UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038278 |
|---|---|
| Receipt number | 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 19:46:14 |
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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
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
kapi@u-fukui.ac.jp
Sponsor or person
Institute
Faculty of Medical Science, University of Fukui
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043632
