UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010309
Receipt number R000012064
Scientific Title The effect of enoxaparin with cilostazol for prevention of venous thromboembolism after total knee and hip arthroplasty
Date of disclosure of the study information 2013/03/23
Last modified on 2015/06/13 12:54:22

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

The effect of enoxaparin with cilostazol for prevention of venous thromboembolism after total knee and hip arthroplasty

Acronym

The effect of cilostazol for prevention of venous thromboembolism after arthroplasty

Scientific Title

The effect of enoxaparin with cilostazol for prevention of venous thromboembolism after total knee and hip arthroplasty

Scientific Title:Acronym

The effect of cilostazol for prevention of venous thromboembolism after arthroplasty

Region

Japan


Condition

Condition

deep-vein thrombosis

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

his study is conducted the effect of enoxaparin with cilostazol for prevention of venous thromboembolism after total knee and hip arthroplasty

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The next day of surgery is defined as day 1.Deep-vein thrombosis is assessed on day 14 by mean of ultrasonography

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Pseudo-randomization


Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Medicine

Interventions/Control_1

Patients are assigned to receive twice-daily injection of enoxaparin sodium, in a 20-mg dose. Enoxaparin is initiated 24 to 36 hours after surgery until day 14.

Interventions/Control_2

Patients are assigned to receive twice-daily injection of enoxaparin sodium, in a 20-mg dose. Enoxaparin is initiated 24 to 36 hours after surgery until day 14. And patients are also received once-daily oral cilostazol, in a 50-mg tablet 3 days before surgery , in two 50-mg tablets 2 days before surgery and are given two 50-mg tablets again 24 to 36 hours after wound closure. Then patients are received twice-daily cilostazol, in a 100-mg tablet 2 days after surgery until day 14.

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 are eligible for the study if they were 20 years of age or older and are scheduled for total knee arthroplasty or total hip arthroplasty.

Key exclusion criteria

We exclude patients with active bleeding or a high risk of bleeding that contraindicated the use of low-molecular-weight heparin and patients with any contraindication to the
use of enoxaparin or cilostazol.
Other exclusion criteria include conditions clinically significant compromised renal function, acute endocarditis, heparin induced thrombocytopenia, congestive heart failure, and pregnancy or breast-feeding.

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kato yosiharu

Organization

Tokyo Women's Medical University

Division name

Department of Orthopedic surgery

Zip code


Address

8-1 Kawada-cho Shinjuku-ku Tokyo

TEL

03-3353-8111

Email



Public contact

Name of contact person

1st name
Middle name
Last name morita yuji

Organization

Tokyo Women's Medical University

Division name

Department of Orthopedic surgery

Zip code


Address

8-1 Kawada-cho Shinjuku-ku Tokyo

TEL

03-3353-8111

Homepage URL


Email

morita@ort.twmu.ac.jp


Sponsor or person

Institute

Department of orthopedic surgery, Tokyo women's medical university

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan


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



Other administrative information

Date of disclosure of the study information

2013 Year 03 Month 23 Day


Related information

URL releasing protocol


Publication of results

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

2011 Year 10 Month 13 Day

Date of IRB


Anticipated trial start date

2011 Year 11 Month 01 Day

Last follow-up date

2014 Year 01 Month 29 Day

Date of closure to data entry

2015 Year 04 Month 30 Day

Date trial data considered complete

2015 Year 04 Month 30 Day

Date analysis concluded

2015 Year 04 Month 30 Day


Other

Other related information



Management information

Registered date

2013 Year 03 Month 23 Day

Last modified on

2015 Year 06 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012064


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name