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Anesthesia and analgesia · Apr 2016
Randomized Controlled Trial Multicenter Study Comparative StudyTranexamic Acid Compared with Placebo for Reducing Total Blood Loss in Hip Replacement Surgery: A Randomized Clinical Trial.
- Borja Barrachina, Amanda Lopez-Picado, Maria Remon, Ana Fondarella, Ibai Iriarte, Rebeca Bastida, Alicia Rodríguez-Gascón, Maria Aranzazu Achaerandio, Maria Carmen Iturricastillo, Felipe Aizpuru, Cesar Augusto Valero, Ricardo Tobalina, and Roberto Hernanz.
- From the *Department of Anaesthesia and Perioperative Care, Araba University Hospital, Vitoria-Gasteiz, Spain; †Araba Research Unit, Araba University Hospital, Vitoria-Gasteiz, Spain; ‡Department of Anaesthesia and Perioperative Care, Garcia Orcoyen Hospital, Estella, Spain; §Department of Radiology, Araba University Hospital, Vitoria-Gasteiz, Spain; ‖Pharmacy and Pharmaceutical Technology, University of the Basque Country UPV/EHU, Vitoria-Gasteiz, Spain; ¶Central Laboratory, Araba University Hospital, Vitoria-Gasteiz, Spain; #Department of Orthopaedic Surgery and Trauma, Araba University Hospital, Vitoria-Gasteiz, Spain; and **Pharmacy Service, Araba University Hospital, Vitoria-Gasteiz, Spain.
- Anesth. Analg. 2016 Apr 1; 122 (4): 986-95.
BackgroundTranexamic acid (TXA) reduces bleeding in patients undergoing hip replacement surgery, but optimal doses and timing have yet to be established. Our primary objective in this study was to assess total blood loss 48 hours after surgery with different regimens.MethodsThis was a multicenter, parallel-group, randomized, placebo-controlled clinical trial that included all ASA physical status I to III patients undergoing unilateral total hip replacement surgery who met the inclusion criteria. Patients were randomly allocated to 1 of 3 groups: a single-dose group (15 mg/kg TXA before the start of surgery and saline 3 hours later after the start of surgery), a 2-dose group (10 m/kg TXA before and 10 mg/kg of TXA 3 hours after the start of surgery), and a control group (saline before and 3 hours after the start of surgery). Total blood loss was calculated using a formula considering hematocrit values and blood transfusions received.ResultsWe included 108 patients in the study. Total blood loss volumes up to day 2 were 1377 ± 689, 1308 ± 641, and 2215 ± 1136 mL in the single-dose, 2-dose and control groups, respectively (P < 0.001 between the placebo and the experimental groups). Blood transfusions were given to 22.9% of patients (n = 8) in the single-dose group, 11.1% (n = 4) in the 2-dose group, and 37.8% (n = 14) in the control group (P = 0.028).ConclusionsA single preoperative dose of TXA or 2 infusions of a lower dose, preoperatively and then after 3 hours after the start of surgery, resulted in lower blood loss during the first 2 days after surgery and less need for blood transfusion, with good levels of safety.
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