Not Yet RecruitingPhase 4ACTRN12625000926437

Extended Postoperative Oral Tranexamic Acid In Total Hip and Knee Arthroplasty: A Randomised Controlled Study

Extended Postoperative Oral Tranexamic Acid on Patient-Reported and Functional Outcomes In Total Hip and Knee Arthroplasty: A Randomised Controlled Study

Sponsor

North Sydney Orthopaedic Research Group

Enrollment

200 participants

Start Date

Sep 1, 2025

Study Type

Interventional

Conditions

Osteoarthritis Total Hip Arthroplasty Total Knee Arthroplasty

Summary

Tranexamic Acid (TXA) is a commonly used medication which has been shown in many studies to reduce blood loss after total joint replacement. TXA is approved for use in Australia by the Australian Federal Government. TXA administration is widely endorsed as best practice after total joint replacement by the clinical practice guidelines of the American Association of Hip and Knee Surgeons, American Society of Regional Anaesthesia and Pain Medicine, American Academy of Orthopaedic Surgeons, Hip Society, and Knee Society. We are conducting a study to validate whether extended oral TXA use post surgery can improve total hip and knee replacement outcomes to improve confidence in its routine administration (during surgery) after total joint replacement.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria3

Unilateral primary elective THA or TKA patients under the care of the investigating surgeons, with the underlying diagnosis of osteoarthritis at the Mater Hospital North Sydney
Age 18-year-old or older
Ability to give written informed consent and willingness to comply with the requirement of the study, including but not limited to the randomisation process.

Exclusion Criteria12

Participants with the history of venous thromboembolism (VTE), such as deep vein thrombosis (DVT), pulmonary embolism (PE) and cerebral thrombosis in the last 6 months
Participants who are allergic to TXA or Aspirin
Participants who are hypersensitive to TXA or any of its non-active ingredients.
Participants who are already on antiplatelets medication preoperatively other than Aspirin
Participants with subarachnoid haemorrhage
Significant medical history for liver and renal insufficiency (such as chronic kidney disease, renal failure, kidney transplant, haematuria, dialysis)
Participants with a blood clotting disorders or thrombophilias
Participants with anaemia with Hb <90 g/L preoperatively,
Participants with intraoperative complications requiring immediate intervention/s, which will intervene the standard routine post-operative care following THA or TKA (i.e perioperative fractures, vascular injuries, unplanned ICU admission)
Participants who are pregnant or breastfeeding
Participants with acquired disturbances of colour vision
Participants with a history of a psychological illness or condition such as to interfere with the ability to understand the requirements of the study, or complete the survey

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Interventions

The ‘treatment group’ will receive the TXA dose intravenously, 1 gram at the start of procedure and 1 gram before the wound closure PLUS additional once daily oral tablets of TXA 2 grams (4 x 500 mgs capsules) on the day of surgery (at least 8 hours after the last IV dose), and for 3 subsequent days. The TXA intravenous dose in operating room will be administered by the anesthetist. The oral TXA dose in acute stay will be administered by the nursing staff.