ClinicalTrials.gg
RecruitingNCT07683169TRAUMAPUpdated Jul 6, 2026

Trauma Molecular Processes

An observational study in Traumatic Brain Injury, sponsored by Mario Negri Institute for Pharmacological Research. Recruiting at 2 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-06.

Sponsored by Mario Negri Institute for Pharmacological Research · Observational

From the registry’s dates

  • Started Oct 2024; still recruiting 2 years later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
500
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Traumatic Brain Injury

Keywords

  • traumatic brain injury
  • contusion
  • brain resection
  • biopsy
03

In context

Brain Injuries, Traumatic

1,721 studies on the registry are indexed under Brain Injuries, Traumatic; 447 are open to participants now.

This study's planned enrollment of 500 is above the median of 117 across 557 observational studies indexed under Brain Injuries, Traumatic.

Browse Brain Injuries, Traumatic studies →

Lead sponsor

Mario Negri Institute for Pharmacological Research is the lead sponsor of 160 studies on the registry; 37 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult subjects

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 to participate to the study.

Exclusion criteria

Exclusion Criteria:

  • Coagulation disorders or other to the planned neurosurgical procedure.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
500 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna
06

What researchers measure

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

07

Study locations

2 of 2 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2024 (actual). Primary completion is estimated for Oct 2044, 240 months after the start.

Of 228 non-industry observational studies under Brain Injuries, Traumatic, half reached primary completion within 50 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 95. This study's planned 240 months is above that.

Counting every sponsor, half of 250 studies reached it within 49 months; a quarter within 23 and three quarters within 95.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 26, 2026
First posted
Jul 6, 2026
StartActual
Oct 18, 2024
Primary completionEst.
Oct 2044
CompletionEst.
Oct 2044
Last update
Jul 6, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07683169
Collaborators
A.O. Ospedale Papa Giovanni XXIII, Fondazione IRCCS San Gerardo dei Tintori
Responsible party
Sponsor
First posted
Jul 6, 2026
Start date
Oct 18, 2024
Primary completion
Oct 2044 (estimated)
Completion
Oct 2044 (estimated)
Last update
Jul 6, 2026

Study contacts

Elisa R Zanier, MD
Contact
elisa.zanier@marionegri.it
+390239014204
Francesca Pischiutta, PhD
Contact
francesca.pischiutta@marionegri.it
+390239014377

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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