Abstract
Introduction
The use of tranexamic acid (TXA) in primary total hip arthroplasty (THA) is supported by many studies that confirm its efficacy for decreasing blood loss, but the comparison between topical intra-articular (IA) and intra-venous (IV) is unclear, especially combined with chemical prophylaxis. The purpose of this study is to verify non-inferior efficacy of topical IA TXA compared with IV TXA in primary THA.
Methods & Methods
A single center, randomized, controlled clinical trial was performed to compare topical IA TXA (2 g of TXA in 100 cc of normal saline) with two IV doses of TXA (1 g dose before surgery and another 1 g dose 3 hours later) on blood loss. The primary outcome was total blood loss as calculated from the difference between the preoperative hemoglobin (Hb) and the lowest postoperative Hb. The secondary outcome included drained blood loss, transfusion volume, and thromboembolic events. The sample size of 112 patients was calculated to give a statistical power of 99% for demonstrating inferiority. Fifty-six patients each was assigned to receive topical IA TXA (IA group) and IV TXA (IV group). There were no significant differences in demographics and preoperative laboratory values between the two groups. Non-inferiority was estimated by comparing the confidence interval with a delta of 10%. All subjects took oral direct factor Xa inhibitor to prevent venous thromboembolism included during 2 weeks after surgery.
Results
The total blood loss was 875.0 mL (range, 199.7 – 2149.2 mL) in topical IA group and 1070.2 mL (range, 389.5 – 2738.8 mL) and thus, non-inferiority was demonstrated for the primary efficacy end point (p<0.001). Drained blood loss also show a significant difference (370.1 ± 77.4 versus 539.9 ± 180 mL, p=0.037). The number of patients given transfusion was 9 (16.1%) and 19 (33.9%) in IV group (p=0.029) and the number of transfusion units was 0.2 (range, 0 – 2) in topical IA group and 0.5 (range 0 – 3) in IV group (p=0.027). No significant difference was seen in thromboembolic events between groups.
Conclusions
Topical IA administration of TXA demonstrated non-inferiority compared with IV TXA. Our findings support the topical IA use of TXA in primary THA.
