Paul J Zufferey1, Julien Lanoiselée, Céline Chapelle, Dmitry B Borisov, Jean-Yves Bien, Pierre Lambert, Rémi Philippot, Serge Molliex, Xavier Delavenne. 1. 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.
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.
RCT Entities:
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.
Authors: Shahid Miangul; Timothy Oluwaremi; Joe El Haddad; Maamoun Adra; Nathan Pinnawala; Hayato Nakanishi; Reem H Matar; Christian A Than; Thomas M Stewart Journal: Eur J Orthop Surg Traumatol Date: 2022-09-26
Authors: J Lanoiselée; R Chaux; S Hodin; S Bourayou; A Gibert; R Philippot; S Molliex; P J Zufferey; X Delavenne; E Ollier Journal: Sci Rep Date: 2021-10-05 Impact factor: 4.379