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

NCT06537713 | Completed

• 1 other identifier: 2019/159
• Study Type: observational
• Target: 89
• Locations: 1 country
• Sites: 1

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.

Conditions

Moderate Traumatic Brain Injury; Testican-1; Ubiquitin

Outcome Measures

Primary Outcomes (1)

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

  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 Outcomes (1)

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

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

Study Arms (2)

Control Group

The control group consisted of healthy individuals without any disease who voluntarily participated in the study.

Diagnostic Test: Testican-1

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

Interventions

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.

Also known as: Ubiquitin

Control Group; Patients Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kanuni Sultan Suleyman Training and Research Hospital: lead

Study Sites (1)

Kanuni SUltan Suleyman Training and Research Hospital

Istanbul, Küçükçekmece, 34303, Turkey (Türkiye)

Location

Related Publications (14)

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• Hossain I, Rostami E, Marklund N. The management of severe traumatic brain injury in the initial postinjury hours - current evidence and controversies. Curr Opin Crit Care. 2023 Dec 1;29(6):650-658. doi: 10.1097/MCC.0000000000001094. Epub 2023 Oct 11.

  PMID: 37851061 BACKGROUND

• Shultz SR, Shah AD, Huang C, Dill LK, Schittenhelm RB, Morganti-Kossmann MC, Semple BD. Temporal proteomics of human cerebrospinal fluid after severe traumatic brain injury. J Neuroinflammation. 2022 Dec 8;19(1):291. doi: 10.1186/s12974-022-02654-0.

  PMID: 36482407 BACKGROUND

• Hossain I, Marklund N, Czeiter E, Hutchinson P, Buki A. Blood biomarkers for traumatic brain injury: A narrative review of current evidence. Brain Spine. 2023 Dec 14;4:102735. doi: 10.1016/j.bas.2023.102735. eCollection 2024.

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• Silvestro S, Raffaele I, Quartarone A, Mazzon E. Innovative Insights into Traumatic Brain Injuries: Biomarkers and New Pharmacological Targets. Int J Mol Sci. 2024 Feb 17;25(4):2372. doi: 10.3390/ijms25042372.

  PMID: 38397046 BACKGROUND

• Kim DS, Kim GW. Biofluid-based Biomarkers in Traumatic Brain Injury: A Narrative Review. Brain Neurorehabil. 2024 Mar 18;17(1):e8. doi: 10.12786/bn.2024.17.e8. eCollection 2024 Mar.

  PMID: 38585027 BACKGROUND

• Iseki K, Hagino S, Zhang Y, Mori T, Sato N, Yokoya S, Hozumi Y, Goto K, Tase C. Altered expression pattern of testican-1 mRNA after brain injury. Biomed Res. 2011 Dec;32(6):373-8. doi: 10.2220/biomedres.32.373.

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• Tongaonkar P, Chen L, Lambertson D, Ko B, Madura K. Evidence for an interaction between ubiquitin-conjugating enzymes and the 26S proteasome. Mol Cell Biol. 2000 Jul;20(13):4691-8. doi: 10.1128/MCB.20.13.4691-4698.2000.

  PMID: 10848595 BACKGROUND

• Azar S, Hasan A, Younes R, Najdi F, Baki L, Ghazale H, Kobeissy FH, Zibara K, Mondello S. Biofluid Proteomics and Biomarkers in Traumatic Brain Injury. Methods Mol Biol. 2017;1598:45-63. doi: 10.1007/978-1-4939-6952-4_3.

  PMID: 28508357 BACKGROUND

• Liu MC, Akinyi L, Scharf D, Mo J, Larner SF, Muller U, Oli MW, Zheng W, Kobeissy F, Papa L, Lu XC, Dave JR, Tortella FC, Hayes RL, Wang KK. Ubiquitin C-terminal hydrolase-L1 as a biomarker for ischemic and traumatic brain injury in rats. Eur J Neurosci. 2010 Feb;31(4):722-32. doi: 10.1111/j.1460-9568.2010.07097.x.

  PMID: 20384815 BACKGROUND

• Welch RD, Ayaz SI, Lewis LM, Unden J, Chen JY, Mika VH, Saville B, Tyndall JA, Nash M, Buki A, Barzo P, Hack D, Tortella FC, Schmid K, Hayes RL, Vossough A, Sweriduk ST, Bazarian JJ. Ability of Serum Glial Fibrillary Acidic Protein, Ubiquitin C-Terminal Hydrolase-L1, and S100B To Differentiate Normal and Abnormal Head Computed Tomography Findings in Patients with Suspected Mild or Moderate Traumatic Brain Injury. J Neurotrauma. 2016 Jan 15;33(2):203-14. doi: 10.1089/neu.2015.4149. Epub 2015 Dec 18.

  PMID: 26467555 BACKGROUND

• Papa L, Lewis LM, Silvestri S, Falk JL, Giordano P, Brophy GM, Demery JA, Liu MC, Mo J, Akinyi L, Mondello S, Schmid K, Robertson CS, Tortella FC, Hayes RL, Wang KK. Serum levels of ubiquitin C-terminal hydrolase distinguish mild traumatic brain injury from trauma controls and are elevated in mild and moderate traumatic brain injury patients with intracranial lesions and neurosurgical intervention. J Trauma Acute Care Surg. 2012 May;72(5):1335-44. doi: 10.1097/TA.0b013e3182491e3d.

  PMID: 22673263 BACKGROUND

• Mondello S, Kobeissy F, Vestri A, Hayes RL, Kochanek PM, Berger RP. Serum Concentrations of Ubiquitin C-Terminal Hydrolase-L1 and Glial Fibrillary Acidic Protein after Pediatric Traumatic Brain Injury. Sci Rep. 2016 Jun 20;6:28203. doi: 10.1038/srep28203.

  PMID: 27319802 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 31, 2024
• First Posted: August 5, 2024
• Study Start: October 1, 2020
• Primary Completion: March 31, 2021
• Study Completion: April 30, 2021
• Last Updated: August 5, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)