A multi-center, prospective, open-label, 8-week study of certoparin for anticoagulation during maintenance hemodialysis - The membrane study
BMC Nephrology, ISSN: 1471-2369, Vol: 13, Issue: 1, Page: 50
2012
- 13Citations
- 25Captures
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Metrics Details
- Citations13
- Citation Indexes13
- 13
- CrossRef4
- Captures25
- Readers25
- 25
Article Description
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. C was 0.01 [0.01-0.02] aXa IU at all visits. At baseline and 4 weeks AUC 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. © 2012 Dorsch et al.; licensee BioMed Central Ltd.
Bibliographic Details
http://www.scopus.com/inward/record.url?partnerID=HzOxMe3b&scp=84862753214&origin=inward; http://dx.doi.org/10.1186/1471-2369-13-50; https://clinicaltrials.gov/ct2/show/NCT01179620; http://www.ncbi.nlm.nih.gov/pubmed/22742742; https://bmcnephrol.biomedcentral.com/articles/10.1186/1471-2369-13-50; https://dx.doi.org/10.1186/1471-2369-13-50
Springer Nature
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