About this trial
Tranexamic acid (TXA) is an anti-fibrinolytic agent developed in the 1960s that has been safely used to reduce blood loss, transfusion rates and bleeding-associated mortality in trauma, obstetrics and orthopedic surgery, including hip fracture care and arthroplasty.
The efficacy and safety profile of TXA has been extensively studied in numerous clinical trials and observational studies. Its wide range of applications, combined with its favourable risk-benefit ratio, has led to the incorporation of TXA into clinical guidelines and protocols worldwide.
This RCT aims to compare the current standard dosing for TXA to additional TXA doses given orally post-operatively for THA and TKA patients. The goal is to compare the following between study groups: visible bleeding on post-operative dressing, mobilization (steps, amount of time moving around), pain (visual analog scale), function (Oxford hip and knee scales) and ROM at four to six weeks.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
Age < 18 years
Known hypersensitivity or allergy to TXA
Previous history of thromboembolic disease
Active malignancy (all current cancers other than local skin cancer)
Trial design
Parallel
Treatments tested in this trial
Tranexamic acid
DrugThis is a 3 arm RCT using the three dosage regimens mentioned above. Placebo doses will be provided for the 0, 8, 16 and 24 hours without TXA
Treatment groups
Trial outcomes
Primary outcomes
Step counts at 24 and 48 hours post -operative
We hypothesize that patients receiving additional doses of TXA will mobilize more at 24 and 48 hours post- operatively and that this will be dose-dependent.
Secondary outcomes
Range of motion (ROM) of the hip (if applicable):
Measuring ROM of the hip taken pre-operatively, post-operatively and 4 to 6 weeks post-operatively if patient received a total hip arthroplasty (THA)
Range of motion (ROM) of the knee (if applicable):
Measuring ROM of the knee taken pre-operatively, post-operatively and 4 to 6 weeks post-operatively if patient received a total knee arthroplasty (TKA).
Patient self-assessment of functionality and pain measured pre-operatively, 4 to 6 weeks postoperatively, 3 months postoperatively and 6 months post-operatively following total hip arthroplasty utilizing the Oxford Hip Score (OHS):
Minimal value of 0 and maximal value of 48. The higher scores indicate more satisfactory joint function.
Patient self-assessment of functionality and pain measured pre-operatively, 4 to 6 weeks postoperatively, 3 months postoperatively and 6 months post-operatively following total knee arthroplasty utilizing the Oxford Knee Score (OKS):
joint function.
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