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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000030746
Receipt No. R000035116
Scientific Title Risk stratification of asymptomatic deep venous thrombosis in preoperative Japanese patients, a retrospective study based on diagnosis using compression ultrasonography
Date of disclosure of the study information 2018/01/10
Last modified on 2018/01/10

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Basic information
Public title Risk stratification of asymptomatic deep venous thrombosis in preoperative Japanese patients, a retrospective study based on diagnosis using compression ultrasonography
Acronym Risk stratification of asymptomatic deep venous thrombosis in preoperative Japanese patients, a retrospective study based on diagnosis using compression ultrasonography
Scientific Title Risk stratification of asymptomatic deep venous thrombosis in preoperative Japanese patients, a retrospective study based on diagnosis using compression ultrasonography
Scientific Title:Acronym Risk stratification of asymptomatic deep venous thrombosis in preoperative Japanese patients, a retrospective study based on diagnosis using compression ultrasonography
Region
Japan

Condition
Condition Deep venous thrombosis
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In recent years, the prevention of venous thromboembolis-m in the perioperative period are important, it has increas-ed that asymptomatic deep venous thrombosis (DVT) is d-etected using ultrasonography in the preoperative evaluat-ion. Generally routine treatment of asymptomatic isolated calf DVT is not need, furthermore not necessary to be detected. On the other hand, it is thought that even asymptom-atic DVT and atherosclerosis have shared risk factors, the concept of a pan-vascular syndrome has been proposed. We aimed to assess prevalence and risk stratification of a-symptomatic DVT in Japanese.
Basic objectives2 Others
Basic objectives -Others To evaluate whether the risk factor of asymptomatic deep venous thrombosis is common with the risk factor of athe-rosclerosis
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Risk stratification of asymptomatic deep venous thrombosis
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 Patients performed compression ultrasonography of deep vein as a screening prior to surgery.
Key exclusion criteria none
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Miki Horigome
Organization Saku Central Hospital Advanced Care Center
Division name Department of cardiology
Zip code
Address 3400-28 Nakagomi Saku Nagano pref, JAPAN
TEL +81-267-62-8181
Email 95062mn@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Miki Horigome
Organization Saku Central Hospital Advanced Care Center
Division name Department of cardiology
Zip code
Address 3400-28 Nakagomi Saku Nagano pref, JAPAN
TEL +81-267-62-8181
Homepage URL
Email 95062mn@gmail.com

Sponsor
Institute Department of cardiology, Saku Central Hospital Advanced Care Center
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 R201510-09
Org. issuing International ID_1 Saku Central Clinic
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 長野厚生連佐久総合病院(長野県)

Other administrative information
Date of disclosure of the study information
2018 Year 01 Month 10 Day

Related information
URL releasing protocol
Publication of results Partially published

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 No longer recruiting
Date of protocol fixation
2016 Year 04 Month 08 Day
Date of IRB
Anticipated trial start date
2016 Year 04 Month 08 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Total 54 patients (6.89%) had asymptomatic DVT and 11 patients had proximal DVT. Risk factors of DVT significantly associated with diabetes mellitus without medication (odds ratio [OR]: 2.54; 95% confidence interval [CI]: 1.07 -6.05), renal dysfunction (eGFR<30) (OR: 4.08; 95% CI: 1.77-9.42), prior DVT (OR: 37.23; 95% CI: 7.04-197.04), a long-term bedridden patient (OR: 7.73; 95% CI: 3.81-15.68), bone fracture (OR: 10.21; 95% CI: 4.53-23.03), and mental disorder (OR: 12.97; 95% CI: 3.26-51.67).

Management information
Registered date
2018 Year 01 Month 10 Day
Last modified on
2018 Year 01 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035116

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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