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Open Access Research article

A multi-center, prospective, open-label, 8-week study of certoparin for anticoagulation during maintenance hemodialysis – the membrane study

Oliver Dorsch1*, Detlef H Krieter2, Horst-Dieter Lemke3, Stefan Fischer4, Nima Melzer5, Christian Sieder5, Peter Bramlage6 and Job Harenberg7

Author Affiliations

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

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BMC Nephrology 2012, 13:50  doi:10.1186/1471-2369-13-50

Published: 28 June 2012

Abstract

Background

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.

Methods

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.

Results

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.

Conclusions

Certoparin appears effective and safe for anticoagulation in patients undergoing maintenance hemodialysis.