Prospective, randomized trial to evaluate efficacy of a thrombin-based hemostatic agent in total knee arthroplasty

J Arthroplasty. 2014 Oct;29(10):1950-5. doi: 10.1016/j.arth.2014.05.025. Epub 2014 Jun 5.

Abstract

Total knee arthroplasty (TKA) can be associated with substantial blood loss, leading to increased morbidity and transfusion rates. The study objective was to evaluate routine use of a thrombin-based topical hemostatic matrix in reducing blood loss and transfusion requirements in primary TKA. 108 patients were enrolled in a prospective, randomized, single-center trial. Patients receiving the hemostatic agent demonstrated a lower mean calculated blood loss (1325.2±464.8mL vs. control, 1509.3±432.8mL; P=0.02), drain output (415.6±202.0mL vs. control, 579.9±306.7mL; P=0.008), and length of stay (3.3±0.8days vs. control, 3.7±1.1days; P=0.03), without a statistically significant difference in mean hemoglobin loss or transfusion requirements. The clinical utility of this hemostatic agent to reduce transfusions after uncomplicated, primary TKA continues to remain unclear.

Keywords: Floseal; Total knee arthroplasty; blood conservation; blood management; hemostatic agent; transfusion.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Administration, Topical
  • Adult
  • Aged
  • Aged, 80 and over
  • Arthritis / surgery
  • Arthroplasty, Replacement, Knee* / adverse effects
  • Blood Loss, Surgical / prevention & control*
  • Blood Transfusion
  • Female
  • Gelatin Sponge, Absorbable / administration & dosage*
  • Hemostatics / administration & dosage*
  • Humans
  • Knee Joint / surgery
  • Male
  • Middle Aged
  • Postoperative Hemorrhage / etiology
  • Postoperative Hemorrhage / prevention & control*
  • Prospective Studies
  • Thrombin / administration & dosage*
  • Treatment Outcome

Substances

  • FloSeal Matrix
  • Hemostatics
  • Thrombin