title: Topical and intravenous tranexamic acid reduce blood loss compared to routine hemostasis in total knee arthroplasty: a multicenter, randomized, controlled trial.
abstract: BACKGROUND
  Tranexamic acid (TXA) is becoming widely used in orthopedic surgery to reduce blood loss and transfusion requirements, but consensus is lacking regarding the optimal route and dose of administration. The aim of this study was to compare the efficacy and safety of topical and intravenous routes of TXA with routine hemostasis in patients undergoing primary total knee arthroplasty (TKA).
  
  
  METHODS
  We performed a randomized, multicenter, parallel, open-label clinical trial in adult patients undergoing primary TKA. Patients were divided into three groups of 50 patients each: Group 1 received 1 g topical TXA, Group 2 received 2 g intravenous TXA, and Group 3 (control group) had routine hemostasis. The primary outcome was total blood loss. Secondary outcomes were hidden blood loss, blood collected in drains, transfusion rate, number of blood units transfused, adverse events, and mortality.
  
  
  RESULTS
  One hundred and fifty patients were included. Total blood loss was 1021.57 (481.09) mL in Group 1, 817.54 (324.82) mL in Group 2 and 1415.72 (595.11) mL in Group 3 (control group). Differences in total blood loss between the TXA groups and the control group were clinically and statistically significant (p < 0.001). In an exploratory analysis differences between the two TXA groups were not statistically significant (p = 0.073) Seventeen patients were transfused. Transfusion requirements were significantly higher in Group 3 (p = 0.005). No significant differences were found between groups regarding adverse events.
  
  
  CONCLUSIONS
  We found that 1 g of topical TXA and 2 g of intravenous TXA were both safe strategies and more effective than routine hemostasis to reduce blood loss and transfusion requirements after primary TKA.
  
  
  METHODS
  I.
authors.affiliation: Orthopedic Surgery and Traumatology Department, Hospital de la Santa Creu i Sant Pau, Sant Antoni Mª Claret 167, 08025, Barcelona, Spain.
authors.forename: X
authors.initials: X
authors.lastname: Aguilera
authors.forename: M J
authors.initials: MJ
authors.lastname: Martínez-Zapata
authors.forename: P
authors.initials: P
authors.lastname: Hinarejos
authors.forename: M
authors.initials: M
authors.lastname: Jordán
authors.forename: J
authors.initials: J
authors.lastname: Leal
authors.forename: J C
authors.initials: JC
authors.lastname: González
authors.forename: J C
authors.initials: JC
authors.lastname: Monllau
authors.forename: F
authors.initials: F
authors.lastname: Celaya
authors.forename: A
authors.initials: A
authors.lastname: Rodríguez-Arias
authors.forename: J A
authors.initials: JA
authors.lastname: Fernández
authors.forename: X
authors.initials: X
authors.lastname: Pelfort
authors.forename: L l
authors.initials: Ll
authors.lastname: Puig-Verdie
mesh_terms: D000279:Administration, Cutaneous; D000368:Aged; D000369:Aged, 80 and over; D000933:Antifibrinolytic Agents / Q000008:administration & dosage*; D019645:Arthroplasty, Replacement, Knee / Q000379:methods*; D016063:Blood Loss, Surgical / Q000517:prevention & control; D005260:Female; D006487:Hemostasis; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D019106:Postoperative Hemorrhage / Q000517:prevention & control; D013030:Spain; D014148:Tranexamic Acid / Q000008:administration & dosage*; D016896:Treatment Outcome
chemical_list: D000933:Antifibrinolytic Agents; D014148:Tranexamic Acid