None listed
Conditions
Brief 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.
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.
Sponsors
North Sydney Orthopaedic Research Group
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• 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 criteria
• 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
Outcome results
None listed