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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000012476
Receipt No. R000010886
Scientific Title Investigation of the effect of administration period of edoxaban on the venous thromboembolism prophylaxis and the side effect
Date of disclosure of the study information 2013/12/03
Last modified on 2020/12/15

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Basic information
Public title Investigation of the effect of administration period of edoxaban on the venous thromboembolism prophylaxis and the side effect
Acronym Effect of administration period of edoxaban on the VTA and the side effect
Scientific Title Investigation of the effect of administration period of edoxaban on the venous thromboembolism prophylaxis and the side effect
Scientific Title:Acronym Effect of administration period of edoxaban on the VTA and the side effect
Region
Japan

Condition
Condition Fracture of proximal femur
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investihgate the appropriate administration period of edoxaban in older patients with fractures of proximal femur
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To evaluuate the incidence of venous thromboembolism prophylaxis after administration of edoxaban at post-operative days 8 and 15
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 7-day Edoxaban administration
Interventions/Control_2 14-day Edoxaban administration
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
60 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria -Patients with fractures with proximal femur
-Patients whom operation is performed witinh 7 days after fractures
Key exclusion criteria Patinets
-whose body weight is less than 40 kg
-who have renal dysfunction
-who is taking anti platelet agents
-who is taking anticoagulants
-whom anticoagulants is administrated before operation
-whos has high risk of bleeding
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Sang Yang
Middle name
Last name Lee
Organization Kobe University Hospital
Division name Department of Orthopaedic Surgery
Zip code 650-0018
Address 7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Japan
TEL 078-382-5985
Email sangyang@beige.plala.or.jp

Public contact
Name of contact person
1st name Sang Yang
Middle name
Last name Lee
Organization Kobe University Hospital
Division name Department of Orthopaedic Surgery
Zip code 6500018
Address 7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Japan
TEL 078-382-5985
Homepage URL
Email sangyang@beige.plala.or.jp

Sponsor
Institute Sang Yang Lee
Institute
Department

Funding Source
Organization Department of Orthopaedic Surgery, Kobe University Hospital
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 Kobe University Hospital
Address 7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Japan
Tel 078-382-6669
Email chiken@med.kobe-u.ac.jp

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 神戸大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2013 Year 12 Month 03 Day

Related information
URL releasing protocol NA
Publication of results Unpublished

Result
URL related to results and publications NA
Number of participants that the trial has enrolled
Results Deceased
Results date posted
2019 Year 12 Month 10 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics NA
Participant flow NA
Adverse events NA
Outcome measures NA
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2013 Year 12 Month 03 Day
Date of IRB
2013 Year 12 Month 01 Day
Anticipated trial start date
2013 Year 12 Month 03 Day
Last follow-up date
2017 Year 03 Month 31 Day
Date of closure to data entry
2017 Year 03 Month 31 Day
Date trial data considered complete
2017 Year 03 Month 31 Day
Date analysis concluded
2017 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2013 Year 12 Month 03 Day
Last modified on
2020 Year 12 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010886

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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