UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049943 |
|---|---|
| Receipt number | R000056822 |
| Scientific Title | Study of clinical usefulness of blood biomarkers for mild head injury |
| Date of disclosure of the study information | 2023/04/01 |
| Last modified on | 2024/01/01 14:39:30 |
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Basic information
Public title
Study of clinical usefulness of blood biomarkers for mild head injury
Acronym
Study of clinical usefulness of blood biomarkers for mild head injury
Scientific Title
Study of clinical usefulness of blood biomarkers for mild head injury
Scientific Title:Acronym
Study of clinical usefulness of blood biomarkers for mild head injury
Region
| Japan |
Condition
Condition
mild traumatic brain injury
Classification by specialty
| Neurosurgery | Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The clinical usefulness of two biomarkers, GFAP and UCH-L1 in the blood, as aids in the diagnosis of head injury in patients with suspected mild head injury was investigated by i-STAT (small device) and ARCHITECT/Alinity i ( large equipment).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) In patients with a GCS score of 13 to 15, no neurodegenerative disease or neuropathy, and no history of brain disease within the past 30 days, the lower limit of the two-sided 95% confidence interval of the blood biomarker sensitivity is 85% or higher to determine non-inferiority, when compared with CT examination.
2) In patients with a GCS score of 13 to 15, no neurodegenerative disease or neuropathy, and no history of brain disease within the past 30 days, the negative predictive value for blood biomarkers is more than 97% when the CT positive rate is set to 6%, the same as in the United States.
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| 120 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients over the age of 18
2) Patients presenting with head trauma who underwent a routine head CT scan or who were referred with the results of a routine head CT scan.
3) Patients with a GCS score of 13 to 15 at first visit
4) Patients who had a head CT scan and blood drawn within 12 hours of head injury
5) Patients with cerebral dysfunction (one or more of transient loss of consciousness, amnesia, disorientation, neurological deficit).
Key exclusion criteria
1) Patients participating in therapeutic clinical studies with interventions that impact the outcome of this study (observational studies are acceptable)
2) Patients with unknown time of trauma
3) Patients with a primary diagnosis of ischemic or hemorrhagic stroke at an enrollment center
4) Patients unable to perform venipuncture (skin integrity compromised at venipuncture site, vascular calcification (i.e., IV drug users, advanced atherosclerosis), both upper extremity absent .
5) Patients who are not fit for a CT scanner (eg morbidly obese or claustrophobic)
6) Patients who received a blood transfusion after head trauma prior to blood collection for this study
7) Female patients who are pregnant or breastfeeding
8) Patients without written informed consent
9) If the collected blood specimen is markedly hemolyzed or turbid
10) When the sample volume is significantly insufficient (1 mL or less)
Target sample size
615
Research contact person
Name of lead principal investigator
| 1st name | EIICHI |
| Middle name | |
| Last name | SUEHIRO |
Organization
International University of Health and Welfare, School of Medicine
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, School of Medicine
Division name
Neurosurgery
Zip code
2868520
Address
852 Hatakeda Narita, Chiba 2868520 Japan
TEL
0476355600
Homepage URL
esuehiro@iuhw.ac.jp
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Abbott Japan LLC
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
International University of Health and Welfare Chiba District Ethics Review Board
Address
852 Hatakeda Narita, Chiba 2868520 Japan
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
| 2023 | Year | 04 | 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
| 2022 | Year | 11 | Month | 18 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 31 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Gender, age, date of blood sampling, treatment period and content, evaluation of treatment effect, diagnosis name, GCS score, date of injury, medications, CT image findings, MRI image findings, presence or absence of deterioration, biomarker values
Management information
Registered date
| 2022 | Year | 12 | Month | 29 | Day |
Last modified on
| 2024 | Year | 01 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056822
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| Registered date | File name |
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