Metabolomic Profiling of Patients With Traumatic Brain Injury
1 other identifier
observational
60
1 country
1
Brief 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. This study aimed to examine the differences in metabolite levels between trauma patients with severe TBI and orthopedic trauma patients without brain injury.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Feb 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2024
CompletedFirst Submitted
Initial submission to the registry
July 28, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2025
CompletedFirst Posted
Study publicly available on registry
December 18, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2026
CompletedDecember 18, 2025
December 1, 2025
1.8 years
July 28, 2025
December 17, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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".
Day 1
Study Arms (2)
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
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- Presence of brain pathology in the pre-trauma period
- Patient with chronic subdural hematoma
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Aksaray University
Aksaray, Ankara, 06810, Turkey (Türkiye)
Related Publications (3)
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.
PMID: 37481590RESULTZhou 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.
PMID: 38556884RESULTFedoruk 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.
PMID: 37845610RESULT
Biospecimen
venous blood sample for metabolomic analysis
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Attending anesthesiologist
Study Record Dates
First Submitted
July 28, 2025
First Posted
December 18, 2025
Study Start
February 1, 2024
Primary Completion
December 1, 2025
Study Completion
February 1, 2026
Last Updated
December 18, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share