UMIN-CTR Clinical Trial

Basic information
Public title	Severity by stress index among trauma patients
Acronym	severity stress index trauma
Scientific Title	Severity by stress index among trauma patients
Scientific Title:Acronym	severity stress index trauma
Region	Japan

Condition
Condition	trauma
Classification by specialty	Emergency medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study was to identify and validate prediction models of severe trauma (ST), needs of damage control operation (DCOP), and massive transfusion (MT) by using SI among trauma patients.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Survival to discharge
Key secondary outcomes	Trauma severity

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	16 years-old <
Age-upper limit	110 years-old >
Gender	Male and Female
Key inclusion criteria	Trauma patient admitted to an emergency room.
Key exclusion criteria	Non trauma patients
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Takeru Middle name Last name Abe
Organization	Yokohama City University
Division name	Medical Center
Zip code	232-0024
Address	4-57 Urafunecho, Minamiku, Yokohama
TEL	045-261-5656
Email	takeru-a@umin.ac.jp

Public contact
Name of contact person	1st name Takeru Middle name Last name Abe
Organization	Yokohama City University
Division name	Medical Center
Zip code	232-0024
Address	4-57 Urafunecho, Minamiku, Yokohama
TEL	045-261-5656
Homepage URL
Email	takeru-a@umin.ac.jp

Sponsor
Institute	Yokohama City University
Institute
Department

Funding Source
Organization	Self funding
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	Advanced Critical Care and Emergency Center, Yokohama City University Medical Center
Address	4-57 Urafunecho, Minamiku, Yokohama City, Kanagawa
Tel	045-261-5656
Email	takeru-a@umin.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 09 Month 05 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
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	Enrolling by invitation
Date of protocol fixation	2016 Year 06 Month 01 Day
Date of IRB	2015 Year 10 Month 01 Day
Anticipated trial start date	2016 Year 06 Month 01 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Now collecting data.

Management information
Registered date	2018 Year 09 Month 05 Day
Last modified on	2019 Year 09 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038808

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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