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

Completed

• Conditions: Moderate Traumatic Brain Injury; Ubiquitin; Testican-1
• Interventions: Diagnostic Test: Testican-1

• Registration Number: NCT06537713
• Lead Sponsor: Kanuni Sultan Suleyman Training and Research Hospital

Brief Summary

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.

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 Timeline

• Study Start: 2020-10-01
• Primary Completion: 2021-03-31
• Study Completion: 2021-04-30
• Status Verified: 2024-07
• Study First Submitted: 2024-07-31
• Study First Submitted QC: 2024-07-31
• Last Update Submitted: 2024-07-31
• Study First Posted: 2024-08-05
• Last Update Posted: 2024-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 89

Inclusion Criteria

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Comparison of testican-1 and ubiquitin levels in patients with moderate traumatic brain injuries and a control group	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 Outcome Measures

Name	Time	Method
ROC curve analysis for the prediction of intraparenchymal pathology (+)	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.

Trial Locations

Locations (1)

Kanuni SUltan Suleyman Training and Research Hospital; 🇹🇷 İstanbul, Küçükçekmece, Turkey