Finding the Optimal Regimen for Oral Tranexamic Acid Administration in Primary Total Hip Arthroplasty: A Randomized Controlled Trial

J Bone Joint Surg Am. 2019 Mar 6;101(5):438-445. doi: 10.2106/JBJS.18.00128.

Abstract

Background: Previous studies have confirmed that, compared with intravenous and intra-articular formulations, oral tranexamic acid (TXA) provides equivalent reduction in blood loss, at a substantially reduced cost and greater ease of administration. However, the optimal oral dosage regimen to achieve maximum blood-loss reduction remains unclear. The aim of this study was to assess the efficacy of a regimen of multiple doses of oral TXA on blood loss in primary total hip arthroplasty.

Methods: In this randomized controlled trial, 200 patients were randomized to 1 of 4 interventions. Group A received a single dose of 2.0 g of TXA orally at 2 hours preoperatively. In addition to this same preoperative dose, Group B received 1.0 g of TXA orally at 3 hours postoperatively, Group C received 1.0 g of TXA orally at 3 and 9 hours postoperatively, and Group D received 1.0 g of TXA orally at 3, 9, and 15 hours postoperatively. All patients received a 1.0-g topical dose of TXA. The primary outcome was total blood loss. Secondary outcomes included hemoglobin reduction, transfusion rate, thromboembolic complications, and adverse events.

Results: The mean total blood loss (and standard deviation) was significantly less in Groups B, C, and D (792.2 ± 293.0, 630.8 ± 229.9, and 553.0 ± 186.1 mL, respectively) than in Group A (983.6 ± 286.7 mL) (p < 0.001). Moreover, Groups C and D had a lower mean reduction in hemoglobin than did Groups A and B. However, no differences were identified between Groups C and D for blood loss and hemoglobin reduction. Additionally, no differences were observed among the groups regarding thromboembolic complications and transfusions.

Conclusions: The multiple postoperative doses of oral TXA further reduced blood loss compared with a single preoperative bolus. The regimen of a preoperative dose and 3 postoperative doses of oral TXA produced maximum effective reduction of blood loss in total hip arthroplasty.

Level of evidence: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Administration, Oral
  • Aged
  • Analysis of Variance
  • Antifibrinolytic Agents / administration & dosage*
  • Arthroplasty, Replacement, Hip / methods*
  • Double-Blind Method
  • Female
  • Hemoglobins / metabolism
  • Humans
  • Male
  • Middle Aged
  • Postoperative Complications / etiology
  • Postoperative Hemorrhage / prevention & control
  • Tranexamic Acid / administration & dosage*
  • Treatment Outcome

Substances

  • Antifibrinolytic Agents
  • Hemoglobins
  • Tranexamic Acid