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Recruiting NCT07292766

Metabolomic Profiling of Patients With Traumatic Brain Injury

Observational Traumatic Brain Injury Traumatic Brain Injury (TBI) Patients

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Traumatic Brain Injury, Traumatic Brain Injury (TBI) Patients. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Primary outcome measures

  • metabolomic analysis [Time frame: Day 1]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

Turkey (Türkiye) · 1 center
  • Aksaray University — Aksaray

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. PMID 37481590
  • 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. PMID 38556884
  • 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. PMID 37845610

Identifiers

NCT: NCT07292766 · TBI_omics

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