Traumatic Brain InjuryNCT07292766
Metabolomic Profiling of Patients With Traumatic Brain Injury
An observational study of Traumatic Brain Injury and Traumatic Brain Injury (TBI) Patients, run by Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Traumatic Brain Injury (TBI) is a significant cause of mortality and morbidity worldwide. However, the literature on determining its severity and predicting prognosis is insufficient. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Traumatic Brain Injury, Traumatic Brain Injury (TBI) Patients
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2024to 1 Feb 2026
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Trauma patients with or without TBI, aged between 18 and 65 years, who applied to Aksaray UniversityTraining and Research Hospital will be included in the study.
Who may be able to join
- Ages 18-65
- Patients diagnosed with severe TBI clinically or according to National Institute for Health and Care Excellence (NICE) criteria (including post-traumatic imaging)
- Patients with non-TBI orthopedic or multitrauma
Who cannot join
- Presence of brain pathology in the pre-trauma period
- Patient with chronic subdural hematoma
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Aksaray University
Aksaray, Ankara, 06810
Hazal Ekin AYTUĞ, 05078448449, drekinguran@gmail.com
About this study
Traumatic Brain Injury (TBI) is a significant cause of mortality and morbidity worldwide. However, the literature on determining its severity and predicting prognosis is insufficient. This study aimed to examine the differences in metabolite levels between trauma patients with severe TBI and orthopedic trauma patients without brain injury.
Read the detailed description
Traumatic Brain Injury (TBI) is a significant cause of mortality and morbidity worldwide, particularly in young people. TBI is a complex metabolic process associated with an energy crisis resulting from multiple mechanisms, including ischemia, diffusion hypoxia, and mitochondrial dysfunction. Because metabolic derangement is a fundamental component of TBI pathophysiology, these metabolic changes may provide prognostic information and guide treatment. Additionally, the release of brain-specific metabolites (i.e., small molecules with a molecular mass below 500 Da) into the systemic circulation may provide insights into blood-brain barrier (BBB) dysfunction, a fundamental process in TBI. Metabolomic profiling studies are introductory and valuable for elucidating this metabolic process.
- Keywords
- traumatic brain injury, metabolomics
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| TBI | Patients aged 18-65 years with a diagnosis of severe TBI based on clinical or National Institute for Health and Care Excellence (NICE) criteria (post-traumatic imaging) | |
| Non_TBI | Patients aged 18-65 years who had a traumatic injury without TBI |
What is being measured
The primary outcome is the main question the study is designed to answer.
metabolomic analysis
Venous blood samples are taken from the participants after the injury. Samples will be analysed using LC/MS. All relevant metabolomes and their respective metabolic pathways will be evaluated using the "KEGG Pathway database".
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2025
- Study start1 Feb 2024
- Primary completion1 Dec 2025
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ekin Guran, MD, Aksaray University Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07292766
- Sponsor's protocol ID
- TBI_omics
- Status last verified
- Dec 2025
- First submitted
- 28 Jul 2025
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Banoei MM, Lee CH, Hutchison J, Panenka W, Wellington C, Wishart DS, Winston BW; Canadian biobank, database for Traumatic Brain Injury (CanTBI) investigators, the Canadian Critical Care Translational Biology Group (CCCTBG), the Canadian Traumatic Brain Injury Research, Clinical Network (CTRC). Using metabolomics to predict severe traumatic brain injury outcome (GOSE) at 3 and 12 months. Crit Care. 2023 Jul 22;27(1):295. doi: 10.1186/s13054-023-04573-9.
PubMed 37481590Zhou M, Liu YW, He YH, Zhang JY, Guo H, Wang H, Ren JK, Su YX, Yang T, Li JB, He WH, Ma PJ, Mi MT, Dai SS. FOXO1 reshapes neutrophils to aggravate acute brain damage and promote late depression after traumatic brain injury. Mil Med Res. 2024 Mar 31;11(1):20. doi: 10.1186/s40779-024-00523-w.
PubMed 38556884Fedoruk RP, Lee CH, Banoei MM, Winston BW. Metabolomics in severe traumatic brain injury: a scoping review. BMC Neurosci. 2023 Oct 16;24(1):54. doi: 10.1186/s12868-023-00824-1.
PubMed 37845610
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolomic Profiling of Patients With Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT07292766
- Acronym / sponsor ID
- TBI_omics
- Keywords
- traumatic brain injury, metabolomics
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 18 Dec 2025 (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.
