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Completed

NCT Number: NCT06537713

Diagnostic Role of Serum Testican and Ubiquitin Levels in Patients With Head Trauma

We aimed to determine if testican-1 and ubiquitin can serve as early indicators for diagnosing worsening clinical course (presence of intraparenchymal pathology) and mortality in patients with moderate traumatic brain injury.

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Key information

Conditions

Moderate Traumatic Brain Injury Testican-1 Ubiquitin

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kanuni SUltan Suleyman Training and Research Hospital

Istanbul, Küçükçekmece, 34303, Turkey (Türkiye)

About this study

The study specifically included patients over 18 years of age with moderate TBI (GCS: 9-13) who provided informed consent. The control group consisted of healthy individuals without any disease who voluntarily participated in the study. Patients with moderate TBI were divided into two groups: those with intracranial pathology (Subdural hemorrhage, epidural hemorrhage, subarachnoid hemorrhage, intraparenchymal hemorrhage, and contusion) and those without. Treatment was initiated according to ATLS in patients with moderate TBI, and blood samples taken at the time of admission to the emergency department were placed in Ethylenediaminetetraacetic acid (EDTA) tubes. The relationship between the patient's clinical scoring (GCS, ISS and AIS), brain CT results, and mortality status with testican-1 and ubiquitin levels was compared.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • being over 18 years old
  • having a GCS score between 9 and 13

Exclusion criteria

  • under 18 years of age
  • had missing data
  • were pregnant
  • had neurodegenerative disease
  • had Central Nervous System (CNS) infection
  • had cerebral palsy
  • had penetrating head injury (by a cutting or piercing tool such as a firearm, knife, axe)
  • patients with severe (GCS: 3-8) or mild (GCS: 14-15) TBI

Treatment and study plan

Testican-1

Diagnostic Test

Testican-1 and ubiquitin can serve as early indicators for diagnosing worsening clinical course and mortality in patients with moderate traumatic brain injury.

Other names: Ubiquitin

Primary outcomes

  1. Comparison of testican-1 and ubiquitin levels in patients with moderate traumatic brain injuries and a control group

    Time frame: The study was conducted with blood samples taken at the time of admission.

    We compared the plasma blood levels of biomarkers in both groups

Secondary outcomes

  1. ROC curve analysis for the prediction of intraparenchymal pathology (+)

    Time frame: The study was conducted with blood samples taken at the time of admission.

    We investigated the diagnostic value of biomarkers in detecting pathology on brain CT in patients with moderate traumatic brain injury.

Sponsors and collaborators

Lead sponsor

Kanuni Sultan Suleyman Training and Research Hospital

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 5, 2024
Registry last updated
Aug 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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