A multi-center, prospective, open-label, 8-week study of certoparin for anticoagulation during maintenance hemodialysis – the membrane study
1 KfH Kuratorium für Dialyse und Nierentransplantation e.V., KfH Nierenzentrum, Friesener Straße 37a, 96317, Kronach, Germany
2 Universitätsklinik Würzburg, Nephrologie, Würzburg, Germany
3 EXcorLab GmbH, Obernburg, Germany
4 Dialyse Centrum Darmstadt, Darmstadt, Germany
5 Novartis Pharma GmbH, Nürnberg, Germany
6 Institut für Pharmakologie und präventive Medizin, Mahlow, Germany
7 Klinische Pharmakologie Mannheim, Ruprecht-Karls-Universität Heidelberg, Mannheim, Germany
BMC Nephrology 2012, 13:50 doi:10.1186/1471-2369-13-50Published: 28 June 2012
Adequate anticoagulation is prerequisite for effective hemodialysis to prevent clotting in the extracorporeal circuit. We aimed providing first data on the efficacy and safety of the low-molecular-weight heparin certoparin in this setting.
Multicenter, open-label, 8-week trial. Patients received a single dose of 3,000 IU certoparin i.v. with additional titration steps of 600 IU and/or continuous infusion if necessary.
120 patients were screened, 109 enrolled (median age 71; range 26–90 years) and 106 available for efficacy analyses. The percentage of unsatisfactory dialysis results at 8 weeks due to clotting or bleeding, was 1.9% (n = 2/106; 95% confidence interval [CI] 0.23–6.65%); no major bleeding. 1.9% had moderate/severe clotting in the lines/bubble catcher and 2.8% in the dialyser at week 8. 15.7 ± 14.3% of the dialysis filters’ visual surface area was showing redness. In subgroups of patients receiving median doses of 3000 ± 0, 3000 (2400–6000) and 4200 (3000–6600) IU, plasma aXa levels at baseline, 4 and 8 weeks were 0.24 [95%CI 0.21–0.27], 0.33 [0.27–0.40] and 0.38 [0.33–0.45] aXa IU/ml at 2 h. C48h was 0.01 [0.01–0.02] aXa IU at all visits. At baseline and 4 weeks AUC0-48h was 2.66 [2.19–3.24] and 3.66 [3.00–4.45] aXa IU*h/ml. In 3.0% of dialyses (n = 83/2724) prolonged fistula compression times were documented. Eight patients (7.34%) had at least one episode of minor bleeding. 4) 85.3% of patients had any adverse event, 9.2% were serious without suspected drug relation; and in 32 patients a drug-relation was suspected.
Certoparin appears effective and safe for anticoagulation in patients undergoing maintenance hemodialysis.