Extended Oral Tranexamic Acid After Primary Total Knee Arthroplasty

NYU Langone Health

Status: Begins enrollment this month

Conditions: Knee Arthropathy

Treatments: Drug: Tranexamic acid (TXA); Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT07494032

26-00007

Details and patient eligibility

About

This study is a prospective double-blind randomized controlled trial to evaluate the effect of extended oral TXA after primary total TKA on short-term and mid-term postoperative outcomes, including function, pain, and postoperative complications over a 24-month period, with evaluations at 6 weeks, 3 months, 12 months, and 24 months. Each group of 175 patients will receive either extended oral TXA 1.95g daily or placebo for 7 days postoperatively. Function will be assessed by Knee Injury and Osteoarthritis Outcome Score, Joint Replacement (KOOS, JR) scores measured at all post operative time points as well as range of motion (ROM) (measured at all visits).

Enrollment: 350 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients are candidates for elective primary total knee arthroplasty.
• Patients ≥18 years of age
• Patients have been medically evaluated and scheduled for primary total knee arthroplasty.
• Patients undergo primary total knee arthroplasty with spinal anesthesia
• Patients receive 1g IV TXA prior to incision and 1g IV TXA at closure
• Patients are prescribed aspirin 81mg twice a day for postoperative VTE prophylaxis

Exclusion criteria

• Patients with an allergy to TXA
• Patients taking a preoperative anticoagulant other than aspirin
• Patients with a history of VTE
• Patients with chronic kidney disease
• Patients with active malignancy
• Current use of combined hormonal contraception (pill, patch, or ring)
• eGFR <60 mL/min/1.73 m² or other clinically significant renal impairment
• Use of Factor IX complex concentrates, anti-inhibitor coagulant concentrates, or all-trans retinoic acid (tretinoin)
• Anticipated need for tissue plasminogen activator (tPA) during the 7-day dosing period
• Individuals who are pregnant or breastfeeding, have a positive pre operative pregnancy test, or plan pregnancy during the 7 day dosing window. Women of childbearing potential must have a negative pre operative pregnancy test and use effective contraception through postoperative day . Individuals who are on hormonal contraceptives or hormone replacement therapies, with the exception of Progestin, are to be excluded.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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350 participants in 2 patient groups, including a placebo group

Tranexamic Acid

Experimental group

Description:

Patients treated with tranexamic acid 1.95g per day for 7 days postoperative.

Treatment:

Drug: Tranexamic acid (TXA)

Placebo

Placebo Comparator group

Description:

Patients treated with placebo daily for 7 days postoperative.

Treatment:

Drug: Placebo