UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030746 |
|---|---|
| Receipt number | 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 15:35:42 |
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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
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
95062mn@gmail.com
Sponsor or person
Institute
Department of cardiology, Saku Central Hospital Advanced Care Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035116
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
