Document Detail


The safety and efficacy of extended thromboprophylaxis with fondaparinux after major orthopedic surgery of the lower limb with or without a neuraxial or deep peripheral nerve catheter: the EXPERT Study.
MedLine Citation:
PMID:  18042845     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: The benefit-risk ratio of extended fondaparinux therapy has not been assessed in patients undergoing major lower limb joint arthroplasty. Few data on the concomitant use of fondaparinux and continuous neuraxial or deep peripheral nerve blockade are available. We performed a prospective intervention study in patients undergoing major orthopedic surgery primarily designed to assess the efficacy of fondaparinux when drug administration was withheld for 48 h to permit removal of a neuraxial or deep peripheral nerve catheter. The safety and efficacy of extended fondaparinux therapy for the prevention of venous thromboembolism were also evaluated. METHODS: Patients received a daily subcutaneous injection of 2.5 mg fondaparinux for 3 to 5 wk postoperatively. In patients with a neuraxial or deep peripheral nerve catheter, the catheter was removed 36 h after the last fondaparinux dose. The next fondaparinux dose was administered 12 h after catheter removal. The primary end points were symptomatic venous thromboembolism and major bleeding up to 4-6 wk after surgery. RESULTS: We recruited 5704 patients. A neuraxial or deep peripheral nerve catheter was inserted in 1553 (27%) patients and 78 (1.4%) patients, respectively. The rate of venous thromboembolism was 1.0% (54 of 5387). There was no difference between patients without (1.1%) or with (0.8%) a catheter (the upper limit of the 95% confidence interval of the odds ratio, 1.49, being below the predetermined noninferiority margin of 1.75). The incidence of major bleeding was 0.8% (42 of 5382). No neuraxial or perineural hematoma was reported. CONCLUSIONS: Once-daily subcutaneous injection of 2.5 mg fondaparinux given for 3 to 5 wk was effective and safe for prevention of venous thromboembolism after major orthopedic surgery. Temporary discontinuation of fondaparinux for 48 h permitted safe removal of a neuraxial or deep peripheral nerve catheter without decreasing thromboprophylatic efficacy.
Authors:
François J Singelyn; Cees C P M Verheyen; Franco Piovella; Hugo K Van Aken; Nadia Rosencher;
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Publication Detail:
Type:  Clinical Trial; Comparative Study; Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Anesthesia and analgesia     Volume:  105     ISSN:  1526-7598     ISO Abbreviation:  Anesth. Analg.     Publication Date:  2007 Dec 
Date Detail:
Created Date:  2007-11-28     Completed Date:  2007-12-20     Revised Date:  2009-02-09    
Medline Journal Info:
Nlm Unique ID:  1310650     Medline TA:  Anesth Analg     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1540-7, table of contents     Citation Subset:  AIM; IM    
Affiliation:
Department of Anesthesiology, Clinical Center, Soyaux, France. francois.singelyn@orange.fr
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MeSH Terms
Descriptor/Qualifier:
Aged
Catheterization / adverse effects,  methods*
Female
Humans
Internationality
Lower Extremity / physiology,  surgery*
Male
Middle Aged
Orthopedic Procedures / adverse effects,  methods*
Peripheral Nerves* / physiology
Polysaccharides / administration & dosage*,  adverse effects
Postoperative Complications / etiology,  prevention & control
Prospective Studies
Thrombolytic Therapy / adverse effects,  methods*
Time Factors
Venous Thrombosis / etiology,  prevention & control
Chemical
Reg. No./Substance:
0/Polysaccharides; 0/fondaparinux
Comments/Corrections
Comment In:
Anesth Analg. 2009 Feb;108(2):670-1; author reply 671-2   [PMID:  19151310 ]

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


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