Exclusion of venous thromboembolism: Evaluation of D-Dimer PLUS for the quantitative determination of D-dimer

HagaZiekenhuis van Den Haag, 's-Gravenhage, South Holland, Netherlands
Thrombosis Research (Impact Factor: 2.45). 02/2005; 115(5):381-6. DOI: 10.1016/j.thromres.2004.09.005
Source: PubMed


The objective of this study was to evaluate if D-Dimer PLUS (Dade Behring, USA), a rapid fully automated assay, could be used as an initial screening test in the diagnosis of venous thromboembolism (VTE). Samples from 274 consecutive symptomatic patients with suspected pulmonary embolism (n=229; 79% outpatients, 21% inpatients), deep venous thrombosis (n=37; 84% outpatients, 16% inpatients) or suspected for both complications (n=8) were tested with this D-dimer assay with a Sysmex CA-1500 Coagulation Analyzer. Clinical probability for pulmonary embolism (PE) or deep venous thrombosis (DVT) was staged according to a pretest risk score proposed by Wells. Final diagnosis of PE and/or DVT was established by spiral-computed tomography of the pulmonary arteries or compression ultrasonography, respectively. PE was diagnosed in 13.5% of the patients, whereas DVT was confirmed in 17.7% of the patients. The optimal cut-off value for exclusion of venous thromboembolism was 130 mug/l, and sensitivity, specificity and negative predictive value (NPV) were 95.0% (95% CI: 92.4-97.6), 30.4% (95% CI: 25.0-35.8) and 97.2% (95% CI: 95.2-99.2), respectively. In fact, two patient with PE were missed using D-Dimer PLUS; both cases were outpatients. In conclusion, this assay appears to be safe when implemented in an algorithm based on clinical assessment, D-dimer concentration, and radiological diagnostic techniques to stratify the risk for PE or DVT. However, higher sensitivities and negative predictive values were claimed in the scarce published reports for the D-Dimer PLUS assay than found in this study.

