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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002225
Receipt No. R000002694
Scientific Title Insults, body responses, and organ dysfunction in trauma
Date of disclosure of the study information 2009/07/25
Last modified on 2009/07/20

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Basic information
Public title Insults, body responses, and organ dysfunction in trauma
Acronym Trauma, coagulation and fibrinolysis, MODS
Scientific Title Insults, body responses, and organ dysfunction in trauma
Scientific Title:Acronym Trauma, coagulation and fibrinolysis, MODS
Region
Japan

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

Objectives
Narrative objectives1 To investigate the relationship between coagulofibrinolytic responses and organ dysfunction syndrome in trauma patients
Basic objectives2 Others
Basic objectives -Others Pathophysiology of coagulation and fibrinolytic responses following trauma
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Relationship between coagulofibrinolytic responses and organ dysfunction
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
15 years-old <=
Age-upper limit
90 years-old >
Gender Male and Female
Key inclusion criteria Severe trauma including more than 1 injury with AIS >=3.
Key exclusion criteria liver chirrosis, treating with anticoagulants
Target sample size 50

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 N17W5, Kita-ku, Sapporo
TEL 011-706-7377
Email

Public contact
Name of contact person
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 N17W5, Kita-ku, Sapporo
TEL 011-706-7377
Homepage URL http://www.med.hokudai.ac.jp/~qq-w/
Email gando@med.hokudai.ac.jp

Sponsor
Institute Hokkaido University Graduate School of Medicine, Department of Anesthesiology and critical care medicine, Division of Acute and Critical Care Medicine
Institute
Department

Funding Source
Organization Grant 2007-19391456
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor None
Name of secondary funder(s) None

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2009 Year 07 Month 25 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 Completed
Date of protocol fixation
2003 Year 05 Month 23 Day
Date of IRB
Anticipated trial start date
2003 Year 05 Month 01 Day
Last follow-up date
2008 Year 03 Month 01 Day
Date of closure to data entry
2008 Year 03 Month 01 Day
Date trial data considered complete
2008 Year 03 Month 01 Day
Date analysis concluded
2010 Year 12 Month 01 Day

Other
Other related information Measurement variables: parameters related to coagulation and fibrinolysis, and inflammation.

Management information
Registered date
2009 Year 07 Month 20 Day
Last modified on
2009 Year 07 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002694

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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