UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059346 |
|---|---|
| Receipt number | R000067406 |
| Scientific Title | The Impact of Postoperative Oral Tranexamic Acid on Knee Swelling After Total Knee Arthroplasty |
| Date of disclosure of the study information | 2025/10/09 |
| Last modified on | 2025/12/02 06:17:34 |
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Basic information
Public title
The Impact of Postoperative Tranexamic Acid on Knee Swelling After Total Knee Arthroplasty
Acronym
TXA in TKA: A Randomized Controlled Trial
Scientific Title
The Impact of Postoperative Oral Tranexamic Acid on Knee Swelling After Total Knee Arthroplasty
Scientific Title:Acronym
TXA in TKA: A Randomized Controlled Trial
Region
| Japan |
Condition
Condition
Knee osteoarthritis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate whether a 14-day course of postoperative tranexamic acid (TXA) can effectively alleviate swelling.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
Knee circumference measurements were performed preoperatively and on postoperative days 1, 3, 7, 14, and 21.
Key secondary outcomes
Pain Visual Analog Scale (VAS) scores on postoperative days 7, 14, and 21
Knee range of motion (ROM)
Hemoglobin reduction rate
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as a block.
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
A group of 50 patients undergoing primary unilateral total knee arthroplasty (TKA) between September 2025 and October 2026, who will receive postoperative tranexamic acid administration.
Interventions/Control_2
A control group of 50 patients undergoing primary unilateral total knee arthroplasty (TKA) between September 2025 and October 2026, who will not receive postoperative tranexamic acid 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
| 45 | years-old | <= |
Age-upper limit
| 89 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients will receive tranexamic acid for 14 days postoperatively, administered at 1000 mg twice daily. On the day of surgery and the following day, the drug will be given intravenously; thereafter, for the subsequent 12 days, it will be administered orally.
For patients with an eGFR between 30 and 60, tranexamic acid will be given at 500 mg twice daily. For patients with an eGFR > 60, the dosage will be 1000 mg twice daily.
Key exclusion criteria
Patients with an estimated glomerular filtration rate (eGFR) below 30.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yoshinori |
| Middle name | |
| Last name | Mikashima |
Organization
Takagi Hospital
Division name
Oume Knee Surgery Center
Zip code
198-0021
Address
Imadera 5-18-19, Oume City, Tokyo
TEL
08020926874
ymikashima2007@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Yoshinori |
| Middle name | |
| Last name | Mikashima |
Organization
Takagi Hospital
Division name
Oume Knee Surgery Center
Zip code
198-0021
Address
Imadera 5-18-19, Oume City, Tokyo
TEL
0428315255
Homepage URL
https://www.takagi-hp.or.jp/
ymikashima2007@yahoo.co.jp
Sponsor or person
Institute
Takagi Hospital Oume Knee Surgery Center
Institute
Department
Personal name
Yoshinori Mikashima
Funding Source
Organization
No external funding was received.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
None
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Takagi Hospital
Address
Imadera 5-18-19, Oume City, Tokyo
Tel
0428315255
ymikashima2007@yahoo.co.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
| 2025 | Year | 10 | Month | 09 | 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
| 2025 | Year | 10 | Month | 09 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 02 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 09 | Day |
Last follow-up date
| 2027 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2027 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2027 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2027 | Year | 08 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2025 | Year | 10 | Month | 09 | Day |
Last modified on
| 2025 | Year | 12 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067406
