Extended Oral Tranexamic Acid After Total Knee Arthroplasty

Part of paid clinical trials in Germantown, Tennessee.

Sponsor
Campbell Clinic
Study ID
NCT06618820
Phase
PHASE3
Status
Enrolling By Invitation

Conditions

  • Osteo Arthritis Knee
  • Pain, Postoperative

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Sep 17, 2024
Status verified
Sep 2024
Primary completion
Dec 31, 2025
Completion
Sep 30, 2026

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo
    Patients will receive 10 doses of microcrystalline cellulose (3 capsules per dose) from postoperative day (POD) 1 to POD 10.
  • Experimental: 3-day tranexamic acid (TXA)
    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.
  • Experimental: 10-day TXA
    Patients will receive ten 1950mg doses of Oral TXA (three 650mg capsules per dose) from POD 1 to POD 10.

Primary Outcome Measure

Forgotten Joint Score - Knee [ Time Frame: Enrollment; 2-week postoperative; 6-week postoperative; 12-week postoperative; 1-year postoperative. ]

Locations (1)

FacilityCityStateZIPSite coordinators
Campbell ClinicGermantownTennessee38138-

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Campbell Clinic· Germantown, TN

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