UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056410 |
|---|---|
| Receipt number | R000064398 |
| Scientific Title | Quantitative assessment of sports-related concussion using blood biomarkers |
| Date of disclosure of the study information | 2025/03/01 |
| Last modified on | 2026/05/24 12:20:41 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Quantitative assessment of sports-related concussion using blood biomarkers
Acronym
Quantitative assessment of sports-related concussion using blood biomarkers
Scientific Title
Quantitative assessment of sports-related concussion using blood biomarkers
Scientific Title:Acronym
Quantitative assessment of sports-related concussion using blood biomarkers
Region
| Japan |
Condition
Condition
sports-related concussion
Classification by specialty
| Neurosurgery | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to diagnose and assess the severity of sports related concussion using the values of blood biomarkers. Until now, blood biomarkers, imaging diagnosis, and symptoms of sports related concussion have been separately studied. With this method, the diversity of sports related concussion has led to inconsistent research results, and it has been difficult to comprehensively determine the diagnosis and severity of sports related concussion, making it difficult to apply to clinical practice. In this study, brain damage is quantitatively evaluated using blood biomarkers. Structural changes in brain damage are evaluated using MRI. Symptoms due to brain damage are evaluated using SCAT5. In this study, by examining the correlation between these three evaluation items, it is possible to simply evaluate pathology and symptoms [SCAT5, MRI] numerically [blood biomarkers] without the influence of various pathologies and symptoms, and obtain results that are directly useful in clinical practice.
Basic objectives2
Others
Basic objectives -Others
In recent years, attention has been focused on how to respond to sports-related concussions in the wake of head and neck trauma accidents during judo and the mandatory introduction of martial arts in junior high schools. In particular, accurate diagnosis and response to sports-related concussions are important to prevent sports head injuries from becoming more severe. Sports-related concussions can be evaluated from multiple angles by examining not only the values of blood biomarkers, but also the correlation with MRI image findings and SCAT5 results. Using blood biomarkers as indicators, research results are expected to enable appropriate responses to sports-related concussions.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relationship between concussion (diagnosed by SCAT5) and blood biomarkers values (GFAP, UCH-L1)
Key secondary outcomes
Relationship between organic abnormalities (diagnosed by MRI) and blood biomarker values (GFAP, UCH-L1)
Relationship between time to return to competition and blood biomarker values (GFAP, UCH-L1)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients aged 20 years or older who suffered a head injury during a sporting event between February 1, 2025 and January 31, 2027, were aware of symptoms of a concussion, and visited the research institution's concussion outpatient clinic within 24 hours of the injury.
Key exclusion criteria
Patients with unknown time of trauma
Patients with a primary diagnosis of ischemic or hemorrhagic stroke at the enrollment site
Patients unable to perform venipuncture (compromised skin integrity at the venipuncture site, vascular calcification (i.e., IV drug users, advanced atherosclerosis), missing both upper limbs (congenital or amputee))
Patients unable to enter the CT scanner (e.g., morbid obesity or claustrophobia)
Patients who received a blood transfusion after head trauma and before blood collection for this study
Pregnant or breastfeeding female patients
Patients for whom written consent could not be obtained
Severely hemolyzed or turbid blood sample
Severely insufficient sample volume (1mL or less)
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Eiichi |
| Middle name | |
| Last name | Suehiro |
Organization
International University of Health and Welfare Narita Hospital
Division name
Neurosurgery
Zip code
286-8520
Address
852 Hatakeda Narita Chiba
TEL
0476355600
esuehiro@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | Eiichi |
| Middle name | |
| Last name | Suehiro |
Organization
International University of Health and Welfare Narita Hospital
Division name
Neurosurgery
Zip code
286-8520
Address
852 Hatakeda Narita Chiba
TEL
0476355600
Homepage URL
esuehiro@iuhw.ac.jp
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
Eiichi Suehiro
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
International University of Health and Welfare
Address
852 Hatakeda Narita Chiba
Tel
0476355600
esuehiro@iuhw.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 03 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2024 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 21 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1) Basic patient information: age, sex, medical history, diagnosis, time of injury
2) Findings at time of admission: neurological findings (SCAT), head MRI (DTI)
3) Blood tests at time of admission (blood biomarkers measured using i-STAT using residual samples from tests required for treatment)
4) Timing of return to competition as an outpatient
Management information
Registered date
| 2024 | Year | 12 | Month | 10 | Day |
Last modified on
| 2026 | Year | 05 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064398
