Newly Published
Perioperative Medicine  |   July 2017
Intravenous Tranexamic Acid Bolus plus Infusion Is Not More Effective than a Single Bolus in Primary Hip Arthroplasty: A Randomized Controlled Trial
Author Notes
  • From INSERM, U1059, Hemostasis and Vascular Dysfunction, F-42023, Saint-Etienne, France (P.J.Z., J.L., C.C., X.D.); Department of Anesthesiology and Intensive Care Medicine, University Hospital of Saint-Etienne, F-42055, Saint-Etienne, France (P.J.Z., J.L., J.-Y.B., P.L., S.M.); Clinical Research Unit Innovation and Pharmacology, University Hospital of Saint-Etienne, F-42055, Saint Etienne, France (P.J.Z., C.C.); Department of Anesthesiology and Intensive Care Medicine, Northern State Medical University, Arkhangelsk, Russian Federation (D.B.B.); Orthopedic and Trauma Center, University Hospital of Saint-Etienne, F-42055, Saint-Etienne, France (R.P.); University of Lyon, Saint-Etienne, F-42023, France (R.P., X.D.); EA 7424, Inter-university Laboratory on Motor Biology, F-42023, Saint-Etienne, France (R.P.); and Laboratory of Pharmacology and Toxicology, University Hospital of Saint-Etienne, F-42055, Saint-Etienne, France (X.D.).
  • Coordinating and Methods Center, Clinical Research Unit Innovation and Pharmacology, CHU de Saint-Etienne, F-42055, Saint-Etienne, France
  • Coordinating and Methods Center, Clinical Research Unit Innovation and Pharmacology, CHU de Saint-Etienne, F-42055, Saint-Etienne, France
  • Coordinating and Methods Center, Clinical Research Unit Innovation and Pharmacology, CHU de Saint-Etienne, F-42055, Saint-Etienne, France
  • Coordinating and Methods Center, Clinical Research Unit Innovation and Pharmacology, CHU de Saint-Etienne, F-42055, Saint-Etienne, France
  • Coordinating and Methods Center, Clinical Research Unit Innovation and Pharmacology, CHU de Saint-Etienne, F-42055, Saint-Etienne, France
  • Department of Anesthesiology and Intensive Care Medicine, CHU de Saint-Etienne, F-42055, Saint-Etienne, France
  • Department of Anesthesiology and Intensive Care Medicine, CHU de Saint-Etienne, F-42055, Saint-Etienne, France
  • Department of Anesthesiology and Intensive Care Medicine, CHU de Saint-Etienne, F-42055, Saint-Etienne, France
  • Department of Anesthesiology and Intensive Care Medicine, CHU de Saint-Etienne, F-42055, Saint-Etienne, France
  • Department of Anesthesiology and Intensive Care Medicine, CHU de Saint-Etienne, F-42055, Saint-Etienne, France
  • Supplemental Digital Content is available for this article. Direct URL citations appear in the printed text and are available in both the HTML and PDF versions of this article. Links to the digital files are provided in the HTML text of this article on the Journal’s Web site (www.anesthesiology.org).
    Supplemental Digital Content is available for this article. Direct URL citations appear in the printed text and are available in both the HTML and PDF versions of this article. Links to the digital files are provided in the HTML text of this article on the Journal’s Web site (www.anesthesiology.org).×
  • Submitted for publication January 26, 2017. Accepted for publication June 12, 2017.
    Submitted for publication January 26, 2017. Accepted for publication June 12, 2017.×
  • *Members of the PeriOpeRative Tranexamic acid in hip arthrOplasty (PORTO) Study Group are listed in the appendix.
    Members of the PeriOpeRative Tranexamic acid in hip arthrOplasty (PORTO) Study Group are listed in the appendix.×
  • Acknowledgments: The authors are grateful to the following investigators who completed their data for the meta-analysis: Norio Imai, M.D., Department of Orthopedic Surgery, Niigata Prefectural Shibata Hospital, Shibata, Japan, and Borja Barrachina, M.D., Department of Anesthesia and Perioperative Care, Araba University Hospital, Vitoria-Gasteiz, Spain. The authors also thank Paula Harry, Ph.D., MediBridge SA, Vélizy, France, for revision of the English text.
    Acknowledgments: The authors are grateful to the following investigators who completed their data for the meta-analysis: Norio Imai, M.D., Department of Orthopedic Surgery, Niigata Prefectural Shibata Hospital, Shibata, Japan, and Borja Barrachina, M.D., Department of Anesthesia and Perioperative Care, Araba University Hospital, Vitoria-Gasteiz, Spain. The authors also thank Paula Harry, Ph.D., MediBridge SA, Vélizy, France, for revision of the English text.×
  • Research Support: Supported by the University Hospital of Saint-Etienne, France, the study sponsor.
    Research Support: Supported by the University Hospital of Saint-Etienne, France, the study sponsor.×
  • Competing Interests: All the authors except Dr. Borisov are employees of the funding source, which had no role in the design and conduct of the study; the collection, management, analysis, and interpretation of the data; the preparation, review, and approval of the manuscript; or the decision to submit the manuscript for publication.
    Competing Interests: All the authors except Dr. Borisov are employees of the funding source, which had no role in the design and conduct of the study; the collection, management, analysis, and interpretation of the data; the preparation, review, and approval of the manuscript; or the decision to submit the manuscript for publication.×
  • Reproducible Science: Full protocol available at: paul.zufferey@chu-st-etienne.fr. Raw data available at: paul.zufferey@chu-st-etienne.fr.
    Reproducible Science: Full protocol available at: paul.zufferey@chu-st-etienne.fr. Raw data available at: paul.zufferey@chu-st-etienne.fr.×
  • Correspondence: Address correspondence to Dr. Zufferey: University Hospital of Saint-Etienne, 42055 Saint-Etienne Cedex 02, France. paul.zufferey@chu-st-etienne.fr.Information on purchasing reprints may be found at www.anesthesiology.org or on the masthead page at the beginning of this issue. Anesthesiology’s articles are made freely accessible to all readers, for personal use only, 6 months from the cover date of the issue.
Article Information
Perioperative Medicine / Coagulation and Transfusion
Perioperative Medicine   |   July 2017
Intravenous Tranexamic Acid Bolus plus Infusion Is Not More Effective than a Single Bolus in Primary Hip Arthroplasty: A Randomized Controlled Trial
Anesthesiology Newly Published on July 10, 2017. doi:10.1097/ALN.0000000000001787
Anesthesiology Newly Published on July 10, 2017. doi:10.1097/ALN.0000000000001787
Abstract

