Extended Oral Tranexamic Acid After Total Knee Arthroplasty

NCT06618820 | Enrolling By Invitation Phase 3 FDA Drug

• 1 other identifier: 24-10171-FB
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteo Arthritis Knee; Pain, Postoperative

Outcome Measures

Primary Outcomes (2)

• Forgotten Joint Score - Knee

  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.

  Enrollment; 2-week postoperative; 6-week postoperative; 12-week postoperative; 1-year postoperative.

• Range of Motion

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

  Enrollment; 2-week postoperative; 6-week postoperative; 12-week postoperative; 1-year postoperative.

Secondary Outcomes (6)

• Knee Injury and Osteoarthritis Outcome Score for Joint Replacement

  Enrollment; 2-week postoperative; 6-week postoperative; 12-week postoperative; 1-year postoperative.

• Patient-Reported Outcomes Measurement Information System

  Enrollment; 2-week postoperative; 6-week postoperative; 12-week postoperative; 1-year postoperative.

• Visual Analog Scale

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

• Opiate pill count

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

• Ambulatory aid

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

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Patients will receive 10 doses of microcrystalline cellulose (3 capsules per dose) from postoperative day (POD) 1 to POD 10.

Drug: Placebo

3-day tranexamic acid (TXA)

EXPERIMENTAL

Patients will receive three 1950 milligram (mg) doses of Oral TXA (three 650mg capsules per dose) from POD 1 to POD 3 and 7 doses of Placebo from POD 4 to POD 10.

Drug: Tranexamic acid; Drug: Placebo

10-day TXA

EXPERIMENTAL

Patients will receive ten 1950mg doses of Oral TXA (three 650mg capsules per dose) from POD 1 to POD 10.

Drug: Tranexamic acid

Interventions

Tranexamic acid DRUG

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

10-day TXA; 3-day tranexamic acid (TXA)

Placebo DRUG

One dose consists of three microcrystalline cellulose capsules.

Also known as: microcrystalline cellulose

3-day tranexamic acid (TXA); Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Campbell Clinic: lead

Study Sites (1)

Campbell Clinic

Germantown, Tennessee, 38138, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Tranexamic Acid; microcrystalline cellulose

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Christopher Holland, MD, MS

  Campbell Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants will be blinded to randomization assignment until completion of their one year follow up visits. The care provider, investigators and outcome assessor will be blinded to randomization assignment until completion of data analysis. The investigators and care providers will not be blinded to randomization assignment if an adverse event occurs.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor, Department of Orthopaedic Surgery and Biomechanical Engineering

Study Record Dates

• First Submitted: September 24, 2024
• First Posted: October 1, 2024
• Study Start: September 17, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: October 1, 2024

Record last verified: 2024-09

Locations

US (1)