title: Safety of fondaparinux for prevention of postoperative venous thromboembolism in urological malignancy: A prospective randomized clinical trial.
abstract: To prospectively evaluate the safety of postoperative fondaparinux in comparison with low molecular weight heparin in patients undergoing uro-oncological surgery.
  
  
  
  The present study was a prospective, single-blind, non-inferiority randomized trial. A total of 359 patients undergoing surgery for urological malignancy were enrolled from January 2011 to December 2012. A total of 298 of these patients (fondaparinux group, 152; low molecular weight heparin group, 146) were evaluable for the intention-to-treat-analysis. Patients were randomly assigned to low-dose unfractionated heparin, 5000 units twice daily until postoperative day 1 plus either fondaparinux 2.5 mg once daily or low molecular weight heparin 2000 units twice daily until postoperative day 5. The primary end-point was postoperative bleeding as by independent review, and the study was powered to show the non-inferiority of fondaparinux versus low molecular weight heparin. The other adverse events were evaluated. D-dimer and soluble fibrin monomer complex levels were measured perioperatively.
  
  
  
  Bleeding occurred in 21 patients (12 in the fondaparinux group and 9 in low molecular weight heparin group, respectively). No significant differences were detected in the incidence of postoperative bleeding and the other adverse events between the two groups. The D-dimer was elevated on postoperative day 1 in one patient (16.6 μg/mL). In another patient, the soluble fibrin monomer complex was elevated (109 μg/mL).
  
  
  
  Fondaparinux is non-inferior to low molecular weight heparin with respect to risk of bleeding. The favorable safety profile of fondparinux supports its prophylactic use as an alternative to low molecular weight heparin after surgery for urological malignancy.
authors.affiliation: Department of Urology, Jikei University School of Medicine, Tokyo, Japan. hataken1@jikei.ac.jp.
authors.forename: Kenichi
authors.initials: K
authors.lastname: Hata
authors.affiliation: Department of Urology, Jikei University School of Medicine, Tokyo, Japan.
authors.forename: Takahiro
authors.initials: T
authors.lastname: Kimura
authors.affiliation: Department of Urology, Jikei University School of Medicine, Tokyo, Japan.
authors.forename: Shunsuke
authors.initials: S
authors.lastname: Tsuzuki
authors.affiliation: Department of Urology, Jikei University School of Medicine, Tokyo, Japan.
authors.forename: Gen
authors.initials: G
authors.lastname: Ishii
authors.affiliation: Department of Urology, Jikei University School of Medicine, Tokyo, Japan.
authors.forename: Masahito
authors.initials: M
authors.lastname: Kido
authors.affiliation: Department of Urology, Jikei University School of Medicine, Tokyo, Japan.
authors.forename: Toshihiro
authors.initials: T
authors.lastname: Yamamoto
authors.affiliation: Department of Urology, Jikei University School of Medicine, Tokyo, Japan.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Sasaki
authors.affiliation: Department of Urology, Jikei University School of Medicine, Tokyo, Japan.
authors.forename: Jun
authors.initials: J
authors.lastname: Miki
authors.affiliation: Department of Urology, Jikei University School of Medicine, Tokyo, Japan.
authors.forename: Hiroki
authors.initials: H
authors.lastname: Yamada
authors.affiliation: Department of Urology, Jikei University School of Medicine, Tokyo, Japan.
authors.forename: Akira
authors.initials: A
authors.lastname: Furuta
authors.affiliation: Department of Urology, Jikei University School of Medicine, Tokyo, Japan.
authors.forename: Kenta
authors.initials: K
authors.lastname: Miki
authors.affiliation: Department of Urology, Jikei University School of Medicine, Tokyo, Japan.
authors.forename: Shin
authors.initials: S
authors.lastname: Egawa
mesh_terms: D000925:Anticoagulants / Q000627:therapeutic use*; D000077425:Fondaparinux; D006493:Heparin / Q000627:therapeutic use; D006801:Humans; D011134:Polysaccharides / Q000627:therapeutic use*; D011183:Postoperative Complications; D011446:Prospective Studies; D016037:Single-Blind Method; D014571:Urologic Neoplasms / Q000601:surgery*; D054556:Venous Thromboembolism / Q000517:prevention & control*
chemical_list: D000925:Anticoagulants; D011134:Polysaccharides; D006493:Heparin; D000077425:Fondaparinux
keywords: fondaparinux; thromboprophylaxis; urological malignancy; urological surgery; venous thromboembolism