%0 Journal Article
%T A multi-center, prospective, open-label, 8-week study of certoparin for anticoagulation during maintenance hemodialysis 每 the membrane study
%A Oliver Dorsch
%A Detlef H Krieter
%A Horst-Dieter Lemke
%A Stefan Fischer
%A Nima Melzer
%A Christian Sieder
%A Peter Bramlage
%A Job Harenberg
%J BMC Nephrology
%D 2012
%I BioMed Central
%R 10.1186/1471-2369-13-50
%X 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每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% (nˋ=ˋ2/106; 95% confidence interval [CI] 0.23每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. 15.7ˋ㊣ˋ14.3% of the dialysis filters＊ visual surface area was showing redness. In subgroups of patients receiving median doses of 3000ˋ㊣ˋ0, 3000 (2400每6000) and 4200 (3000每6600) IU, plasma aXa levels at baseline, 4 and 8 weeks were 0.24 [95%CI 0.21每0.27], 0.33 [0.27每0.40] and 0.38 [0.33每0.45] aXa IU/ml at 2 h. C48h was 0.01 [0.01每0.02] aXa IU at all visits. At baseline and 4 weeks AUC0-48h was 2.66 [2.19每3.24] and 3.66 [3.00每4.45] aXa IU*h/ml. In 3.0% of dialyses (nˋ=ˋ83/2724) 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.
%U http://www.biomedcentral.com/1471-2369/13/50/abstract