An Adjustable Dalteparin Sodium Dose Regimen for the Prevention of Clotting in the Extracorporeal Circuit in Hemodialysis: A Clinical Trial of Safety and Efficacy (the PARROT Study):

Background:Dalteparin sodium, a low-molecular-weight heparin, is indicated for prevention of clotting in the extracorporeal circuit during hemodialysis (HD). Product labeling recommends a fixed single-bolus dose of 5000 international units (IU) for HD sessions lasting up to 4 hours, but adjustable dosing may be beneficial in clinical practice.Objective:The aim of the PARROT study was to investigate the safety and efficacy of an adjustable dose of dalteparin in patients with end-stage renal disease requiring 3 to 4 HD sessions per week.Design:A 7-week, open-label, multicenter study with a single treatment arm, conducted between October 2013 and March 2016.Setting:Ten sites in Canada.Patients:A total of 152 patients with end-stage renal disease requiring 3 to 4 HD sessions per week.Measurements:The primary outcome was the proportion of HD sessions completed without premature termination due to inadequate anticoagulation.Methods:All participants initially received a dose of 5000 IU dalteparin, which could be...