UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A multicenter, prospective observational study for the epidemiology of severe trauma
Title of the study (Brief title)	Epidemiology of severe trauma
Region	Japan

Condition
Condition	Trauma
Classification by specialty	Surgery in general Emergency medicine Intensive care medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess epidemiology and pathophysiology of trauma. To establish diagnostic and therapeutic methods for trauma.
Basic objectives2	Others
Basic objectives -Others	Observational study for predicting trauma outcome and evaluating intervention for trauma.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	28-day mortality
Key secondary outcomes	ICU free days Ventilator free days 24-hour amount of blood transfusion Subsequent Acute Respiratory Distress Syndrome (ARDS)

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	Not applicable
Gender	Male and Female
Key inclusion criteria	Injury Severity Score >15
Key exclusion criteria	Out of hospital cardiac arrest
Target sample size	500

Research contact person
Name of lead principal investigator	Satoshi Gando
Organization	Hokkaido University Graduate School of Medicine
Division name	Acute and Critical Care Medicine
Address	N15W7, Kita-ku, Sapporo
TEL	+81-11-706-7377
Email	gando@med.hokudai.ac.jp

Public contact
Name of contact person	Kiyohiko Sato
Organization	Japanese Association for Acute Medicine
Division name	Secretariat
Address	3-3-12, Hongo, Bunkyo-ku, Tokyo
TEL	+81-3-5840-9870
Homepage URL	http://www.jaam.jp/html/jaamforecast/index.html
Email	editorial-jaam@umin.net

Sponsor
Institute	Japanese Association for Acute Medicine
Institute
Department

Funding Source
Organization	Japanese Association for Acute Medicine
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2015 Year 11 Month 15 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 06 Month 05 Day
Anticipated trial start date	2016 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol	http://www.jaam.jp/html/jaamforecast/index.html
Publication of results	Unpublished
URL releasing results
Results
Other related information	A prospective and multi-centered case-control study of severely injured (Injury Severity Score >15) trauma patients. Planned sample size is 500 subjects to enroll from January 1, 20016 for a year. This study gathers information for baseline characteristics, trauma severity, laboratory tests, undergoing interventions and outcomes of trauma subjects.

Management information
Registered date	2015 Year 10 Month 31 Day
Last modified on	2018 Year 05 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022645