Background: Questions remain, mainly concerning whether tranexamic acid (TXA) is truly safe since all available trials were underpowered to identify clinically important differences. The objective of this study is to evaluate the safety of TXA by using a novel technique-thromboelastography (TEG).
Methods: A retrospective review was conducted on 359 consecutive patients who underwent primary total hip arthroplasty (THA) or total knee arthroplasty (TKA) and received multiple-dose or single-dose of TXA at a tertiary academic center. TEG parameters, TEG coagulation status, conventional coagulation test parameters, and incidence of thrombotic events were used for safety evaluation.
Results: Compared with single-dose cohort, patients who received multiple-dose of TXA had consistent statistically significant shortened R times on post-operative day 1 (POD1) and POD3 in both THA (POD1: 4.06 ± 0.71 s versus 4.45 ± 1.28 s, P = 0.011; POD3: 4.36 ± 0.83 s versus 5.12 ± 1.64 s, P < 0.0001) and TKA (POD1: 3.90 ± 0.73 s versus 4.29 ± 0.92 s, P = 0.011; POD3: 4.24 ± 0.94 s versus 4.65 ± 1.07 s, P = 0.023), while the K, α-angle, and MA values were similar during the perioperative period. TEG coagulation status analysis indicated that patients were significantly (P = 0.003) more likely with hypercoagulable status during the course of multiple-dose TXA. Conventional coagulation test parameters were similar. Only one patient developed calf vein thrombosis in the multiple-dose cohort.
Conclusions: Multiple-dose of TXA was associated with aggravated hypercoagulable state when compared with single-dose of TXA, but this prothrombotic state does not provoke thrombosis when combined with appropriate anticoagulant therapy. Therefore, multiple-dose of TXA remains safe and could be recommended for clinical practice. Potential benefits and possible risks should be trade-off when considering increasing the dosage and frequency of TXA on the present basis.
Trial registration: ChiCTR1800015422 .
Keywords: Multiple-dose; Safety; Thromboelastography; Total hip arthroplasty; Total knee arthroplasty; Tranexamic acid.