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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009787
Receipt No. R000011461
Scientific Title The utility of endothelial function assessed by EndoPAT2000 in estimating the risk of venous thromboembolism after lower extremity arthroplasty
Date of disclosure of the study information 2013/01/22
Last modified on 2013/08/12

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Basic information
Public title The utility of endothelial function assessed by EndoPAT2000 in estimating the risk of venous thromboembolism after lower extremity arthroplasty
Acronym The utility of endothelial function assessed by EndoPAT2000 in estimating the risk of venous thromboembolism after lower extremity arthroplasty
Scientific Title The utility of endothelial function assessed by EndoPAT2000 in estimating the risk of venous thromboembolism after lower extremity arthroplasty
Scientific Title:Acronym The utility of endothelial function assessed by EndoPAT2000 in estimating the risk of venous thromboembolism after lower extremity arthroplasty
Region
Japan

Condition
Condition osteoarthritis
Classification by specialty
Medicine in general Cardiology Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to investigate the predictive value of reactive hyperemia peripheral arterial tonometry (RH-PAT) for deep venous thrombosis (DVT) after lower extremity arthroplasty.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The Occurrence of Deep venous thrombosis (DVT) after lower extremity arthroplasty.
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 The osteoarthritis patients who are scheduled to undergo total knee or hip arthroplasty are included in this study.
Key exclusion criteria The following patients are excluded; patients who have venous thromboembolism, malignancy, systemic inflammatory disease, and congenital coagulation disorder.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kiyoshi Hibi
Organization Yokohama City University Medical Center
Division name Division of Cardiology
Zip code
Address 4-57 Urafune-cho, Minami-ku, Yokohama, Kanagawa, Japan
TEL 045-261-5656
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hiroyuki Suzuki
Organization Yokohama City University Medical Center
Division name Division of Cardiology
Zip code
Address 4-57 Urafune-cho, Minami-ku, Yokohama, Kanagawa, Japan
TEL 045-261-5656
Homepage URL
Email hamayokoyokoichi@yahoo.co.jp

Sponsor
Institute Yokohama City University Medical 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 NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 横浜市立大学附属市民総合医療センター(神奈川県)

Other administrative information
Date of disclosure of the study information
2013 Year 01 Month 22 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 Completed
Date of protocol fixation
2010 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 02 Month 28 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This is a prospective observational study of consecutive osteoarthritis patients who underwent total knee or hip arthroplasty. To evaluate endothelial function, RH-PAT index (RHI) was measured using Endo-PAT 2000 the day before surgery. Ultrasonography or venography was performed before and after surgery (postoperative day 7 to 14) to evaluate the presence of DVT.

Management information
Registered date
2013 Year 01 Month 15 Day
Last modified on
2013 Year 08 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011461

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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