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Enrolling by Invitation

NCT Number: NCT06618820

Extended Oral Tranexamic Acid After Total Knee Arthroplasty

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.

Enrolling by Invitation

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Campbell Clinic

Germantown, Tennessee, 38138, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Tranexamic Acid

Drug

One dose consists of three 650 milligram (mg) capsules, to be taken orally.

Placebo

Drug

One dose consists of three microcrystalline cellulose capsules.

Other names: microcrystalline cellulose

Primary outcomes

  1. Forgotten Joint Score - Knee

    Time frame: Enrollment; 2-week postoperative; 6-week postoperative; 12-week postoperative; 1-year postoperative.

    The Forgotten Joint Score measures how much the patient is aware of their affected knee during activities of daily living. A score of 0 indicates that the patient is always aware of their affected knee whereas a score of 100 indicates that the patient is not aware of their affected knee during activities of daily living.

  2. Range of Motion

    Time frame: Enrollment; 2-week postoperative; 6-week postoperative; 12-week postoperative; 1-year postoperative.

    Passive flexion and extension range of motion of the surgical knee will be assessed with a goniometer in degrees.

Secondary outcomes

  1. Knee Injury and Osteoarthritis Outcome Score for Joint Replacement

    Time frame: Enrollment; 2-week postoperative; 6-week postoperative; 12-week postoperative; 1-year postoperative.

    This questionnaire assesses patients' knee health with 0 representing total disability and 100 represents perfect knee health.

  2. Patient-Reported Outcomes Measurement Information System

    Time frame: Enrollment; 2-week postoperative; 6-week postoperative; 12-week postoperative; 1-year postoperative.

    This questionnaire assesses patients' overall health and wellbeing with a T-score of 16.2 representing most severe physical impairment and a T-score of 67.7 represents best possible state of health.

  3. Visual Analog Scale

    Time frame: Enrollment; postoperative day 1 to postoperative day 14; 2-week postoperative; 6-week postoperative; 12-week postoperative; 1-year postoperative.

    This questionnaire assesses patient's pain level with 0 being no pain at all and 10 being worst pain possible.

  4. Opiate pill count

    Time frame: postoperative day 1 to postoperative day 14; 2-week postoperative; 6-week postoperative; 12-week postoperative; 1-year postoperative.

    The investigators will record the number of opiate medication taken by the patient and calculate morphine milligram equivalents.

  5. Ambulatory aid

    Time frame: Enrollment; postoperative day 1 to postoperative day 14; 2-week postoperative; 6-week postoperative; 12-week postoperative; 1-year postoperative.

    The investigators will record the use of ambulatory aid, such as walker.

  6. Adverse Event

    Time frame: From signing consent form to completion of 1 year follow up visit.

    The investigators will monitor for adverse events, including but not limited to deep venous thrombosis, and pulmonary embolism.

Sponsors and collaborators

Lead sponsor

Campbell Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Oct 1, 2024
Registry last updated
Oct 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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