UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000034842 |
|---|---|
| Receipt number | R000039734 |
| Scientific Title | Efficacy of intravenous tranexamic acid administration for open wedge distal tuberosity osteotomy (OWDTO):a randomized control trial |
| Date of disclosure of the study information | 2018/11/10 |
| Last modified on | 2019/05/16 17:47:06 |
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Basic information
Public title
Efficacy of intravenous tranexamic acid administration for open wedge distal tuberosity osteotomy (OWDTO):a randomized control trial
Acronym
Efficacy of intravenous tranexamic acid administration for open wedge distal tuberosity osteotomy (OWDTO):a randomized control trial
Scientific Title
Efficacy of intravenous tranexamic acid administration for open wedge distal tuberosity osteotomy (OWDTO):a randomized control trial
Scientific Title:Acronym
Efficacy of intravenous tranexamic acid administration for open wedge distal tuberosity osteotomy (OWDTO):a randomized control trial
Region
| Japan |
Condition
Condition
Osteoarthritis of the knee,avascular necrosis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate whether intravenous tranexamic acid administration can reduce blood loss after open wedge distal tuberosity osteotomy(OWDTO).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The volume of perioperative blood loss measured using the calculated blood volume and change in hemoglobin from preoperative to postoperative day 3
Key secondary outcomes
1. The volume of perioperative blood loss measured using the calculated blood volume and change in hemoglobin from preoperative to postoperative day 7
2. Total postoperative drainage volume
3. Knee circumference at postoperative day 7
4. Complication
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Intravenous tranexamic acid group:
Patients received 1000 mg of tranexamic acid administered intravenously just before skin incision and 6 hours after the first intravenous administration of tranexamic acid.
Interventions/Control_2
Controll group:
No administration of tranexiamic acid
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 undergoing unilateral open wedge distal tuberosity osteotomy(OWDTO)
Key exclusion criteria
1.Patients scheduled for Hybrid Closed wedge high tibial osteotomy combined with implant removal.
2.Patients who had allergy for tranexiamic acid
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takuya Iseki |
Organization
Hyogo College of Medicine
Division name
Orthopaedic Surgery
Zip code
Address
Mukogawacho 1-1, Nishinomiya, Hyogo, Japan
TEL
0798456111
takuyaiseki@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takuya Iseki |
Organization
Hyogo College of Medicine
Division name
Orthopaedic Surgery
Zip code
Address
Mukogawacho 1-1, Nishinomiya, Hyogo, Japan
TEL
0798456111
Homepage URL
takuyaiseki@gmail.com
Sponsor or person
Institute
Hyogo College of Medicine
Institute
Department
Personal name
Funding Source
Organization
Hyogo College of Medicine
Organization
Division
Category of Funding Organization
Self funding
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
| 2018 | Year | 11 | Month | 10 | 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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 26 | Day |
Anticipated trial start date
| 2019 | Year | 02 | Month | 26 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 11 | Month | 09 | Day |
Last modified on
| 2019 | Year | 05 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000039734
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| Registered date | File name |
| Research case data | |
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