Document Detail


CERTIFY: prophylaxis of venous thromboembolism in patients with severe renal insufficiency.
MedLine Citation:
PMID:  21505722     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
Patients with severe renal insufficiency (sRI) have been suggested to be at an increased risk of bleeding with low-molecular-weight heparins (LMWH). We aimed at assessing the benefits and risks of certoparin in comparison to unfractionated heparin (UFH) in these patients. In this subgroup analysis of the CERTIFY trial, acutely ill, non-surgical patients ≥70 years received certoparin 3,000U aXa o.d. or UFH 5,000 IU t.i.d. One hundred eighty-nine patients had a glomerular filtration rate (GFR) ≤30 ml/min/1.73 m2, 3,050 patients served as controls. Patients with sRI had a mean age of 85.9 ± 6.6 years (controls 78.4 ± 6.0) and were treated for a mean of 9.3 ± 3.7 days (9.9 ± 4.3). Thromboembolic event rates were comparable (4.55 vs. 4.21%; OR1.08; 95%CI 0.5-2.37) but bleeding was increased in sRI (9.52 vs. 3.54%; OR2.87; 95%CI 1.70-4.83). The incidence of the combined end-point of proximal DVT, symptomatic non-fatal PE and VTE related death was 6.49% with certoparin and 2.60% with UFH (OR2.60; 95%CI 0.49-13.85). There was a decrease in total bleeding with certoparin (OR0.33; 95%CI 0.11-0.97), which was non-significant in patients with GFR >30 ml/min/1.73 m2. In two multivariable regression models certoparin and immobilisation <10 days were associated with less bleeding while a GFR ≤30 ml/min/1.73 m2 was associated with increased bleeding. A total of 11.3% of certoparin- and 18.5% of UFH-treated patients experienced serious adverse events (14.8 in patients with a GFR ≤30 vs. 5.6% vs. >30 ml/min/1.73 m2). In conclusion, certoparin 3,000U anti Xa o.d. was as efficacious as 5,000 IU UFH t.i.d. in patients with sRI but had a reduced risk of bleeding.
Authors:
R Bauersachs; S M Schellong; S Haas; U Tebbe; H-E Gerlach; C Abletshauser; C Sieder; N Melzer; P Bramlage; H Riess
Publication Detail:
Type:  Clinical Trial; Comparative Study; Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't     Date:  2011-04-20
Journal Detail:
Title:  Thrombosis and haemostasis     Volume:  105     ISSN:  0340-6245     ISO Abbreviation:  Thromb. Haemost.     Publication Date:  2011 Jun 
Date Detail:
Created Date:  2011-06-07     Completed Date:  2011-10-27     Revised Date:  2012-01-10    
Medline Journal Info:
Nlm Unique ID:  7608063     Medline TA:  Thromb Haemost     Country:  Germany    
Other Details:
Languages:  eng     Pagination:  981-8     Citation Subset:  IM    
Affiliation:
Medizinische Klinik IV, Max-Ratschow-Klinik für Angiologie, Klinikum Darmstadt GmbH, Grafenstraße 9, 64283 Darmstadt, Germany. bauersachs@em.uni-frankfurt.de
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00451412
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MeSH Terms
Descriptor/Qualifier:
Acute Kidney Injury / blood,  drug therapy*,  epidemiology
Aged
Aged, 80 and over
Anticoagulants / administration & dosage*,  adverse effects
Female
Germany
Hemorrhage / etiology,  prevention & control
Heparin / administration & dosage,  adverse effects
Heparin, Low-Molecular-Weight / administration & dosage*,  adverse effects
Humans
Incidence
Male
Risk Assessment
Venous Thromboembolism / prevention & control
Chemical
Reg. No./Substance:
0/Anticoagulants; 0/Heparin, Low-Molecular-Weight; 0/certoparin; 9005-49-6/Heparin

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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