Tokyo, Oct. 9 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059346) titled 'The Impact of Postoperative Tranexamic Acid on Knee Swelling After Total Knee Arthroplasty' on Oct. 9.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - No treatment
Primary Sponsor:
Institute - Takagi Hospital Oume Knee Surgery Center
Condition:
Condition - Knee osteoarthritis
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - This study aims to evaluate whether a 14-day course of postoperative tranexamic acid (TXA) can effectively alleviate swelling.
Basic objectives2 - Efficacy
Intervention:
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.
Eligibility:
Age-lower limit - 50
years-old
=
Gender - Male and Female
Key inclusion criteria - Patients will receive tranexamic acid (TXA) at a dose of 1000 mg twice daily from postoperative day 1 to day 14. For patients with an estimated glomerular filtration rate (eGFR) between 30 and 60, the dose will be adjusted to 500 mg twice daily. Patients with eGFR > 60 will receive 1000 mg twice daily.
Key exclusion criteria - Patients with an estimated glomerular filtration rate (eGFR) below 30.
Target Size - 100
Recruitment Status:
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
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067406
Disclaimer: Curated by HT Syndication.