UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000046759
Receipt number R000053345
Scientific Title Development of a patient prognosis prediction model using prehospital information and emergency room data
Date of disclosure of the study information 2022/01/28
Last modified on 2023/07/31 09:13:26

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Basic information

Public title

Development of a patient prognosis prediction model using prehospital information and emergency room data

Acronym

Development of a patient prognosis prediction model using prehospital information and emergency room data

Scientific Title

Development of a patient prognosis prediction model using prehospital information and emergency room data

Scientific Title:Acronym

Development of a patient prognosis prediction model using prehospital information and emergency room data

Region

Japan


Condition

Condition

All patients transported to the emergency room at the Collaborative Research Facility

Classification by specialty

Emergency medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

In addition to investigating the actual conditions of patients who receive emergency care, we will examine the degree to which the severity assessment at the time of emergency care is consistent with the actual severity, and the degree to which there are discrepancies.

Basic objectives2

Others

Basic objectives -Others

To develop an appropriate risk classification and prognostic model for emergency patients based on prehospital information.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Agreement between the severity reported by the emergency services and the actual severity

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

1 years-old <=

Age-upper limit

100 years-old >=

Gender

Male and Female

Key inclusion criteria

All patients who were transported to the emergency room of the collaborating institutions from the date when each institution introduced NSER to March 2024 will be included.

Key exclusion criteria

Patients who have expressed their refusal to allow their clinical data to be used in research according to the requirements of the opt-out (but not if their personal information has already been removed and they cannot be identified). The opt-out will be available in the emergency room of each collaborating institution, on the institution's webpage, and on TXP Medical's webpage.

Target sample size

50000


Research contact person

Name of lead principal investigator

1st name KEIBUN
Middle name
Last name LIU

Organization

The Prince Charles Hospital

Division name

Critical Care Research Group

Zip code

4032

Address

627 Rode Rd, Chermside QLD 4032

TEL

080-4790-7701

Email

keiliu0406@gmail.com


Public contact

Name of contact person

1st name KEIBUN
Middle name
Last name LIU

Organization

The Prince Charles Hospital

Division name

Critical Care Research Group

Zip code

4032

Address

627 Rode Rd, Chermside QLD 4032

TEL

080-4790-7701

Homepage URL


Email

keiliu0406@gmail.com


Sponsor or person

Institute

TXP Medical

Institute

Department

Personal name



Funding Source

Organization

NA

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

TXP Medical Co. Ltd.

Address

252, South Research Building, University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan

Tel

03-5615-8433

Email

keibun.liu@txpmedical.com


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

2022 Year 01 Month 28 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled

10000

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

No longer recruiting

Date of protocol fixation

2022 Year 01 Month 26 Day

Date of IRB

2022 Year 01 Month 26 Day

Anticipated trial start date

2022 Year 01 Month 28 Day

Last follow-up date

2024 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Retrospective study


Management information

Registered date

2022 Year 01 Month 28 Day

Last modified on

2023 Year 07 Month 31 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053345