NCT07292766

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

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2024

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 28, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
17 days until next milestone

First Posted

Study publicly available on registry

December 18, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

December 18, 2025

Status Verified

December 1, 2025

Enrollment Period

1.8 years

First QC Date

July 28, 2025

Last Update Submit

December 17, 2025

Conditions

Keywords

traumatic brain injurymetabolomics

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

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

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)

RECRUITING

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.

  • 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.

  • 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.

Biospecimen

Retention: SAMPLES WITH DNA

venous blood sample for metabolomic analysis

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Central Study Contacts

Hazal Ekin AYTUĞ, Consultant anesthesiologist

CONTACT

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

Locations