Moderate Traumatic Brain InjuryNCT06537713
Diagnostic Role of Serum Testican and Ubiquitin Levels in Patients With Head Trauma
An observational study of Moderate Traumatic Brain Injury and Testican-1, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Moderate Traumatic Brain Injury, Testican-1, Ubiquitin
- What is being tested?
- Testican-1
- How many people
- 89 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2020to 30 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- being over 18 years old
- having a GCS score between 9 and 13
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kanuni SUltan Suleyman Training and Research Hospital
Istanbul, Küçükçekmece, 34303
About this study
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.
Read the 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.
- Conditions
- Moderate Traumatic Brain Injury, Testican-1, Ubiquitin
- Being tested
- Testican-1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Testican-1Diagnostic test
Also called Ubiquitin
Testican-1 and ubiquitin can serve as early indicators for diagnosing worsening clinical course and mortality in patients with moderate traumatic brain injury.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | The control group consisted of healthy individuals without any disease who voluntarily participated in the study. Receives: 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. Receives: Diagnostic Test: Testican-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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 (+)
We investigated the diagnostic value of biomarkers in detecting pathology on brain CT in patients with moderate traumatic brain injury.
Measured: The study was conducted with blood samples taken at the time of admission.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2024
- Study start1 Oct 2020
- Primary completion31 Mar 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Moderate Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ramiz Yazıcı, Kanuni Sultan Suleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06537713
- Sponsor's protocol ID
- 2019/159
- Status last verified
- Jul 2024
- First submitted
- 31 Jul 2024
- Last updated
- 5 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It can be shared upon reaching the corresponding author.
Publications
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.
PubMed 36183712Hossain 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.
PubMed 37851061Shultz 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.
PubMed 36482407Hossain 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.
PubMed 38510630Silvestro 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.
PubMed 38397046Kim 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.
PubMed 38585027Iseki 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.
PubMed 22199127Yakovlev 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.
PubMed 15717003Tongaonkar 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.
PubMed 10848595Azar 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.
PubMed 28508357Liu 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.
PubMed 20384815Welch 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.
PubMed 26467555Papa 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.
PubMed 22673263Mondello 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.
PubMed 27319802
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Role of Serum Testican and Ubiquitin Levels in Patients With Head Trauma
- ClinicalTrials.gov ID
- NCT06537713
- Acronym / sponsor ID
- 2019/159
- Conditions
- Moderate Traumatic Brain Injury, Testican-1, Ubiquitin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 5 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | – | Diagnostic Test: Testican-1The control group consisted of healthy individuals without any disease who voluntarily participated in the study. |
| Patients Group | – | Diagnostic Test: Testican-1The study specifically included patients over 18 years of age with moderate TBI (GCS: 9-13) who provided informed consent. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- being over 18 years old
- having a GCS score between 9 and 13
Key exclusion criteria (8 listed)
- under 18 years of age
- had missing data
- were pregnant
- had neurodegenerative disease
- had Central Nervous System (CNS) infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Testican-1Also: UbiquitinTestican-1 and ubiquitin can serve as early indicators for diagnosing worsening clinical course and mortality in patients with moderate traumatic brain injury. | Diagnostic test | Control Group, Patients Group |
Primary outcome
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
1 secondary outcome
ROC curve analysis for the prediction of intraparenchymal pathology (+)
Time frame: The study was conducted with blood samples taken at the time of admission.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2024.
- Background: PubMed 36183712Maas 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.
- Background: PubMed 37851061Hossain 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.
- Background: PubMed 36482407Shultz 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.
- Background: PubMed 38510630Hossain 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.
- Background: PubMed 38397046Silvestro 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.
- Background: PubMed 38585027Kim 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.
- Background: PubMed 22199127Iseki 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.
- Background: PubMed 15717003Yakovlev 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.
- Background: PubMed 10848595Tongaonkar 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.
- Background: PubMed 28508357Azar 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.
- Background: PubMed 20384815Liu 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.
- Background: PubMed 26467555Welch 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.
- Individual participant dataSharing planned: No. It can be shared upon reaching the corresponding author.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Moderate Traumatic Brain Injury and Testican-1, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06537713, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2024; AzTrials last refreshed its copy on 8 Nov 2026.