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

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

6410012

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 Wakayama Medical University

Address

811-1 Kimiidera, Wakayama-City, Wakayama, 641-8509, JAPAN

Tel

0734410603

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name