UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012476 |
|---|---|
| Receipt number | 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 19:04:44 |
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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
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
sangyang@beige.plala.or.jp
Sponsor or person
Institute
Sang Yang Lee
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010886
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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