Document Detail


Safety and efficacy of intravenous enoxaparin for carotid endarterectomy: a prospective randomized pilot trial.
MedLine Citation:
PMID:  18234466     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
OBJECTIVE: This prospective, randomized, single-center, open-label pilot study evaluated the safety and efficacy in carotid surgery of a single intraoperative bolus of body weight-adjusted enoxaparin compared with unfractionated heparin.
METHODS: Symptomatic and asymptomatic patients with high-grade internal carotid artery stenosis were included. The primary objective was to evaluate perioperative efficacy (incidence of thromboembolic ischemic stroke). The secondary objective was to evaluate safety, including avoidance of hematoma at the site of surgery, gastrointestinal bleeding, rate of blood transfusions, and occurrence of heparin-induced thrombocytopenia.
RESULTS: From July 2005 to June 2006, 338 consecutive patients undergoing carotid endarterectomy were enrolled; of these, 115 patients did not fulfill inclusion criteria, and 63 patients refused to participate. The remaining 160 patients were assigned in a 3:1 randomization to receive enoxaparin (0.5 mg/kg) or unfractionated heparin (5000 IU) intraoperatively as an intravenous bolus (120 and 40 patients, respectively). The mean patient age was 70.3 years (range, 43.3-94.7 years), and 54 were women. Internal carotid artery stenosis was asymptomatic in 55% and symptomatic in 45%. The difference in baseline characteristics between these groups was not significant. The rate of cerebral embolic events was 0.8% in the enoxaparin group (n = 1) and 2.5% in the unfractionated heparin group (n = 1). The rate of severe bleeding complications was 1.7% in the enoxaparin group (n = 2) and 5% in the unfractionated heparin group (n = 2; P > .05). No case of heparin-induced thrombocytopenia was observed.
CONCLUSION: This pilot study found no difference between enoxaparin and unfractionated heparin during carotid endarterectomy in perioperative bleeding or embolic events. A large multicenter trial seems to be warranted.
Authors:
Afshin Assadian; Paul Knöbl; Wolfgang Hübl; Christian Senekowitsch; Anton Klingler; Norbert Pfaffelmeyer; Georg W Hagmüller
Related Documents :
21044026 - Early postoperative bleeding in polytrauma patients treated with fondaparinux: literatu...
10069766 - Unfractionated heparin and low-molecular-weight heparin for the initial treatment of ac...
22742866 - Skin temperature during cutaneous wound healing in an equine model of cutaneous fibropr...
2645846 - Prevention of deep vein thrombosis in potential neurosurgical patients. a randomized tr...
7571136 - Serial assessment of adnexal masses with transvaginal color doppler sonography.
18986246 - Two-months-off, four-months-on antiretroviral regimen increases the risk of resistance,...
Publication Detail:
Type:  Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2008-01-30
Journal Detail:
Title:  Journal of vascular surgery     Volume:  47     ISSN:  0741-5214     ISO Abbreviation:  J. Vasc. Surg.     Publication Date:  2008 Mar 
Date Detail:
Created Date:  2008-02-25     Completed Date:  2008-04-18     Revised Date:  2012-10-03    
Medline Journal Info:
Nlm Unique ID:  8407742     Medline TA:  J Vasc Surg     Country:  United States    
Other Details:
Languages:  eng     Pagination:  537-42     Citation Subset:  IM    
Affiliation:
Department of General and Vascular Surgery, Wilhelminenspital, Vienna, Austria. afshin_assadian@yahoo.de
Export Citation:
APA/MLA Format     Download EndNote     Download BibTex
MeSH Terms
Descriptor/Qualifier:
Adult
Aged
Aged, 80 and over
Anticoagulants / administration & dosage*,  adverse effects
Blood Loss, Surgical / prevention & control*
Blood Transfusion
Brain Ischemia / complications,  etiology,  prevention & control*
Carotid Artery, Internal / surgery
Carotid Stenosis / drug therapy,  surgery*
Endarterectomy, Carotid / adverse effects*
Enoxaparin / administration & dosage*,  adverse effects
Female
Gastrointestinal Hemorrhage / chemically induced,  prevention & control
Hematoma / chemically induced,  prevention & control
Heparin / administration & dosage*,  adverse effects
Humans
Injections, Intravenous
Male
Middle Aged
Pilot Projects
Prospective Studies
Stroke / complications,  etiology,  prevention & control*
Thrombocytopenia / chemically induced,  prevention & control
Thromboembolism / complications,  etiology,  prevention & control*
Treatment Outcome
Chemical
Reg. No./Substance:
0/Anticoagulants; 0/Enoxaparin; 9005-49-6/Heparin

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


Previous Document:  The prevalence of hypoechoic carotid plaques is greater in peripheral than in coronary artery diseas...
Next Document:  Cryptosporidium from tortoises: Genetic characterisation, phylogeny and zoonotic implications.