Document Detail


Prediction and prevention of thromboembolic events with enoxaparin in cancer patients with elevated tissue factor-bearing microparticles: a randomized-controlled phase II trial (the Microtec study).
MedLine Citation:
PMID:  23240761     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
Elevated levels of circulating tissue factor-bearing microparticles (TFMP) have been associated with an increased risk of developing venous thromboembolism (VTE) in cancer patients. We performed a randomized phase II study to evaluate the cumulative incidence of VTE in advanced cancer patients with lower levels of TFMP not receiving thromboprophylaxis and those with higher levels of circulating TFMP randomized to enoxaparin or observation. The cumulative incidence of VTE at 2 months in the higher TFMP group randomized to enoxaparin (N = 23) was 5·6% while the higher TFMP group observation arm (N = 11) was 27·3% (Gray test P = 0·06). The cumulative incidence of VTE in the low TFMP was 7·2% (N = 32). No major haemorrhages were observed in the enoxaparin arm. The median survival for patients with higher levels of TFMP followed by observation was 11·8 months compared with 17·8 months on enoxaparin (P = 0·58). In a prospective randomized trial, increased numbers of circulating TFMP detected by impedance flow cytometry identified cancer patients with a high incidence of VTE. Enoxaparin demonstrated a clear trend towards reducing the rate of VTE in patients with elevated levels of TFMP, with an overall rate of VTE similar in magnitude to the lower TFMP group.
Authors:
Jeffrey I Zwicker; Howard A Liebman; Kenneth A Bauer; Thomas Caughey; Federico Campigotto; Rachel Rosovsky; Simon Mantha; Craig M Kessler; Jonathan Eneman; Vidya Raghavan; Heinz-Joseph Lenz; Andrea Bullock; Elizabeth Buchbinder; Donna Neuberg; Bruce Furie
Publication Detail:
Type:  Clinical Trial, Phase II; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't     Date:  2012-12-13
Journal Detail:
Title:  British journal of haematology     Volume:  160     ISSN:  1365-2141     ISO Abbreviation:  Br. J. Haematol.     Publication Date:  2013 Feb 
Date Detail:
Created Date:  2013-04-23     Completed Date:  2013-06-17     Revised Date:  2014-02-04    
Medline Journal Info:
Nlm Unique ID:  0372544     Medline TA:  Br J Haematol     Country:  England    
Other Details:
Languages:  eng     Pagination:  530-7     Citation Subset:  IM    
Copyright Information:
© 2012 Blackwell Publishing Ltd.
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MeSH Terms
Descriptor/Qualifier:
Aged
Aged, 80 and over
Anticoagulants / therapeutic use*
Cell-Derived Microparticles / metabolism
Enoxaparin / therapeutic use*
Female
Fibrin Fibrinogen Degradation Products / metabolism
Humans
Male
Middle Aged
Neoplasms / complications*
Survival Analysis
Thromboembolism / prevention & control*
Thromboplastin / metabolism*
Grant Support
ID/Acronym/Agency:
K23 HL084052/HL/NHLBI NIH HHS; K23 HL84052/HL/NHLBI NIH HHS; L30 HL074959/HL/NHLBI NIH HHS; R01 HL095084/HL/NHLBI NIH HHS; UL1 TR000130/TR/NCATS NIH HHS
Chemical
Reg. No./Substance:
0/Anticoagulants; 0/Enoxaparin; 0/Fibrin Fibrinogen Degradation Products; 0/fibrin fragment D; 9035-58-9/Thromboplastin
Comments/Corrections

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


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