UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019588 |
|---|---|
| Receipt number | R000022645 |
| Scientific Title | A multicenter, prospective observational study for the epidemiology of severe trauma |
| Date of disclosure of the study information | 2015/11/15 |
| Last modified on | 2018/05/17 05:18:19 |
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Basic information
Public title
A multicenter, prospective observational study for the epidemiology of severe trauma
Acronym
Epidemiology of severe trauma
Scientific Title
A multicenter, prospective observational study for the epidemiology of severe trauma
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Satoshi Gando |
Organization
Hokkaido University Graduate School of Medicine
Division name
Acute and Critical Care Medicine
Zip code
Address
N15W7, Kita-ku, Sapporo
TEL
+81-11-706-7377
gando@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kiyohiko Sato |
Organization
Japanese Association for Acute Medicine
Division name
Secretariat
Zip code
Address
3-3-12, Hongo, Bunkyo-ku, Tokyo
TEL
+81-3-5840-9870
Homepage URL
http://www.jaam.jp/html/jaamforecast/index.html
editorial-jaam@umin.net
Sponsor or person
Institute
Japanese Association for Acute Medicine
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
http://www.jaam.jp/html/jaamforecast/index.html
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
Completed
Date of protocol fixation
| 2015 | Year | 06 | Month | 05 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022645
