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

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 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

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

Value
https://center6.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