nonpenetrating; Brain Injuries; Brain Injuries, Traumatic; Contusions
• Other Study ID Numbers: TRAUMAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No