NCT07683169

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
221mo left

Started Oct 2024

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress9%
Oct 2024Oct 2044

Study Start

First participant enrolled

October 18, 2024

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

June 26, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 6, 2026

Completed
18.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2044

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2044

Last Updated

July 6, 2026

Status Verified

July 1, 2026

Enrollment Period

20 years

First QC Date

June 26, 2026

Last Update Submit

July 2, 2026

Conditions

Traumatic Brain Injury

Keywords

traumatic brain injurycontusionbrain resectionbiopsy

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult subjects

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Asst Papa Giovanni Xxiii

Bergamo, Italy

RECRUITING

Fondazione IRCCS San Gerardo dei Tintori

Monza, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Brain tissue samples collected during surgical resection of a traumatic contusion

MeSH Terms

Conditions

Brain Injuries, TraumaticContusions

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesWounds, Nonpenetrating

Central Study Contacts

Elisa R Zanier, MD

CONTACT

+390239014204elisa.zanier@marionegri.it

Francesca Pischiutta, PhD

CONTACT

+390239014377francesca.pischiutta@marionegri.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2026

First Posted

July 6, 2026

Study Start

October 18, 2024

Primary Completion (Estimated)

October 1, 2044

Study Completion (Estimated)

October 1, 2044

Last Updated

July 6, 2026

Record last verified: 2026-07

Locations

IT(2)