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Metabolomic Profiling of Patients With Traumatic Brain Injury

NCT ID: NCT07292766

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-01

Study Completion Date

2026-02-01

Brief Summary

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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

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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.

Conditions

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Traumatic Brain Injury Traumatic Brain Injury (TBI) Patients

Keywords

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traumatic brain injury metabolomics

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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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)

No interventions assigned to this group

Non_TBI

Patients aged 18-65 years who had a traumatic injury without TBI

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Presence of brain pathology in the pre-trauma period
* Patient with chronic subdural hematoma
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ekin Guran, MD

Attending anesthesiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Aksaray University

Aksaray, Ankara, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Hazal Ekin AYTUĞ, Consultant anesthesiologist

Role: CONTACT

Phone: +905078448449

Email: [email protected]

Facility Contacts

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Hazal Ekin AYTUĞ

Role: primary

References

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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.

Reference Type RESULT
PMID: 37481590 (View on PubMed)

Zhou 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.

Reference Type RESULT
PMID: 38556884 (View on PubMed)

Fedoruk 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.

Reference Type RESULT
PMID: 37845610 (View on PubMed)

Other Identifiers

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TBI_omics

Identifier Type: -

Identifier Source: org_study_id