title: A multi-center, prospective, open-label, 8-week study of certoparin for anticoagulation during maintenance hemodialysis--the membrane study.
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.
authors: KfH Kuratorium für Dialyse und Nierentransplantation e,V,, KfH Nierenzentrum, Kronach, Germany. oliver.dorsch@kfh-dialyse.de
authors: Oliver
authors: O
authors: Dorsch
authors: Detlef H
authors: DH
authors: Krieter
authors: Horst-Dieter
authors: HD
authors: Lemke
authors: Stefan
authors: S
authors: Fischer
authors: Nima
authors: N
authors: Melzer
authors: Christian
authors: C
authors: Sieder
authors: Peter
authors: P
authors: Bramlage
authors: Job
authors: J
authors: Harenberg
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000925:Anticoagulants / Q000008:administration & dosage* / Q000009:adverse effects; D001778:Blood Coagulation Disorders / Q000097:blood / Q000517:prevention & control; D005260:Female; D006470:Hemorrhage / Q000097:blood / Q000139:chemically induced; D006495:Heparin, Low-Molecular-Weight / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D006435:Renal Dialysis / Q000009:adverse effects / Q000379:methods*; D051436:Renal Insufficiency, Chronic / Q000097:blood / Q000188:drug therapy* / Q000628:therapy; D013997:Time Factors
chemical_list: D000925:Anticoagulants; D006495:Heparin, Low-Molecular-Weight; C403769:certoparin