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Not yet recruiting NCT07685743

Extended Post-operative Oral TXA in Primary THA

Phase IV Interventional Osteoarthritis (OA) of the Hip Osteoarthritis (OA) of the Knee

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Extended oral tranexamic acid regimen, Placebo.
Who it may be relevant to
Registry conditions: Osteoarthritis (OA) of the Hip, Osteoarthritis (OA) of the Knee. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Extended Post-operative Oral TXA vs.Standard Perioperative TXA in Primary TJA: A Randomized, Double-Blind, Placebo-Controlled Trial

Overview

The goal of this clinical trial is to learn if extended post-operative oral tranexamic acid (TXA) - a medication that reduces bleeding by slowing the breakdown of blood clots - can improve functional recovery following surgery in adults undergoing primary total knee or hip arthroplasty for osteoarthritis. The main question it aims to answer is: Does extended post-operative oral TXA improve functional outcomes at 6 weeks post-operatively compared to standard perioperative TXA alone? Researchers will compare patients receiving extended oral TXA to patients receiving matching placebo capsules on the same schedule to see if the extended TXA regimen reduces blood loss, improves early functional outcomes, and reduces pain without increasing complication rates. Participants will receive standard perioperative oral TXA (1.95 g) prior to surgical incision, along with standard VTE prophylaxis. They will be randomly assigned to receive either oral TXA or matching placebo capsules once daily on post-operative days 1, 2, and 3. Participants will attend follow-up visits at 2, 6, and 12 weeks post-operatively to complete functional outcome questionnaires, pain assessments, and - for knee replacement patients - range of motion measurements.

Interventions

  • Drug Extended oral tranexamic acid regimen
    Participants in the intervention group will receive 1.95mg of oral tranexamic acid on post-operative day 1, 2, and 3.
  • Drug Placebo
    Patients will receive an oral placebo medication on post-operative day 1, 2, and 3.

Primary outcome measures

  • 6-week Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR) or Hip injury and Osteoarthritis Outcome Score for Joint Replacement (HOOS JR) score [Time frame: At 6 weeks from timing of surgical intervention]
Secondary outcome measures (12)
  • 2-week Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR) or Hip injury and Osteoarthritis Outcome Score for Joint Replacement (HOOS JR) score [Time frame: At 2 weeks from timing of surgical intervention]
  • 12-week Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR) or Hip injury and Osteoarthritis Outcome Score for Joint Replacement (HOOS JR) score [Time frame: At 12 weeks from timing of surgical intervention]
  • 2-week Visual Analog Scale (VAS) pain score [Time frame: At 2 weeks from timing of surgical intervention]
  • 6-week Visual Analog Scale (VAS) pain score [Time frame: At 6 weeks from timing of surgical intervention]
  • 12-week Visual Analog Scale (VAS) pain score [Time frame: At 12 weeks from timing of surgical intervention]
  • 6-week absolute knee flexion [Time frame: At 6 weeks from timing of surgical intervention]
  • Transfusion rate [Time frame: From enrollment to end of treatment at 12 weeks from timing of surgical intervention]
  • Blood product units transfused [Time frame: From enrollment to end of treatment at 12 weeks from timing of surgical intervention]
  • Incidence of Symptomatic DVT [Time frame: From enrollment to end of treatment at 90 days from timing of surgical intervention]
  • Incidence of Symptomatic PE [Time frame: From enrollment to end of treatment at 90 days from timing of surgical intervention]
  • Incidence of Acute Coronary Sndrome [Time frame: From enrollment to end of treatment at 90 days from timing of surgical intervention]
  • Incidence of Cerebrovascular Accident [Time frame: From enrollment to end of treatment at 90 days from timing of surgical intervention]

Eligibility criteria

Inclusion criteria

  • Age ≥18 years
  • Undergoing primary total knee arthroplasty (TKA) or total hip arthroplasty (THA) for osteoarthritis
  • Ability to provide written informed consent
  • Willingness to comply with study protocol

Exclusion criteria

  • History of venous thromboembolism (DVT or PE)
  • Active malignancy
  • Allergy or contraindication to tranexamic acid (TXA)
  • Post-operative anticoagulation therapy other than aspirin
  • History of color blindness or retinal disease

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07685743 · 30119

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