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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010309
Receipt No. 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

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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
Institute Department of orthopedic surgery, Tokyo women's medical university
Institute
Department

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
URL(English) https://upload.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


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