UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017220 |
|---|---|
| Receipt number | R000019974 |
| Scientific Title | Laboratory monitoring and the anti-coagulant effect of Edoxaban after total knee arthroplasty |
| Date of disclosure of the study information | 2015/04/22 |
| Last modified on | 2020/10/26 19:53:44 |
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Basic information
Public title
Laboratory monitoring and the anti-coagulant effect of Edoxaban after total knee arthroplasty
Acronym
Laboratory monitoring and the anti-coagulant effect of Edoxaban
Scientific Title
Laboratory monitoring and the anti-coagulant effect of Edoxaban after total knee arthroplasty
Scientific Title:Acronym
Laboratory monitoring and the anti-coagulant effect of Edoxaban
Region
| Japan |
Condition
Condition
The patients who will be performed TKA/THA
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the anti-coagulant effect, safety, and the correlation with verious markers of Edoxaban usage for the patients after TKA/THA.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
incidence of DVT
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Edoxaban usage (15mg)
Interventions/Control_2
Edoxaban usage (30mg)
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The patients who will be performed TKA/THA
20-75 years old
Key exclusion criteria
bleeding risks
bleeding tendency
bleeding history
uncontrollable hypertension
Operation history within 30 days
uncontrollable DM
low body weight less than 50 kg
Renal failure
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomohiro Onodera |
Organization
Hokkaido University, Graduate School of Medicine
Division name
Department of Orthopaedic Surgery
Zip code
Address
Kita 15, Nishi 7, Kita-ku, Sapporo
TEL
011-706-5935
tomozou@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomohiro Onodera |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Orthopaedic Surgery
Zip code
Address
Kita 15, Nishi 7, Kita-ku, Sapporo
TEL
011-706-5935
Homepage URL
tomozou@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University
Institute
Department
Personal name
Funding Source
Organization
Hokkaido University
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2015 | Year | 04 | Month | 22 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
| 2012 | Year | 05 | Month | 29 | Day |
Date of IRB
| 2012 | Year | 05 | Month | 29 | Day |
Anticipated trial start date
| 2012 | Year | 05 | Month | 29 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 04 | Month | 21 | Day |
Last modified on
| 2020 | Year | 10 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019974
