CompletedPhase 4ACTRN12621001327875

Investigating the effect of tranexamic acid on recovery time in patients undergoing total knee replacements

A prospective, randomised non-blinded pilot study to investigate the effect of oral tranexamic acid on the recovery time in patients undergoing primary total knee arthroplasty.


Sponsor

Wesley Medical Research

Enrollment

80 participants

Start Date

Jan 31, 2022

Study Type

Interventional

Conditions

Summary

The purpose of the study is to evaluate a product called Tranexamic Acid (TXA) and its best use in patients who are undergoing total knee replacement. The product is currently used to reduce bleeding during and after surgical procedures. This can lessen the chance of a blood transfusion and may decrease pain, swelling and recovery time following the operation. Tranexamic Acid is already routinely used by surgeons for patients having joint replacements but there is currently no accurate information about how to dose individual patients with this medication to achieve the best results. This study will assess whether different treatment durations and doses will lead to better patient outcomes. The form of TXA that we are using in this study is one single dose in the vein-intravenously and/or an oral tablet. There are 2 treatment groups: Group 1 –Receives 1 gram of TXA intravenously 1 hour prior to surgery Group 2 – Receives 1 gram of TXA intravenously TXA 1 hour before surgery and post-operatively oral dose of 2 grams 8th hourly for a total of 6 doses.


Eligibility

Sex: Both males and femalesMin Age: 50 Yearss

Inclusion Criteria4

  • Participants of either sex scheduled to undergo a primary, unilateral Total Knee Arthroplasty.
  • Available for follow up at 6 months post-surgery.
  • Willingness to provide written, informed consent.
  • Willingness to comply with the study.

Exclusion Criteria7

  • Known allergy to TXA
  • , Acquired disturbances to colour vision
  • , Preoperative use of anticoagulants (within 5 days of surgery)
  • Fibrinolytic disorders requiring intraoperative fibrinolytics
  • Coagulopathy, history of arteriolar or venous thromboembolic disease
  • Pregnancy or breastfeeding
  • Haemoglobin <10g/dL

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Interventions

This is a randomised non-blinded pilot study for the use of Tranexamic Acid in patients that are undergoing Total Knee Arthroscopy, performed as per hospital policy. A total of 40 participants per tre

This is a randomised non-blinded pilot study for the use of Tranexamic Acid in patients that are undergoing Total Knee Arthroscopy, performed as per hospital policy. A total of 40 participants per treatment arm will be examined, 80 in total. This allows for an estimated drop-out rate of 15%. Participants will be screened and eligibility assessed from surgeons preoperative list. Once consent is completed a baseline visit will be completed including blood tests (including baseline Heamoglobin -Hb) as standard of care. Day 0- Preoperatively the following assessments will be completed: Oxford Knee Score, knee girth, range of motion, pain assessment by the anesthetist. These assessments will be repeated throughout the post operative phase whist the participant is in hospital on Day 1,2,3,4 by the physiotherapist and ward Registered nurse. All participants will receive intravenous Tranexamic acid which is standard practice Day 0- pre operatively before undergoing TKA. The alternative treatments will be randomly allocated with a 1:1 allocation to groups. Participants will be randomised at study entry. An independent statistician will conduct randomisation. Arm 1: Tranexamic Acid 1.0 gram Intravenously, on induction of anaesthesia by the anesthetist. Arm 2: Tranexamic Acid 1.0 gram Intravenously, on induction of anaesthesia by the anaesthetist. A further 6 doses of oral Tranexamic Acid 2.0 grams every 8 hours post-operatively will be administered by registered nurses on the ward. Preoperative, intraoperative and post operative procedural information, will be reviewed and the dosage of TXA and will be recorded by study staff in the source documentation. This is to verify the pre operative dosing of Intravenous TXA has been administered. This will be done on day 1,2,3,4 or day of discharge. During the post operative phase on Day 1,2,3 and 4 the inpatient medication chart will be reviewed by the anesthetist or study staff to verify that the oral doses of TXA have been administered, this will be documented in the source data. Blood Draw on day 4 or on discharge if< day 4, to assess blood loss by calculating the difference between baseline (heamoglobin (Hb) and the lowest post-operative Hb during hospital stay. As per standard of care participants will be discharged on day 4 post operatively with follow up at 6 weeks during the standard follow up surgical appointment, the Oxford Knee Score will be recorded and range of motion will be completed by the Surgeon. Final follow up at 6 months with the final Oxford Knee Score assessment by the Study Co-Ordinator. A total duration of participation in the study is 6 months.


Locations(2)

Brisbane Private Hospital - Brisbane

QLD, Australia

The Wesley Hospital - Auchenflower

QLD, Australia

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ACTRN12621001327875


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