Traumatic Brain Injury (TBI) is a significant cause of mortality and morbidity worldwide. However, the literature on determining its severity and predicting prognosis is insufficient. This study aimed to examine the differences in metabolite levels between trauma patients with severe TBI and orthopedic trauma patients without brain injury.
Detailed description
Traumatic Brain Injury (TBI) is a significant cause of mortality and morbidity worldwide, particularly in young people. TBI is a complex metabolic process associated with an energy crisis resulting from multiple mechanisms, including ischemia, diffusion hypoxia, and mitochondrial dysfunction. Because metabolic derangement is a fundamental component of TBI pathophysiology, these metabolic changes may provide prognostic information and guide treatment. Additionally, the release of brain-specific metabolites (i.e., small molecules with a molecular mass below 500 Da) into the systemic circulation may provide insights into blood-brain barrier (BBB) dysfunction, a fundamental process in TBI. Metabolomic profiling studies are introductory and valuable for elucidating this metabolic process.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TBI | – | –Patients aged 18-65 years with a diagnosis of severe TBI based on clinical or National Institute for Health and Care Excellence (NICE) criteria (post-traumatic imaging) |
| Non_TBI | – | –Patients aged 18-65 years who had a traumatic injury without TBI |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Trauma patients with or without TBI, aged between 18 and 65 years, who applied to Aksaray UniversityTraining and Research Hospital will be included in the study.
Key inclusion criteria (3 listed)
- Ages 18-65
- Patients diagnosed with severe TBI clinically or according to National Institute for Health and Care Excellence (NICE) criteria (including post-traumatic imaging)
- Patients with non-TBI orthopedic or multitrauma
Key exclusion criteria (2 listed)
- Presence of brain pathology in the pre-trauma period
- Patient with chronic subdural hematoma
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
metabolomic analysis
Time frame: Day 1
Venous blood samples are taken from the participants after the injury. Samples will be analysed using LC/MS. All relevant metabolomes and their respective metabolic pathways will be evaluated using the "KEGG Pathway database".
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 18 Dec 2025.
- Results publication: PubMed 37481590Banoei MM, Lee CH, Hutchison J, Panenka W, Wellington C, Wishart DS, Winston BW; Canadian biobank, database for Traumatic Brain Injury (CanTBI) investigators, the Canadian Critical Care Translational Biology Group (CCCTBG), the Canadian Traumatic Brain Injury Research, Clinical Network (CTRC). Using metabolomics to predict severe traumatic brain injury outcome (GOSE) at 3 and 12 months. Crit Care. 2023 Jul 22;27(1):295. doi: 10.1186/s13054-023-04573-9.
- Results publication: PubMed 38556884Zhou M, Liu YW, He YH, Zhang JY, Guo H, Wang H, Ren JK, Su YX, Yang T, Li JB, He WH, Ma PJ, Mi MT, Dai SS. FOXO1 reshapes neutrophils to aggravate acute brain damage and promote late depression after traumatic brain injury. Mil Med Res. 2024 Mar 31;11(1):20. doi: 10.1186/s40779-024-00523-w.
- Results publication: PubMed 37845610Fedoruk RP, Lee CH, Banoei MM, Winston BW. Metabolomics in severe traumatic brain injury: a scoping review. BMC Neurosci. 2023 Oct 16;24(1):54. doi: 10.1186/s12868-023-00824-1.
- Individual participant dataSharing planned: No
Related trials for Traumatic Brain Injury
Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
Enrolling by invitationPhase 1
Pilot Safety and Exploratory Efficacy of PSC-05 for the Treatment of Chronic Mild Traumatic Brain Injury
Mild Traumatic Brain Injury
RecruitingObservational study
Intracranial Pressure Monitoring in Moderate Traumatic Brain Injury
Moderate Traumatic Brain Injury
Not yet recruitingPhase 1
Nanopulse Laser Therapy
TBI (Traumatic Brain Injury)
RecruitingObservational study
Effect of Different Intravenous Fluids on Post-operative Chronic Subdural Hematoma Size and Recurrence
Chronic Subdural Hematoma
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.
1 site 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 and Traumatic Brain Injury (TBI) Patients, run by Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital at 1 site in Turkey (Türkiye).
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 3 inclusion and 2 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 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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 Hazal Ekin AYTUĞ, Consultant anesthesiologist (+905078448449, drekinguran@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
metabolomic analysis (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07292766, which also lists 3 linked publications.
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 18 Dec 2025.