Topical and intravenous tranexamic acid reduce blood loss compared to routine hemostasis in total knee arthroplasty: a multicenter, randomized, controlled trial
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Tranexamic acid (TXA) is becoming widely used in orthopedic surgery to reduce blood loss and transfusion requirements, but consensus is lacking regarding the optimal route and dose of administration. The aim of this study was to compare the efficacy and safety of topical and intravenous routes of TXA with routine hemostasis in patients undergoing primary total knee arthroplasty (TKA).
Materials and methods
We performed a randomized, multicenter, parallel, open-label clinical trial in adult patients undergoing primary TKA. Patients were divided into three groups of 50 patients each: Group 1 received 1 g topical TXA, Group 2 received 2 g intravenous TXA, and Group 3 (control group) had routine hemostasis. The primary outcome was total blood loss. Secondary outcomes were hidden blood loss, blood collected in drains, transfusion rate, number of blood units transfused, adverse events, and mortality.
One hundred and fifty patients were included. Total blood loss was 1021.57 (481.09) mL in Group 1, 817.54 (324.82) mL in Group 2 and 1415.72 (595.11) mL in Group 3 (control group). Differences in total blood loss between the TXA groups and the control group were clinically and statistically significant (p < 0.001). In an exploratory analysis differences between the two TXA groups were not statistically significant (p = 0.073) Seventeen patients were transfused. Transfusion requirements were significantly higher in Group 3 (p = 0.005). No significant differences were found between groups regarding adverse events.
We found that 1 g of topical TXA and 2 g of intravenous TXA were both safe strategies and more effective than routine hemostasis to reduce blood loss and transfusion requirements after primary TKA.
Level of evidence
KeywordsTopical and intravenous tranexamic acid Total knee arthroplasty Blood loss Transfusion
The authors wish to thank Esther Cánovas Martínez and Mercedes Subiela for data collection, Gemma Horta for logistic support, Sebastíà Videla for assistance with methodology and the revision of the manuscript, the staff at the Orthopedic Surgery Department, the secretary staff of the Iberoamerican Cochrane Centre-Clinical Epidemiology and Public Health Department, and Carolyn Newey for editing the text. The authors would also like to convey thanks to Rottapharm/Madaus for providing the tranexamic acid ampoules. Dr. Xavier Aguilera is a PhD candidate in the Surgery Department, Universitat Autónoma de Barcelona. Spain. This project was funded principally by a grant from the Spanish Ministry of Health and Social Policy to promote independent clinical research 2010 (EC10-73).
Conflict of interest
The authors declare that they have no conflict of interest.
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