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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000038278
Receipt No. R000043632
Scientific Title Vein echogenic findings of lower limbs and hemostatic function test with field of tsunami stricken area
Date of disclosure of the study information 2019/10/11
Last modified on 2019/10/11

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Basic information
Public title Vein echogenic findings of lower limbs and hemostatic function test with field of tsunami stricken area
Acronym Deep vein thrombosis screening in the area affected by the tsunami
Scientific Title Vein echogenic findings of lower limbs and hemostatic function test with field of tsunami stricken area
Scientific Title:Acronym Deep vein thrombosis screening in the area affected by the tsunami
Region
Japan

Condition
Condition deep vein thrombus
Classification by specialty
Cardiology Hematology and clinical oncology Geriatrics
Laboratory medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 deep vein thrombus in Disaster Area
Basic objectives2 Others
Basic objectives -Others Reduction of disaster-related death
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Transition of deep vein thrombosis in the area affected by the tsunami from 2 to 5 years after the Great East Japan Earthquake
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Residents of Tsunami Afflicted Area
Key exclusion criteria Those who can not obtain consent
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name Osamu
Middle name
Last name Yamamura
Organization Faculty of Medical Science, University of Fukui
Division name Deparement of Community Medicine
Zip code 910-1193
Address 23-3, Shimoaizuki, Matsuoka, Eiheiji, Yoshida, Fukui
TEL 0776-61-3111
Email kapi@u-fukui.ac.jp

Public contact
Name of contact person
1st name Osamu
Middle name
Last name Yamamura
Organization Faculty of Medical Science, University of Fukui
Division name Deparement of Community Medicine
Zip code 910-1193
Address 23-3, Shimoaizuki, Matsuoka, Eiheiji, Yoshida, Fukui
TEL 0776-61-3111
Homepage URL
Email kapi@u-fukui.ac.jp

Sponsor
Institute Faculty of Medical Science, University of Fukui
Institute
Department

Funding Source
Organization Japan Society of Promotion of Science
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Fukui University School of Medicine Ethics Committee
Address 23-3, Shimoaizuki, Matsuoka, Eiheiji, Yoshida, Fukui
Tel 0776-61-8529
Email chiken@ml.u-fukui.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
2019 Year 10 Month 11 Day

Related information
URL releasing protocol No URL
Publication of results Partially published

Result
URL related to results and publications No URL
Number of participants that the trial has enrolled 1130
Results The DVT detection rate of subjects during the period increased every year (2-5 years after the disaster)
Results date posted
2019 Year 10 Month 11 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics Victim
Participant flow Excludes those with incomplete questionnaire
Adverse events None
Outcome measures Evaluation for DVT
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Main results already published
Date of protocol fixation
2012 Year 08 Month 08 Day
Date of IRB
2012 Year 07 Month 01 Day
Anticipated trial start date
2012 Year 09 Month 15 Day
Last follow-up date
2015 Year 10 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Descriptive epidemiology research
Case control study
Cross-sectional research

Management information
Registered date
2019 Year 10 Month 11 Day
Last modified on
2019 Year 10 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043632

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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