Comparison of oral vs. combined topical/intravenous/oral tranexamic acid in the prevention of blood loss in total knee arthroplasty: A randomised clinical trial

Liam King; Raymond Randle; Wendy Dare; Nijole Bernaitis

doi:10.1016/j.otsr.2019.06.008

Comparison of oral vs. combined topical/intravenous/oral tranexamic acid in the prevention of blood loss in total knee arthroplasty: A randomised clinical trial

Orthop Traumatol Surg Res. 2019 Oct;105(6):1073-1077. doi: 10.1016/j.otsr.2019.06.008. Epub 2019 Aug 28.

Authors

Liam King¹, Raymond Randle², Wendy Dare³, Nijole Bernaitis⁴

Affiliations

¹ Ramsay Pharmacy Services, John Flynn Hospital, Queensland, Australia; School of Pharmacy and Pharmacology, Griffith University, Queensland, Australia; Quality Use of Medicines Network, Griffith University, Queensland, Australia.
² The Gold Coast Centre for Bone & Joint Surgery, John Flynn Hospital, Queensland, Australia.
³ Ramsay Pharmacy Services, John Flynn Hospital, Queensland, Australia; Quality Use of Medicines Network, Griffith University, Queensland, Australia.
⁴ School of Pharmacy and Pharmacology, Griffith University, Queensland, Australia; Quality Use of Medicines Network, Griffith University, Queensland, Australia. Electronic address: n.bernaitis@griffith.edu.au.

PMID: 31473130
DOI: 10.1016/j.otsr.2019.06.008

Abstract

Background: Tranexamic acid (TXA) has long been used to reduce blood loss associated with total knee arthroplasty (TKA). Debate remains over the best administration route with limited data comparing regimes including, to date, no studies investigating the equivalence of oral TXA and a combined topical/intravenous (IV) regime. Therefore, the aim of this study was to compare the efficacy and safety of oral TXA to combined topical/IV/oral TXA.

Working hypothesis: We postulated that oral TXA would offer the same efficacy and safety as combined topical/IV/oral regime. We asked: (1) Would blood loss and haemoglobin change be affected? (2) Would complication rates increase?

Patients and methods: Patients were randomised into either the study group (oral TXA regimen) or the control group (combined topical/IV/oral TXA). Both groups were administered three doses of TXA and received the same post-operative venous thromboembolism prophylaxis. Efficacy outcomes including blood loss and haemoglobin (Hb) change were investigated, together with safety outcomes of incidence of deep vein thrombosis and adverse events.

Results: The study (n=25) and control (n=28) group were comparable at baseline (eg pre-op haemoglobin). No significant difference was found between the study and control group in terms of Hb change (32.9±8.9 vs. 31.8±10.4, p=0.687) or blood loss (measured 640.0±291.1 vs. 538.3±270.2, p=0.173 and total 1211.5±336.0 vs. 1092.9±341.4, p=0.214). No cases of DVT were reported for either group and no statistical differences were found in the incidence of adverse events (nausea, hypotension, constipation) between groups.

Discussion: This study has shown for the first time that an oral TXA regimen is non-inferior to a topical/IV/oral regimen in TKA in efficacy and safety. Utilising oral TXA in place of a combined topical/IV/oral regime can significantly reduce costs without compromising patient outcomes.

Level of evidence: II, Randomised controlled trial.

Keywords: Total knee arthroplasty; Tranexamic acid.

Publication types

Comparative Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

MeSH terms

Administration, Intravenous
Administration, Oral
Administration, Topical
Aged
Antifibrinolytic Agents / administration & dosage*
Arthroplasty, Replacement, Knee / methods*
Blood Loss, Surgical / prevention & control*
Blood Transfusion
Clinical Protocols
Female
Hemoglobins / metabolism
Humans
Male
Middle Aged
Postoperative Complications / epidemiology
Tranexamic Acid / administration & dosage*
Venous Thromboembolism / epidemiology
Venous Thrombosis / epidemiology

Substances

Antifibrinolytic Agents
Hemoglobins
Tranexamic Acid