Tranexamic Acid for Osteoarthritis
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using anticoagulants (except for 81mg aspirin) or combination hormonal contraception.
Is tranexamic acid generally safe for humans?
How does the drug Tranexamic Acid differ from other treatments for osteoarthritis?
Tranexamic Acid is unique for osteoarthritis as it is primarily known for its role in reducing bleeding by helping blood to clot, unlike other treatments that focus on pain relief or inflammation control. This novel approach could offer a different mechanism of action compared to traditional therapies like NSAIDs or hyaluronic acid injections.678910
What is the purpose of this trial?
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.
Research Team
Christopher Holland, MD, MS
Principal Investigator
Campbell Clinic
Eligibility Criteria
This trial is for patients with osteoarthritis who have undergone total knee arthroplasty. It's designed to see if taking oral Tranexamic acid (TXA) after surgery can help reduce blood loss and improve recovery. Patients must meet certain health criteria to join, but specific inclusion and exclusion details are not provided here.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive oral TXA or placebo for 10 days postoperatively
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Tranexamic acid
Tranexamic acid is already approved in United States, European Union, Japan for the following indications:
- Heavy Menstrual Bleeding
- Menstrual Disorders
- Bleeding Disorder
- Factor IX Deficiency
- Hemophilia A
- Melasma
- Heavy Menstrual Bleeding
- Menstrual Disorders
- Bleeding Disorder
- Factor IX Deficiency
- Hemophilia A
- Melasma
- Postpartum hemorrhage
- Heavy Menstrual Bleeding
- Menstrual Disorders
- Bleeding Disorder
- Factor IX Deficiency
- Hemophilia A
- Melasma
- Postpartum hemorrhage
Find a Clinic Near You
Who Is Running the Clinical Trial?
Campbell Clinic
Lead Sponsor