Extended Oral Tranexamic Acid After Total Knee Arthroplasty

Enrolling by invitation · Phase 3 · Has a placebo group

Conditions studied: Osteo Arthritis Knee, Pain, Postoperative

In brief

The utilization of intraoperative tranexamic acid (TXA), whether administered intravenously or orally, has become a standard practice in total joint arthroplasty (TJA). Multiple studies have demonstrated the positive impact that TXA application has on clinical outcomes, including decreased blood loss and transfusion rates, decreased early swelling and ecchymosis, improved early recovery, and potentially superior long-term outcomes. Its ability to mitigate risk of blood loss made ambulatory total knee arthroplasty (TKA) safer for patients. The safety of intraoperative TXA use has also been documented. Sabbag et al. showed that TXA does not increase the risk of venous thromboembolism (VTE), even in those patients who are deemed high-risk. Multiple routes of TXA administration have been studied with each route demonstrating effectiveness in reducing blood loss. Findings showed that oral TXA is noninferior to intravenous TXA, though the median time to reach a target concentration is longer via the oral route and bioavailability is lower. With the benefits of intraoperative TXA clearly documented in literature, multiple centers investigated the utilization of extended TXA postoperatively in hopes of enhancing patient safety and reducing length of stay and healthcare cost. However, these studies reported conflicting outcomes and mostly focused on estimated blood loss, instead of patient reported outcomes. The purpose of this study is to assess the effectiveness and safety of a varying extended oral TXA regimen during the postoperative period. Further, the investigators aim to determine the optimal duration of the TXA regimen to maximize its impact. The investigators hypothesize that an extended oral TXA regimen is safe and effective in improving clinical outcomes in TKA patients.

Key facts

Study ID

NCT06618820

Run by

Campbell Clinic

People needed

120

Starts

2024-09-17

Expected to finish

2026-09-01

Last updated by the study team

2024-10-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18 years of age and older.
• Primary TKA at a Campbell Clinic Surgery Center, with implant at the discretion of the treating surgeon.
• Willing to participate in the study.
• Fluent in oral and written English.

You may not qualify if…

• Revision TKA.
• Preoperative use of anticoagulants (81mg aspirin is allowed).
• Prior history of deep vein thrombosis.
• Prior history of cancer (with the exception of non-melanoma/metastatic skin cancers, low-grade non-metastatic benign soft tissue tumors, thyroid cancers and low grade, non-metastatic prostate cancers).
• Known allergy or hypersensitivity to TXA.
• Patients who are using combination hormonal contraception.
• History of seizure disorder.
• History of adult onset colorblindness.

Where it is running

• Campbell Clinic — Germantown, Tennessee, United States

Full record on ClinicalTrials.gov

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