Clinical trial NCT06537713: Diagnostic Role of Serum Testican and Ubiquitin Levels in Patients With Head Trauma
Official title: Diagnostic Role of Serum Testican and Ubiquitin Levels in Patients With Head Trauma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Moderate Traumatic Brain Injury
Testican-1
Ubiquitin
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
First posted: 2024-08-05
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Comparison of testican-1 and ubiquitin levels in patients with moderate traumatic brain injuries and a control group
timeFrame: The study was conducted with blood samples taken at the time of admission.
Secondary outcomes:
measure: ROC curve analysis for the prediction of intraparenchymal pathology (+)
timeFrame: The study was conducted with blood samples taken at the time of admission.
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Kanuni SUltan Suleyman Training and Research Hospital
state: Küçükçekmece
Study officials:
References:
citation: Maas AIR, Menon DK, Manley GT, Abrams M, Akerlund C, Andelic N, Aries M, Bashford T, Bell MJ, Bodien YG, Brett BL, Buki A, Chesnut RM, Citerio G, Clark D, Clasby B, Cooper DJ, Czeiter E, Czosnyka M, Dams-O'Connor K, De Keyser V, Diaz-Arrastia R, Ercole A, van Essen TA, Falvey E, Ferguson AR, Figaji A, Fitzgerald M, Foreman B, Gantner D, Gao G, Giacino J, Gravesteijn B, Guiza F, Gupta D, Gurnell M, Haagsma JA, Hammond FM, Hawryluk G, Hutchinson P, van der Jagt M, Jain S, Jain S, Jiang JY, Kent H, Kolias A, Kompanje EJO, Lecky F, Lingsma HF, Maegele M, Majdan M, Markowitz A, McCrea M, Meyfroidt G, Mikolic A, Mondello S, Mukherjee P, Nelson D, Nelson LD, Newcombe V, Okonkwo D, Oresic M, Peul W, Pisica D, Polinder S, Ponsford J, Puybasset L, Raj R, Robba C, Roe C, Rosand J, Schueler P, Sharp DJ, Smielewski P, Stein MB, von Steinbuchel N, Stewart W, Steyerberg EW, Stocchetti N, Temkin N, Tenovuo O, Theadom A, Thomas I, Espin AT, Turgeon AF, Unterberg A, Van Praag D, van Veen E, Verheyden J, Vyvere TV, Wang KKW, Wiegers EJA, Williams WH, Wilson L, Wisniewski SR, Younsi A, Yue JK, Yuh EL, Zeiler FA, Zeldovich M, Zemek R; InTBIR Participants and Investigators. Traumatic brain injury: progress and challenges in prevention, clinical care, and research. Lancet Neurol. 2022 Nov;21(11):1004-1060. doi: 10.1016/S1474-4422(22)00309-X. Epub 2022 Sep 29.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Yakovlev AG, Faden AI. Mechanisms of neural cell death: implications for development of neuroprotective treatment strategies. NeuroRx. 2004 Jan;1(1):5-16. doi: 10.1602/neurorx.1.1.5.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.