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 adjusted at subsequent HD sessions when clinically indicated, by
increment or decrement of 500 or 1000 IU, with no specified dose limits.Results:Patients were followed for 256 patient-months. Nearly all (99.9%; 95%
confidence interval [CI]: 99.7-100) evaluable HD sessions were completed
without premature clotting. Dose was adjusted for more than half (52.3%) of
participants, mostly owing to clotting or access compression time >10
minutes. Median dalteparin dose was 5000 IU (range: 500-13 000 IU). There
were no major bleeds, and minor bleeding was reported in 2.3% of all HD
sessions. There was no evidence of bioaccumulation.Limitations:This short-term study, with a single treatment arm, was designed to optimize
dalteparin dose using a flexible dosing schedule; it was not designed to
specifically evaluate dalteparin dose minimization, provide a direct
comparison of dalteparin versus unfractionated heparin, or provide
information on long-term safety for flexible dalteparin dosing. Patients
were excluded if they were at high risk of bleeding, including those on
anticoagulants and those on antiplatelet agents other than aspirin <100
mg/d.Conclusions:Overall, an adjustable dalteparin sodium dose regimen allowed safe completion
of HD, with clinical benefits over fixed dosing.Trial Registration:ClinicalTrials.gov NCT01879618, registered June 13,
2013.