Tranexamic acid versus aminocapróic acid in multiple doses via the oral route for the reduction of postoperative bleeding in total primary hip arthroplasty: a prospective, randomized, double-blind, controlled study

研究概要

One hundred and two patients scheduled to undergo an elective cementless primary unilateral total hip arthroplasty (THA) to treat either osteoarthritis, osteonecrosis of femoral head or developmental dysplasia of hip were randomized to receive either oral tranexamic acid (TXA) or oral epsilon-aminocaproic acid (EACA) which were both administered pre-operatively (2h pre-incision) and at 6 and 12 hours post-surgery. Primary outcomes included total blood loss (TBL), hidden blood loss (HBL), rate of transfusion, and external blood loss (EBL). Secondary outcomes of interest included the following: internal blood loss (IBL), drop in hemoglobin and hematocrit levels, drain output, incidence of readmission, incidence of mortality, pain measured using the Visual Analogue Scale (VAS), incidence of complications and adverse events, range of motion, and function evaluated using the Harris hip score (HHS). VAS pain and HHS scores were measured at 3, 7, and 30 days post-surgery. Results revealed no statistical significant differences between TXA and EACA groups for all outcomes at all timepoints (p>0.05 for all). 3 patients in the EACA group and 1 patient in the TXA group received transfusions (p>0.05). No patients were observed to be re-admitted at 90 days and mortality rate was zero at 30 days follow-up. A total of 9 and 7 adverse events and complications were observed in the TXA and EACA groups, respectively, with no statistical significant difference between the 2 groups (p=0.711).