UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Risk stratification of asymptomatic deep venous thrombosis in preoperative Japanese patients, a retrospective study based on diagnosis using compression ultrasonography
Title of the study (Brief title)	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	Miki Horigome
Organization	Saku Central Hospital Advanced Care Center
Division name	Department of cardiology
Address	3400-28 Nakagomi Saku Nagano pref, JAPAN
TEL	+81-267-62-8181
Email	95062mn@gmail.com

Public contact
Name of contact person	Miki Horigome
Organization	Saku Central Hospital Advanced Care Center
Division name	Department of cardiology
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)

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2016 Year 04 Month 08 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
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