Objectives: We aimed to determine whether (1) tranexamic acid (TXA) reduces the incidence of transfusion (2) TXA reduces the calculated blood loss, and (3) there are any observable differences in 30- and 90-day complications with TXA administration during arthroplasty for femoral neck fracture (FNF).
Design: Prospective, double-blinded, randomized controlled trial.
Setting: Level 1 Academic Trauma Center.
Patients/Participants: One hundred thirty-eight patients who presented with a low-energy, isolated, FNF (AO 31B) treated with either hemi- or total hip arthroplasty within 72 hours of injury were randomized to either the TXA group (69 patients) or placebo group (69 patients).
Intervention: In the TXA group, patients received 2 doses of 15 mg/kg intravenous TXA dissolved in 100 mL of saline, each administered over 10 minutes; 1 dose just before incision, and the second at wound closure. In the placebo group, 100 mL of saline solution was administered in a similar fashion. Perioperative care was otherwise standardized including conservative transfusion criteria.
Main Outcome Measurements: Our primary outcome was to determine the proportion of patients who underwent blood transfusion during hospitalization. Secondary outcomes were calculated blood loss, number of units transfused during hospitalization, and incidence of adverse events at 30 and 90 days including thromboembolic event, wound complications, reoperation, hospital readmission, and all-cause mortality.
Results: TXA reduced mean incidence of transfusion by 305 mL (P = 0.0005). There was a trend toward decreased transfusion rate in the TXA group (17% vs. 26%, P = 0.22). TXA was safe with no differences in adverse events at 30 and 90 days.
Conclusions: This randomized clinical trial found that TXA administration safely reduced blood loss with a tendency for decreased transfusion rate and total blood product consumption for patients undergoing hip arthroplasty for acute FNF. More studies are needed to further ascertain the role of TXA in the management of patients with FNF.
Level of Evidence: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.
Department of Orthopedic Surgery, Mayo Clinic, Rochester, MN.
Reprints: Chad D. Watts, MD, Department of Orthopedic Surgery, Mayo Clinic, 200 First St SW, Rochester, MN 55905 (e-mail: chaddwatts@gmail.com).
Supported by Zimmer (Warsaw, IN), Stryker (Mahwah, NJ), DePuy (Warsaw, IN), and Biomet (Warsaw, IN).
M. W. Pagnano has consulted for, or has received royalties from, DePuy (Warsaw, IN), Stryker (Mahwah, NJ), and Pacira (Parsippany, NJ). S. A. Sems consults for or has received royalties from Biomet (Warsaw, IN). The remaining authors report no conflict of interest.
Presented in part at the at AAHKS, November 6, 2015, Dallas, TX; the Annual Meeting of the American Academy of Orthopaedic Surgeons, March 2, 2016, Orlando, FL; the Mid-America Orthopaedic Association, April 15, 2016, Bonita Springs, FL; and the Annual Meeting of the Orthopaedic Trauma Association, October 6, 2016, National Harbor, MD.
IRB #12-004599; Clinical Trials # NCT01714336.
Each author certifies that his or her institution approved the human protocol for this investigation and that all investigations were conducted in conformity with ethical principles of research.
Accepted February 24, 2017
