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

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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039828


Research Plan
Registered date File name

Research case data specifications
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Research case data
Registered date File name