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ÁCIDO TRANEXÁMICO EN REEMPLAZO DE CADERA: HACER POCO PARECIERA SER SUFICIENTE.......

Intravenous Tranexamic Acid Bolus plus Infusion Is Not More Effective than a Single Bolus in Primary Hip Arthroplasty: A Randomized Controlled Trial

Paul J. Zufferey, M.D., Ph.D.; Julien Lanoiselée, M.B.B.S.; Céline Chapelle, M.Sc.; Dmitry B. Borisov, M.D.; Jean-Yves Bien, M.D.; Pierre Lambert, M.D.; Rémi Philippot, M.D., Ph.D.; Serge Molliex, M.D., Ph.D.; Xavier Delavenne, Pharm.D., Ph.D.

[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.).]


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.


COMENTARIOS:  Este artículo se suma a la evidencia creciente sobre el pobre efecto adicional de complementar el bolo inicial de ácido tranexámico con una infusión posterior (muchos de los esquemas institucionales actuales consideran esta práctica como un estándar).  Analizando la metodología de este estudio se observa que los grupos estudiados fueron equiparables en sus características de base y en sus procedimientos son reproducibles y extrapolables.  A pesar de lo anterior, los autores expresan que ya que más de un 90% de los pacientes recibieron anestesia general (potencial relación con mayor liberación de inhibir del plasminógeno tisular tipo 1), sus datos podrían no ser equiparables a los de centros en donde se utilizan más frecuentemente abordajes neuroaxiales.  Como dato curioso, este estudio también combina sus propios resultados con los de 5 estudios previos para realizar adicionalmente un metaanálisis que muestra que bajo un modelo de efectos mixtos o aleatorios, es muy probable que exista futilidad al mantener una infusión de ácido tranexámico sobre la cantidad de sangrado postoperatorio.



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