UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009787
Receipt number 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 13:09:30

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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 or person

Institute

Yokohama City University Medical 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


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

Value
https://center6.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