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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000034928
Receipt No. 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

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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
Email 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
Email gomadofu@wakayama-med.ac.jp

Sponsor
Institute Wakayama Medical University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039828

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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