UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034042 |
|---|---|
| Receipt number | R000038808 |
| Scientific Title | Severity by stress index among trauma patients |
| Date of disclosure of the study information | 2018/09/05 |
| Last modified on | 2020/09/07 21:19:22 |
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Basic information
Public title
Severity by stress index among trauma patients
Acronym
severity stress index trauma
Scientific Title
Severity by stress index among trauma patients
Scientific Title:Acronym
severity stress index trauma
Region
| Japan |
Condition
Condition
trauma
Classification by specialty
| Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to identify and validate prediction models of severe trauma (ST), needs of damage control operation (DCOP), and massive transfusion (MT) by using SI among trauma patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Survival to discharge
Key secondary outcomes
Trauma severity
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
| 16 | years-old | < |
Age-upper limit
| 110 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Trauma patient admitted to an emergency room.
Key exclusion criteria
Non trauma patients
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Takeru |
| Middle name | |
| Last name | Abe |
Organization
Yokohama City University
Division name
Medical Center
Zip code
232-0024
Address
4-57 Urafunecho, Minamiku, Yokohama
TEL
045-261-5656
takeru-a@umin.ac.jp
Public contact
Name of contact person
| 1st name | Takeru |
| Middle name | |
| Last name | Abe |
Organization
Yokohama City University
Division name
Medical Center
Zip code
232-0024
Address
4-57 Urafunecho, Minamiku, Yokohama
TEL
045-261-5656
Homepage URL
takeru-a@umin.ac.jp
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Advanced Critical Care and Emergency Center, Yokohama City University Medical Center
Address
4-57 Urafunecho, Minamiku, Yokohama City, Kanagawa
Tel
045-261-5656
takeru-a@umin.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
| 2018 | Year | 09 | Month | 05 | 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
Completed
Date of protocol fixation
| 2016 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Now collecting data.
Management information
Registered date
| 2018 | Year | 09 | Month | 05 | Day |
Last modified on
| 2020 | Year | 09 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038808
