UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037249 |
|---|---|
| Receipt number | R000042402 |
| Scientific Title | Repeated measurement of quick sequential organ failure assessment score to predict in-hospital mortality among patients with trauma: an analysis of nationwide registry data |
| Date of disclosure of the study information | 2019/07/03 |
| Last modified on | 2020/06/27 00:12:36 |
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Basic information
Public title
Repeated measurement of quick sequential organ failure assessment score to predict in-hospital mortality among patients with trauma: an analysis of nationwide registry data
Acronym
Repeated measurement of qSOFA score to predict in-hospital mortality among patients with trauma
Scientific Title
Repeated measurement of quick sequential organ failure assessment score to predict in-hospital mortality among patients with trauma: an analysis of nationwide registry data
Scientific Title:Acronym
Repeated measurement of qSOFA score to predict in-hospital mortality among patients with trauma
Region
| Japan |
Condition
Condition
trauma
Classification by specialty
| Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We sought to determine whether the repeated measurements of the qSOFA score improves the discriminative ability of in-hospital mortality of patients with trauma.
Basic objectives2
Others
Basic objectives -Others
To evaluate the clinical prediction rule
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
in-hospital mortality
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Included patients were aged >18 years old and transferred to hospitals from the scenes of injury.
Key exclusion criteria
transferred from other hospitals
transferred by physician-staffed cars or helicopters
prehospital cardiopulmonary arrest
burn injury
Target sample size
90000
Research contact person
Name of lead principal investigator
| 1st name | Kyohei |
| Middle name | |
| Last name | Miyamoto |
Organization
Wakayama Medical University
Division name
Department of Emergency and Critical Care Medicine
Zip code
6410012
Address
811-1 Kimiidera, Wakayama-City, Wakayama, 641-8509, JAPAN
TEL
0734410603
gomadofu@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Kyohei |
| Middle name | |
| Last name | Miyamoto |
Organization
Wakayama Medical University
Division name
Department of Emergency and Critical Care Medicine
Zip code
6410012
Address
811-1 Kimiidera, Wakayama-City, Wakayama, 641-8509, JAPAN
TEL
0734410603
Homepage URL
gomadofu@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
Wakayama Medical University
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
IRB of Wakayama Medical University
Address
811-1 Kimiidera, Wakayama-City, Wakayama, 641-8509, JAPAN
Tel
0734410603
gomadofu@wakayama-med.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
| 2019 | Year | 07 | Month | 03 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/full/10.1002/ams2.532
Number of participants that the trial has enrolled
90974
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
| 2019 | Year | 06 | Month | 27 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 27 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 27 | Day |
Last follow-up date
| 2019 | Year | 06 | Month | 27 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective study using registry of japan trauma data bank
Management information
Registered date
| 2019 | Year | 07 | Month | 03 | Day |
Last modified on
| 2020 | Year | 06 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042402
