Document Detail

Evaluation of D-dimer in the diagnosis of suspected deep-vein thrombosis.
MedLine Citation:
PMID:  14507948     Owner:  NLM     Status:  MEDLINE    
BACKGROUND: Several diagnostic strategies using ultrasound imaging, measurement of D-dimer, and assessment of clinical probability of disease have proved safe in patients with suspected deep-vein thrombosis, but they have not been compared in randomized trials. METHODS: Outpatients presenting with suspected lower-extremity deep-vein thrombosis were potentially eligible. Using a clinical model, physicians evaluated the patients and categorized them as likely or unlikely to have deep-vein thrombosis. The patients were then randomly assigned to undergo ultrasound imaging alone (control group) or to undergo D-dimer testing (D-dimer group) followed by ultrasound imaging unless the D-dimer test was negative and the patient was considered clinically unlikely to have deep-vein thrombosis, in which case ultrasound imaging was not performed. RESULTS: Five hundred thirty patients were randomly assigned to the control group, and 566 to the D-dimer group. The overall prevalence of deep-vein thrombosis or pulmonary embolism was 15.7 percent. Among patients for whom deep-vein thrombosis had been ruled out by the initial diagnostic strategy, there were two confirmed venous thromboembolic events in the D-dimer group (0.4 percent; 95 percent confidence interval, 0.05 to 1.5 percent) and six events in the control group (1.4 percent; 95 percent confidence interval, 0.5 to 2.9 percent; P=0.16) during three months of follow-up. The use of D-dimer testing resulted in a significant reduction in the use of ultrasonography, from a mean of 1.34 tests per patient in the control group to 0.78 in the D-dimer group (P=0.008). Two hundred eighteen patients (39 percent) in the D-dimer group did not require ultrasound imaging. CONCLUSIONS: Deep-vein thrombosis can be ruled out in a patient who is judged clinically unlikely to have deep-vein thrombosis and who has a negative D-dimer test. Ultrasound testing can be safely omitted in such patients.
Philip S Wells; David R Anderson; Marc Rodger; Melissa Forgie; Clive Kearon; Jonathan Dreyer; George Kovacs; Michael Mitchell; Bernard Lewandowski; Michael J Kovacs
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Publication Detail:
Type:  Clinical Trial; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  The New England journal of medicine     Volume:  349     ISSN:  1533-4406     ISO Abbreviation:  N. Engl. J. Med.     Publication Date:  2003 Sep 
Date Detail:
Created Date:  2003-09-25     Completed Date:  2003-09-29     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  0255562     Medline TA:  N Engl J Med     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1227-35     Citation Subset:  AIM; IM    
Copyright Information:
Copyright 2003 Massachusetts Medical Society
Department of Medicine, Ottawa Hospital, University of Ottawa, Ottawa, Ont, Canada.
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MeSH Terms
Agglutination Tests
Fibrin Fibrinogen Degradation Products / analysis*
Middle Aged
Predictive Value of Tests
Pulmonary Embolism / diagnosis,  epidemiology
Venous Thrombosis / diagnosis*,  epidemiology,  ultrasonography
Reg. No./Substance:
0/Fibrin Fibrinogen Degradation Products; 0/fibrin fragment D
Comment In:
N Engl J Med. 2004 Jan 8;350(2):192-4; author reply 192-4   [PMID:  14714283 ]
N Engl J Med. 2003 Sep 25;349(13):1203-4   [PMID:  14507947 ]
N Engl J Med. 2004 Jan 8;350(2):192-4; author reply 192-4   [PMID:  14714282 ]
N Engl J Med. 2004 Jan 8;350(2):192-4; author reply 192-4   [PMID:  14711923 ]
N Engl J Med. 2004 Jan 8;350(2):192-4; author reply 192-4   [PMID:  14714281 ]
ACP J Club. 2004 May-Jun;140(3):67   [PMID:  15122830 ]

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