Clinical trial NCT06618820: Extended Oral Tranexamic Acid After Total Knee Arthroplasty
Official title: Randomized Control Trial for Oral Extended Tranexamic Acid After Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE3
Conditions: Osteo Arthritis Knee
Pain, Postoperative
Lead sponsor: Campbell Clinic
Sponsor class: OTHER
First posted: 2024-10-01
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. 18 years of age and older.
2. Primary TKA at a Campbell Clinic Surgery Center, with implant at the discretion of the treating surgeon.
3. Willing to participate in the study.
4. Fluent in oral and written English.

Exclusion Criteria:

1. Revision TKA.
2. Preoperative use of anticoagulants (81mg aspirin is allowed).
3. Prior history of deep vein thrombosis.
4. 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).
5. Known allergy or hypersensitivity to TXA.
6. Patients who are using combination hormonal contraception.
7. History of seizure disorder.
8. History of adult onset colorblindness.

Primary outcomes:
measure: Forgotten Joint Score - Knee
timeFrame: Enrollment; 2-week postoperative; 6-week postoperative; 12-week postoperative; 1-year postoperative.
measure: Range of Motion
timeFrame: Enrollment; 2-week postoperative; 6-week postoperative; 12-week postoperative; 1-year postoperative.
Secondary outcomes:
measure: Knee Injury and Osteoarthritis Outcome Score for Joint Replacement
timeFrame: Enrollment; 2-week postoperative; 6-week postoperative; 12-week postoperative; 1-year postoperative.
measure: Patient-Reported Outcomes Measurement Information System
timeFrame: Enrollment; 2-week postoperative; 6-week postoperative; 12-week postoperative; 1-year postoperative.
measure: Visual Analog Scale
timeFrame: Enrollment; postoperative day 1 to postoperative day 14; 2-week postoperative; 6-week postoperative; 12-week postoperative; 1-year postoperative.
measure: Opiate pill count
timeFrame: postoperative day 1 to postoperative day 14; 2-week postoperative; 6-week postoperative; 12-week postoperative; 1-year postoperative.
measure: Ambulatory aid
timeFrame: Enrollment; postoperative day 1 to postoperative day 14; 2-week postoperative; 6-week postoperative; 12-week postoperative; 1-year postoperative.
measure: Adverse Event
timeFrame: From signing consent form to completion of 1 year follow up visit.
Other outcomes:
Locations:
city: Germantown
country: United States
facility: Campbell Clinic
state: Tennessee
Study officials:
affiliation: Campbell Clinic
name: Christopher Holland, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: