UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034928 |
|---|---|
| Receipt number | R000039828 |
| Scientific Title | Prehospital quick sequential organ failure assessment score for predicting in-hospital mortality among patients with trauma: an analysis of nationwide registry data |
| Date of disclosure of the study information | 2018/11/28 |
| Last modified on | 2019/06/26 14:10:47 |
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Basic information
Public title
Prehospital quick sequential organ failure assessment score for predicting in-hospital mortality among patients with trauma: an analysis of nationwide registry data
Acronym
The association between the prehospital qSOFA score and in-hospital mortality in patients with trauma
Scientific Title
Prehospital quick sequential organ failure assessment score for predicting in-hospital mortality among patients with trauma: an analysis of nationwide registry data
Scientific Title:Acronym
The association between the prehospital qSOFA score and in-hospital mortality in patients with trauma
Region
| Japan |
Condition
Condition
Trauma
Classification by specialty
| Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the discriminative ability of the prehospital qSOFA score for in-hospital mortality in 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
two-days mortality
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
trauma patients aged 18 and older who were registered between 2004 and 2016 in Japan Trauma Daba Bank
Key exclusion criteria
We excluded patients who had been transferred from other hospitals, presented with burn injuries, were <18 years old or exhibited cardiopulmonary arrest on the scene, as well as those with missing data for age, discharge outcome or vital signs at the scene, including the respiratory rate (RR), Japan Coma Scale (JCS) score or systolic blood pressure (SBP).
Target sample size
40000
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
6418509
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
6418509
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 WMU
Address
Wakayama
Tel
0734410603
eccm@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
| 2018 | Year | 11 | Month | 28 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.ajemjournal.com/article/S0735-6757(19)30156-1/fulltext
Number of participants that the trial has enrolled
Results
Objective
The quick sequential organ failure assessment (qSOFA) score is calculated from three variables measured at the scene of trauma: systolic blood pressure, respiratory rate and consciousness. This study aimed to evaluate the discriminative ability of the prehospital qSOFA score for in-hospital mortality in patients with trauma.
Methods
This retrospective multicenter study used data from 42,722 patients with trauma included in a Japanese nationwide trauma registry. All included patients were aged >=18？years old and transferred to hospitals from the scenes of injury. The primary outcome was in-hospital mortality.
Results
The included patients had a mean age of 59.4？+-？21.5？years and a male predominance (63%). In-hospital mortality occurred in 2612 patients (6%), while 2-day mortality occurred in 1189 of 42,339 patients (3%). When patients were stratified by qSOFA scores, in-hospital mortality rates of 0.9% (105/11783), 5% (941/17839), 12% (1280/11132) and 15% (286/1968) were associated with qSOFA scores of 0, 1, 2 and 3, respectively (P？<？0.0001 for trend). The area under the receiver operating characteristics curve of the qSOFA score for in-hospital mortality was 0.70 (95% confidence interval: 0.69-0.71). A qSOFA score cutoff value >=1 yielded a sensitivity and specificity of 0.96 and 0.29, respectively, overall, and a sensitivity of 0.99 in patients younger than 65？years.
Conclusions
The prehospital qSOFA score was strongly associated with in-hospital mortality in patients with trauma. A prehospital qSOFA score cutoff of >=1 can be used to identify patients at a very low risk of death, especially in younger age groups.
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
| 2018 | Year | 09 | Month | 19 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 26 | Day |
Anticipated trial start date
| 2018 | Year | 11 | Month | 28 | Day |
Last follow-up date
| 2018 | Year | 11 | Month | 28 | Day |
Date of closure to data entry
| 2018 | Year | 11 | Month | 28 | Day |
Date trial data considered complete
| 2018 | Year | 11 | Month | 28 | Day |
Date analysis concluded
Other
Other related information
We analyze the data from the Japan Trauma Data Bank retrospectively.
Management information
Registered date
| 2018 | Year | 11 | Month | 18 | Day |
Last modified on
| 2019 | Year | 06 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039828
