UMIN-CTR Clinical Trial

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

Contact us.