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

• Verfasst von: Dorsch, Oliver Kurt [VerfasserIn]
• Verfasst von: Harenberg, Job [VerfasserIn]
• Titel: A multi-center, prospective, open-label, 8-week study of certoparin for anticoagulation during maintenance hemodialysis - the membrane study
• Verf.angabe: Oliver Dorsch, Detlef H Krieter, Horst-Dieter Lemke, Stefan Fischer, Nima Melzer, Christian Sieder, Peter Bramlage and Job Harenberg
• E-Jahr: 2012
• Jahr: 28 June 2012
• Umfang: 10 S.
• Fussnoten: Gesehen am 08.08.2018
• Titel Quelle: Enthalten in: BMC nephrology
• Ort Quelle: London : BioMed Central, 2000
• Jahr Quelle: 2012
• Band/Heft Quelle: 13(2012), Artikel-ID 50, Seite 1-10
• ISSN Quelle: 1471-2369
• DOI: doi:10.1186/1471-2369-13-50
• Datenträger: Online-Ressource
• Sprache: eng
• K10plus-PPN: 1578358698

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.