UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023040 |
|---|---|
| Receipt number | R000026555 |
| Scientific Title | The efficacy of intravenous administration of tranexamic acid in curved periacetabular osteotomy |
| Date of disclosure of the study information | 2016/07/10 |
| Last modified on | 2016/07/06 14:31:28 |
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Basic information
Public title
The efficacy of intravenous administration of tranexamic acid in curved periacetabular osteotomy
Acronym
The efficacy of intravenous administration of tranexamic acid in curved periacetabular osteotomy
Scientific Title
The efficacy of intravenous administration of tranexamic acid in curved periacetabular osteotomy
Scientific Title:Acronym
The efficacy of intravenous administration of tranexamic acid in curved periacetabular osteotomy
Region
| Japan |
Condition
Condition
acetabular dysplasia
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the evidence for the efficacy of tranexamic acid in reducing blood loss after curve periacetabular osteotomy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Total Blood loss
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Intravenous tranexamic acid 1000mg at the time of incision
Interventions/Control_2
Intravenous tranexamic acid 1000mg at the time of incision and 1000mg at the time of closure
Interventions/Control_3
control subjects
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
acetabular dysplasia over twenty years of age
Key exclusion criteria
A history of VTE , renal dysfunction, use of hormone replacement therapy
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ayumi Matsunaga |
Organization
Fukuoka University
Division name
Dept.of Orthop.Surg
Zip code
Address
7-45-1 Nanakuma, Jonan-ku,Fukuoka, Japan
TEL
092-801-1011
matsunaga_s580930@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ayumi Matsunaga |
Organization
Fukuoka University
Division name
Dept.of Orthop.Surg
Zip code
Address
7-45-1 Nanakuma, Jonan-ku,Fukuoka, Japan
TEL
092-801-1011
Homepage URL
matsunaga_s580930@yahoo.co.jp
Sponsor or person
Institute
Fukuoka University,Dept.of Orthop.Surg
Institute
Department
Personal name
Funding Source
Organization
None
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
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
| 2016 | Year | 07 | 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
Preinitiation
Date of protocol fixation
| 2016 | Year | 07 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 07 | Month | 17 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 07 | Month | 06 | Day |
Last modified on
| 2016 | Year | 07 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026555
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
