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JOURNAL ARTICLE
MULTICENTER STUDY
RANDOMIZED CONTROLLED TRIAL
Effect of Tranexamic Acid on Transfusion: A Randomized Clinical Trial in Acetabular Fracture Surgery.
Journal of Orthopaedic Trauma 2017 October
OBJECTIVES: Given the increasing evidence that minimizing blood loss and limiting allogeneic transfusion can improve patient outcome, we are performing a randomized controlled trial of the use of tranexamic acid (TXA) during acetabular fracture surgery.
DESIGN: Prospective, multicenter, and randomized.
SETTING: Two level I trauma centers.
PARTICIPANTS: Eighty-eight patients underwent randomization, with 42 assigned to the TXA group and 46 assigned to the placebo group.
INTERVENTION: The use of TXA during acetabular fracture surgery.
MAIN OUTCOME MEASUREMENTS: The primary outcome was allogeneic blood transfusion. Secondary outcomes consisted of estimate blood loss (EBL) and venous thromboembolism (VTE).
RESULTS: The overall transfusion rate was 40.9% (36 of 88), and the average estimated blood loss was 635 mL. There were no significant differences between groups for transfusion incidence, number of units transfused, EBL, or incidence of VTE. There was no difference in transfusion rate for the TXA group (0.097). Transfusion was significantly more likely in cases with low preoperative hemoglobin levels, higher rates of intraoperative blood loss, and longer surgical times.
CONCLUSIONS: There was no significant difference in transfusion rate, EBL, or VTE for TXA versus placebo. Any potential benefit seems to be overwhelmed by other factors, specifically preoperative anemia and surgical time, which are highly variable in trauma surgery. These findings do not support the routine use of TXA in the setting of open reduction and internal fixation of acetabular fractures.
LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.
DESIGN: Prospective, multicenter, and randomized.
SETTING: Two level I trauma centers.
PARTICIPANTS: Eighty-eight patients underwent randomization, with 42 assigned to the TXA group and 46 assigned to the placebo group.
INTERVENTION: The use of TXA during acetabular fracture surgery.
MAIN OUTCOME MEASUREMENTS: The primary outcome was allogeneic blood transfusion. Secondary outcomes consisted of estimate blood loss (EBL) and venous thromboembolism (VTE).
RESULTS: The overall transfusion rate was 40.9% (36 of 88), and the average estimated blood loss was 635 mL. There were no significant differences between groups for transfusion incidence, number of units transfused, EBL, or incidence of VTE. There was no difference in transfusion rate for the TXA group (0.097). Transfusion was significantly more likely in cases with low preoperative hemoglobin levels, higher rates of intraoperative blood loss, and longer surgical times.
CONCLUSIONS: There was no significant difference in transfusion rate, EBL, or VTE for TXA versus placebo. Any potential benefit seems to be overwhelmed by other factors, specifically preoperative anemia and surgical time, which are highly variable in trauma surgery. These findings do not support the routine use of TXA in the setting of open reduction and internal fixation of acetabular fractures.
LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.
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