Oral tranexamic acid to reduce blood loss in patients undergoing total knee replacements

None listed

Background and Significance Evidence supporting the use of tranexamic acid (TXA) in large joint replacements to reduce blood loss and the need for transfusion has been available for many years. To date evidence supports the use of topical or intravenous (IV) TXA, with a recent meta-analysis concluding that the two produced similar effects in the reduction of blood loss due to surgery. Very few studies have investigated the possibility of the use of oral TXA in place of topical/IV. The use of oral TXA has the potential to provide significant financial savings to healthcare facilities, with equivalent quantities of IV TXA ampoules being almost 40-fold more expensive than oral tablets. Aim and method This study aims to identify the non-inferiority of oral TXA in the reduction of peri-operative blood loss when compared to a topical/IV regimen in patients undergoing total knee replacements (TKR). In addition, the effect of pre-operative TXA on surgical blood-loss or total blood loss will be examined, in comparison to post-operative. The study will also investigate safety by incidence of deep vein thrombosis (DVT). The study will comprise of two arms, a study arm which will be treated with and oral TXA regimen and a control arm that will be treated with a currently used topical/IV TXA regimens. The TXA treatment regimens will be as follows: Study: 1g oral TXA 2hr prior to surgery, 1g oral TXA two hours post-surgery and a final 1g oral dose six hours post-surgery. Control: 3g topical TXA perioperatively, 1g IV four hours post-surgery and a final 1g oral dose eight hours post-surgery. Both groups will receive 2.5mg of oral apixaban twice daily for 15 days, commencing 8 hours post-surgery as prophylactic antithrombotic therapy. All procedures will be conducted by the same orthopaedic surgeon and the anaesthetist for the study arm will remain constant throughout. The primary outcome will be blood loss due to surgery. This data will be determined by the amount of blood loss in theatre and the volume collected from the joint drain at ten hours post-surgery. Safety will be measured by the incidence of adverse events attributed to TXA, in particular the incidence of DVT. This will be determined by means of Doppler ultrasound at six weeks post-surgery. Duration and participants The study will be ongoing with an aim of gathering approximately 50 participants in total, i.e. 25 participants per arm. All data will be collected from patients undergoing TKRs at John Flynn Private Hospital, all of which will be conducted by the same orthopaedic surgeon. Patients will be excluded if they require adjustments in the TXA regimen or changes to prophylactic antithrombotic therapy. Patient’s will also be excluded if they are undergoing a TKR revision.

No related papers found yet.