Tranexamic Acid Use on Pain, Mobility and Bleeding Following Total Hip and Total Knee Arthroplasty

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSt. Mary's Research Center, Canada

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Tranexamic acid

    Drug

    This 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

210 Participants
are divided into 3 treatment groups
Group A: 1)Standard care: 1G TXA IVActive comparator 1 intervention
Group B: 2) Standard + 1G oral TXA - 0 and 8 hours post-operativelyActive comparator 1 intervention
Group C: 3) Standard + 1G oral TXA given at 0, 8, 16 and 24 hours post-operativelyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Post-operative

Secondary outcomes

1

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)

Time frame
4 - 6 weeks post op
2

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).

Time frame
4 - 6 weeks post op
3

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.

Time frame
4 to 6 weeks postoperatively, 3 months postoperatively and 6 months post-operatively
4

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.

Time frame
4 to 6 weeks postoperatively, 3 months postoperatively and 6 months post-operatively

Other outcomes

Sponsors and contacts

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