UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028871 |
|---|---|
| Receipt number | R000033037 |
| Scientific Title | Effect of intraarticular tranexamic acid on reducing blood loss after arthroplasty. |
| Date of disclosure of the study information | 2017/08/29 |
| Last modified on | 2019/09/03 00:23:32 |
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Basic information
Public title
Effect of intraarticular tranexamic acid on reducing blood loss after arthroplasty.
Acronym
Effect of intraarticular tranexamic acid on reducing blood loss after arthroplasty.
Scientific Title
Effect of intraarticular tranexamic acid on reducing blood loss after arthroplasty.
Scientific Title:Acronym
Effect of intraarticular tranexamic acid on reducing blood loss after arthroplasty.
Region
| Japan |
Condition
Condition
osteoarthritis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We investigate the effect of intraarticular tranexamic acid on reducing blood loss after arthroplasty.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome is total blood loss (postoperative day 1).
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
After the skin incision was closed, tranexamic acid is infiltrated into the joint.
Interventions/Control_2
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
Ptients undergoing primary arthroplasty.
Key exclusion criteria
Patients with allergy to tranexamic acid, preoperative renal dysfunction, deranged coagulation profile and history of thromboembolic disease.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Hasegawa |
Organization
Mie University Graduate School of Medicine
Division name
Orthopaedic Surgery
Zip code
514-8507
Address
2-174 Edobashi Tsu Mie
TEL
0592321111
seikei@clin.medic.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | Yohei |
| Middle name | |
| Last name | Naito |
Organization
Mie University Graduate School of Medicine
Division name
Orthopaedic Surgery
Zip code
514-8507
Address
2-174 Edobashi Tsu Mie
TEL
0592321111
Homepage URL
seikei@clin.medic.mie-u.ac.jp
Sponsor or person
Institute
Mie University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Self funding.
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
Mie University Hospital
Address
2-174 Edobashi Tsu Mie
Tel
0592321111
kk-sien@mo.medic.mie-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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 08 | Month | 29 | 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
| 2016 | Year | 12 | Month | 14 | Day |
Date of IRB
| 2016 | Year | 11 | Month | 24 | Day |
Anticipated trial start date
| 2016 | Year | 12 | Month | 15 | Day |
Last follow-up date
| 2020 | Year | 12 | 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
| 2017 | Year | 08 | Month | 28 | Day |
Last modified on
| 2019 | Year | 09 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033037
