Tokyo, Sept. 4 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062081) titled 'Effect of Aspirin Co-administration Under Tranexamic Acid Therapy on Postoperative Venous Thromboembolism After Total Knee Arthroplasty: A Prospective Double-blind Randomized Controlled Trial Using Lower Limb Ultrasonography' on Sept. 4.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Double blind -all involved are blinded Control - Placebo

Primary Sponsor: Institute - Takagi Hospital

Condition: Condition - Osteoarthritis of the knee requiring primary total knee arthroplasty Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - Venous thromboembolism (VTE) remains a clinically significant complication after total knee arthroplasty (TKA), and its prevention continues to be an important challenge in perioperative management. In recent years, low-dose aspirin has been increasingly adopted in Western countries as a standard prophylactic agent for postoperative VTE due to its favorable balance of efficacy and safety. At the same time, postoperative knee swelling, subcutaneous bleeding, and pain can delay rehabilitation, highlighting the need for a prophylactic strategy that suppresses thrombosis without increasing postoperative bleeding or inflammation. Tranexamic acid (TXA) is widely used to reduce postoperative bleeding and inflammation, and previous studies have shown that TXA does not increase the risk of VTE. However, no prospective double-blind randomized controlled trials have evaluated the effectiveness and safety of combining postoperative TXA therapy with low-dose aspirin for VTE prevention after TKA.This study aims to determine whether adding low-dose aspirin (100 mg/day for 3 weeks) to a 3-week postoperative oral TXA regimen reduces the incidence of lower limb deep vein thrombosis (DVT) at 3 weeks after TKA, compared with TXA alone. In addition, the study will evaluate the effects of aspirin co-administration on postoperative knee swelling, subcutaneous ecchymosis, pain, range of motion, and other orthopedic outcomes. Through these assessments, the study seeks to clarify the overall efficacy and safety of combining TXA and aspirin in postoperative management following TKA. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Postoperative oral tranexamic acid for 3 weeks combined with low-dose aspirin 100 mg/day for 3 weeks after total knee arthroplasty. Interventions/Control_2 - Postoperative oral tranexamic acid for 3 weeks combined with a placebo tablet (lactose) for 3 weeks after total knee arthroplasty.

Eligibility: Age-lower limit - 50 years-old = Gender - Male and Female Key inclusion criteria - Willingness to participate in a 3 week postoperative medication protocol and ability to provide written informed consent. Key exclusion criteria - Patients with bilateral total knee arthroplasty (TKA). Patients with contraindications to tranexamic acid (TXA) or aspirin, including peptic ulcer disease, severe renal impairment, or bleeding tendency. Patients who are unable to provide written informed consent. Patients deemed unsuitable for study participation by the principal investigator, including those with severe renal or hepatic dysfunction. Target Size - 110

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 06 Month 27 Day Date of IRB - 2026 Year 06 Month 26 Day Anticipated trial start date - 2026 Year 09 Month 04 Day Last follow-up date - 2027 Year 10 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071034

Disclaimer: Curated by HT Syndication.