Individualized anticoagulation with dermatan sulphate for haemodialysis in chronic renal failure |
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Authors: | Boccardo P; Melacini D; Rota S; Mecca G; Boletta A; Casiraghi F; Gianese F |
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Institution: | Mario Negri Institute for Pharmacological Research, Villa Camozzi, I-24020 Ranica, Bergamo, Italy; Division of Nephrology and Dialysis, Azienda Ospedaliera Ospedali Riuniti, Bergamo, Italy; Medical Department, Mediolanum Farmaceutici, Milano, Italy; Corresponding author |
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Abstract: | Background: Dermatan sulphate (DS) is a selective
thrombin inhibitor with antithrombotic properties and low bleeding
potential. In preliminary studies it was reported to be effective for
preventing clot formation in the haemodialysis circuit.
Methods: Ten patients on maintenance haemodialysis for
chronic renal failure underwent three consecutive investigation phases. In
phase 1 (individual dose titration), repeated dialyses were preformed with
increasing doses of DS until successful dialysis was obtained in two
sessions at the same dose. In phase 2, individualized DS doses were
validated by a randomized crossover comparison with the individual heparin
dose of each patient. In phase 3, each patient underwent 24 consecutive
dialyses with DS over 8 weeks. Successful dialysis was defined as
completion of the procedure without visible clot formation in the bubble
traps and lines or a greater than 20% decrease in dialyser capacity.
Dialysis efficiency (decrease in serum urea and creatinine, Kt/V), APTT
prolongation, bleeding time, and DS plasma concentrations were also
assessed. Results: Phase 1: successful dialysis was
achieved in nine patients with 4 mg/kg DS as a predialysis intravenous
bolus followed by continuous infusion of 0.65 mg/kg/h. One patient required
5 mg/kg plus 1.3 mg/kg/h. Phase 2: no statistically significant differences
were found between DS and heparin in any of the investigated variables.
Residual dialyser capacity and dialysis efficiency indexes indicated
equivalent efficacy. Phase 3: residual dialyser capacity and dialysis
efficiency did not change with time. There was no accumulation of DS in
plasma. No bleeding or thrombocytopenia were observed.
Conclusions: The dose of DS can be individually
titrated to suppress clot formation during haemodialysis as efficiently as
with individualized heparin. Such an individualized DS regimen maintains
its anticoagulant efficacy and is safe in prolonged use. Key
words: anticoagulation; clinical trial; dermatan sulphate;
haemodialysis; heparin
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