Background: Preoperative administration of the antifibrinolytic agent tranexamic acid reduces bleeding in patients undergoing hip arthroplasty. Increased fibrinolytic activity is maintained throughout the first day postoperation. The objective of the study was to determine whether additional perioperative administration of tranexamic acid would further reduce blood loss.

Methods: This prospective, double-blind, parallel-arm, randomized, superiority study was conducted in 168 patients undergoing unilateral primary hip arthroplasty. Patients received a preoperative intravenous bolus of 1 g of tranexamic acid followed by a continuous infusion of either tranexamic acid 1 g (bolus-plus-infusion group) or placebo (bolus group) for 8 h. The primary outcome was calculated perioperative blood loss up to day 5. Erythrocyte transfusion was implemented according to a restrictive transfusion trigger strategy.

Results: The mean perioperative blood loss was 919 ± 338 ml in the bolus-plus-infusion group (84 patients analyzed) and 888 ± 366 ml in the bolus group (83 patients analyzed); mean difference, 30 ml (95% CI, −77 to 137; P = 0.58). Within 6 weeks postsurgery, three patients in each group (3.6%) underwent erythrocyte transfusion and two patients in the bolus group experienced distal deep-vein thrombosis. A meta-analysis combining data from this study with those of five other trials showed no incremental efficacy of additional perioperative administration of tranexamic acid.

Conclusions: A preoperative bolus of tranexamic acid, associated with a restrictive transfusion trigger strategy, resulted in low erythrocyte transfusion rates in patients undergoing hip arthroplasty. Supplementary perioperative administration of tranexamic acid did not achieve any further reduction in blood loss.