Traumatic Brain InjuryTRAUMAPNCT07683169
Trauma Molecular Processes
An observational study of Traumatic Brain Injury, run by Mario Negri Institute for Pharmacological Research at 2 sites in Italy.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injury
- How many people
- 500 participants
- Where
- 2 sitesItaly
- Study dates
- 18 Oct 2024to Oct 2044
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult subjects
Who may be able to join
- 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.
Who cannot join
- Coagulation disorders or other contraindications to the planned neurosurgical procedure.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy2 sites, 2 recruiting
- Recruiting
Asst Papa Giovanni Xxiii
Bergamo
- Recruiting
Fondazione IRCCS San Gerardo dei Tintori
Monza
About this study
Official title: 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.
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.
- Conditions
- Traumatic Brain Injury
- Keywords
- traumatic brain injury, contusion, brain resection, biopsy
- Medical subject headings
- Brain Injuries, Traumatic, Contusions
What is being measured
The primary outcome is the main question the study is designed to answer.
Tissue Used for Future Research Studies
Tissue collected through the study will be stored and used in future approved research studies
Measured: Time frame as clinically indicated, maximum 2 weeks after TBI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start18 Oct 2024
- Primary completionOct 2044 (estimated)
- Study completionOct 2044 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mario Negri Institute for Pharmacological Research
- Sponsor type
- University, hospital or other
- Collaborators
- A.O. Ospedale Papa Giovanni XXIII, Fondazione IRCCS San Gerardo dei Tintori
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07683169
- Sponsor's protocol ID
- TRAUMAP
- Acronym
- TRAUMAP
- Status last verified
- Jul 2026
- First submitted
- 26 Jun 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Pathological and Regenerative Molecular and Cellular Processes Triggered After Traumatic Brain Injury: Analysis of Biopsy Specimens
- ClinicalTrials.gov ID
- NCT07683169
- Acronym / sponsor ID
- TRAUMAP / TRAUMAP
- Conditions
- Traumatic Brain Injury
- Keywords
- traumatic brain injury, contusion, brain resection, biopsy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Mario Negri Institute for Pharmacological ResearchUniversity, hospital or other
- Collaborators
- A.O. Ospedale Papa Giovanni XXIII, Fondazione IRCCS San Gerardo dei Tintori
- Study start
- 18 Oct 2024 (actual)
- Primary completion
- Oct 2044 (estimated)
- Study completion
- Oct 2044 (estimated)
- First posted
- 6 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult subjects
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- Coagulation disorders or other contraindications to the planned neurosurgical procedure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Tissue Used for Future Research Studies
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Brain Injury, run by Mario Negri Institute for Pharmacological Research at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elisa R Zanier, MD (+390239014204, elisa.zanier@marionegri.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tissue Used for Future Research Studies (time frame: Time frame as clinically indicated, maximum 2 weeks after TBI). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.