NCT06618820

Extended Oral Tranexamic Acid After Total Knee Arthroplasty

Randomized Control Trial for Oral Extended Tranexamic Acid After Total Knee Arthroplasty

• Status: Enrolling By Invitation
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Campbell Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Osteo Arthritis Knee
• Pain, Postoperative

Interventions

Type	Name	Description
DRUG	Tranexamic acid	One dose consists of three 650 milligram (mg) capsules, to be taken orally.
DRUG	Placebo	One dose consists of three microcrystalline cellulose capsules.

Timeline

• Start date: 2024-09-17
• Primary completion: 2025-12-01
• Completion: 2026-09-01
• First posted: 2024-10-01
• Last updated: 2024-10-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study