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

July 31, 2024 updated by: Ramiz Yazıcı, Kanuni Sultan Suleyman Training and Research Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

89

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Küçükçekmece
      • İstanbul, Küçükçekmece, Turkey, 34303
        • Kanuni Sultan Suleyman Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients with head trauma were categorized into three groups based on their GCS score: severe (3-8), moderate (9-13), and mild (14-15). The study specifically included patients over 18 years of age with moderate TBI (GCS: 9-13) who provided informed consent. Patients who were under 18 years of age, had missing data, were pregnant, had neurodegenerative disease, had Central Nervous System (CNS) infection, had cerebral palsy, or had penetrating head injury (by a cutting or piercing tool such as a firearm, knife, axe), as well as patients with severe (GCS: 3-8) or mild (GCS: 14-15) TBI, were not included in the study. 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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control Group
The control group consisted of healthy individuals without any disease who voluntarily participated in the study.
Diagnostic test: Testican-1
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
Patients Group
The study specifically included patients over 18 years of age with moderate TBI (GCS: 9-13) who provided informed consent.
Diagnostic test: Testican-1
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
The study was conducted with blood samples taken at the time of admission.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
The study was conducted with blood samples taken at the time of admission.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kanuni Sultan Suleyman Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2020

Primary Completion (Actual)

March 31, 2021

Study Completion (Actual)

April 30, 2021

Study Registration Dates

First Submitted

July 31, 2024

First Submitted That Met QC Criteria

July 31, 2024

First Posted (Estimated)

August 5, 2024

Study Record Updates

Last Update Posted (Estimated)

August 5, 2024

Last Update Submitted That Met QC Criteria

July 31, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019/159

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

It can be shared upon reaching the corresponding author.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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