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Semin Thromb Hemost 2000; 26(6): 657-668
DOI: 10.1055/s-2000-13222
Copyright © 2000 by Thieme Medical Publishers, Inc., 333 Seventh Avenue, New York, NY 10001, USA. Tel.: +1(212) 584-4662

Strategies for the Safe and Effective Exclusion and Diagnosis of Deep Vein Thrombosis by the Sequential Use of Clinical Score, D-Dimer Testing, and Compression Ultrasonography

Jan Jacques Michiels1 , Geneviéve Freyburger2 , Fedde Van Der Graaf3 , Mirian Janssen4 , Wija Oortwijn5 , Edwin J. R. Van Beek6
  • 1Clinical Hemostasis and Thrombosis, Department of Hematology, University Hospital Antwerp and the Goodheart Institute Center for Hemostasis, Thrombosis, and Vascular Pathology, Rotterdam, The Netherlands
  • 2Laboratoire d'Hématologie, Hôpital Pellegrin, Bordeaux, France
  • 3Clinical Laboratories, Sint Joseph Hospital Veldhoven, The Netherlands
  • 4Department of Internal Medicine, Canisius-Wilhelmina Hospital Nijmegen, The Netherlands
  • 5TNO, Prevention and Health, Leiden, The Netherlands
  • 6Division of Clinical Sciences, Academic Radiology, Royal Hallamshire Hospital Sheffield, United Kingdom
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Publication History

Publication Date:
31 December 2000 (online)

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ABSTRACT

Patients with suspected deep vein thrombosis (DVT) are subjected to leg vein compression ultrasonography (CUS) that confirms DVT in only 20 to 30% of patients. A positive CUS is consistent with DVT irrespective of clinical score. The sequential use of a simple clinical score assessment, a rapid sensitive enzyme-linked immunosorbent assay (ELISA) D-dimer test and CUS to safely exclude DVT is promising. The clinical score is a validated clinical model of complaints, signs, and symptoms, on the basis of which a pretest clinical probability for DVT can be estimated as low, moderate, and high. The safe exclusion of DVT by a rapid sensitive D-dimer test in combination with clinical score or CUS necessitates a negative predictive value of more than 99%. The negative predictive value for DVT is determined by the sensitivity of the rapid ELISA D-dimer test and the prevalence of DVT in subgroups of outpatients with suspected DVT. The prevalence of DVT in outpatients with a low, moderate, and high clinical score varies widely from 3 to 10%, 15 to 30% and more than 70%, respectively. A negative rapid ELISA D-dimer and a low clinical score (prevalence DVT 3 to 5%) will have a very high negative predictive value of more than 99.5% to exclude DVT without the need of CUS testing. A negative ELISA D-dimer test and a first-negative CUS safely exclude DVT in patients with a moderate clinical score with a negative predictive value of more than 99.5%, therefore obviating the need to repeat CUS. The use of a rapid ELISA D-dimer testing in patients with a high clinical score is not recommended. A negative CUS, a low clinical score, and a positive ELISA D-dimer, even less than 1000 ng/mL exclude DVT with a negative predictive value of more than 99%. Patients with a negative CUS, but a positive ELISA D-dimer, and a moderate or high clinical score have a probability of DVT of 3 to 5% and 20 to 30%, respectively, and are thus candidates for repeated CUS testing. The proposed sequential use of the clinical score assessment, a rapid ELISA D-dimer test, and CUS will be the most cost-effective diagnostic strategy for DVT because of a significant reduction of CUS examinations and gain of time for the patient and physician in charge.

KEYWORD

Deep vein thrombosis - ELISA D-dimer assay - compression ultrasonography - clinical score - diagnostic management - cost-effectiveness

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