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    • "D-dimer is a degradation product of cross-linked fibrin from blood clots and is commonly employed as a highly sensitive (>95%) test for acute VTE that is very accurate for excluding this condition (its negative predictive value is 97%) [5], [6]. Measurement of D-dimer is particularly useful to exclude VTE in outpatients [2]. "
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    ABSTRACT: To develop a convenient screening method that can predict perioperative venous thromboembolism (VTE) and identify patients at risk of fatal perioperative pulmonary embolism (PE). Patients hospitalized for gynecological abdominal surgery (n = 183) underwent hematology tests and multidetector computed tomography (MDCT) to detect VTE. All statistical analyses were carried out using the SPSS software program (PASWV19.0J). THE FOLLOWING RISK FACTORS FOR VTE WERE IDENTIFIED BY UNIVARIATE ANALYSIS: plasmin-alpha2-plasmin inhibitor complex (PIC), thrombin-antithrombin III complex (TAT), and prolonged immobility (all p<0.001); age, neoadjuvant chemotherapy (NAC), malignancy, hypertension, past history of VTE, and hormone therapy (all p<0.01); and hemoglobin, transverse tumor diameter, ovarian disease, and menopause (all p<0.05). Multivariate analysis using these factors revealed that PIC, age, and transverse tumor diameter were significant independent determinants of the risk of VTE. We then calculated the incidence rate of perioperative VTE using PIC and transverse tumor diameter in patient groups stratified by age. In patients aged≦40 years, PIC ≧1.3 µg/mL and a transverse tumor diameter ≧10 cm identified the high-risk group for VTE with an accuracy of 93.6%. For patients in their 50 s, PIC ≧1.3 µg/mL identified a high risk of VTE with an accuracy of 78.2%. In patients aged ≧60 years, a transverse tumor diameter ≧15 cm (irrespective of PIC) or PIC ≧1.3 µg/mL identified the high-risk group with an accuracy of 82.4%. We propose new screening criteria for VTE risk that are based on PIC, transverse tumor diameter, and age. Our findings suggest the usefulness of these criteria for predicting the risk of perioperative VTE and for identifying patients with a high risk of fatal perioperative PE.
    Full-text · Article · Feb 2014 · PLoS ONE
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    • "With the current rapid tests, both the sensitivity and the negative predictive value are usually high (mostly > 95%) [7-10]. Wermeer et al., by comparing D-dimer PLUS in combination with preclinical scores, have provided a useful tool for clinicians to safely exclude PE or DVT [11]. "
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    ABSTRACT: Pulmonary embolism (PE) is diagnosed with increasing frequency nowadays due to advances in the diagnostic methods and the increased awareness of the disease. There is a tendency to use non invasive diagnostic methods for all diseases. D-dimer is a fibrin degradation product. We aimed to detect the relationship between disease severity and the D-dimer levels measured with two different methods. We compared D-dimer levels in cases of massive vs. non-massive PE. A total of 89 patients who were diagnosed between 2006 and 2008 were included in the study. Group 1 included patients whose D-dimer levels were measured with the immunoturbidimetric polyclonal antibody method (D-dimerPLUS®), while Group 2 patients made use of the immunoturbidimetric monoclonal antibody method (InnovanceD-DIMER®). In each group, the D-dimer levels of those with massive and non-massive PE were compared, using the Mann Whitney U test. The mean age of Group 1 (25 F/26 M) was 56.0 ± 17.9 years, and that of Group 2 (22 F/16 M) was 52.9 ± 17.9 years. There was no statistical difference in gender and mean age between the two groups (p > 0.05). In Group 1, the mean D-dimer level of massive cases (n = 7) was 1444.9 ± 657.9 μg/L and that of nonmassive PE (n = 34) was 1304.7 ± 350.5 μg/L (p > 0.05). In Group 2, the mean D-dimer level of massive cases (n = 6) was 9.7 ± 2.2 mg/L and that of non-massive PE (n = 32) was 5.9 ± 1.3 mg/L (p < 0.05). The mean D-dimer levels of massive cases as measured with the immunoturbidimetric monoclonal antibody method were significantly higher. Pulmonary embolism patients whose D-dimer levels are higher (especially higher than 6.6 mg/L) should be considered as possibly having massive embolism. Diagnostic procedures and management can be planned according to this finding.
    Preview · Article · Jun 2010 · Multidisciplinary respiratory medicine
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    • "The diagnosis is often a challenge because the clinical signs and symptoms of VTE are difficult to interpret [1] [2], and diagnostic tests are often necessary for diagnosis. Of all patients presenting with symptoms suggestive of DVT or PE, only 15–25% actually have the disease [3] [4] [5] [6] [7]. Therefore, a simple, reproducible diagnostic tool is needed to identify patients with a low probability of having the disease in order to obviate the need for further diagnostic tests. "
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    ABSTRACT: Patients presenting with symptoms suggestive of venous thromboembolism (VTE), i.e., deep vein thrombosis (DVT) and pulmonary embolism (PE), are common at the emergency departments. However, of those, only 15-25% actually have the disease. The aims of this study were to determine (1) if low pre-test probability (PTP) using the Wells score, together with a normal D-dimer, safely excludes VTE in outpatients and (2) if a follow-up D-dimer adds extra information. Patients (n=151, 68% women) with suspected VTE, a PTP below 1.5, and a D-dimer test (TinaQuant) below 0.5 mg/L were included in the study and underwent no further diagnostic investigations. Patients (n=177, 54% women) with D-dimer levels of 0.5 mg/L or higher or a PTP of 1.5 or higher were excluded. A follow-up D-dimer test was conducted 3-7 days after the initial hospital visit and further diagnostic investigations were made if test results were abnormal. Patients were studied for 3 months. A follow-up D-dimer test was conducted in 101/151 cases (67%), 13/101 of which revealed elevated D-dimer levels. None of these 13 patients had persistent symptoms or was diagnosed with VTE. All 151 patients were contacted after 3 months; none of them had clinical signs of VTE. Of the 177 patients excluded, 45 (25%) were diagnosed with VTE. Of the 176/328 (151+177) patients with normal D-dimer levels, only 1 had VTE (<0.01%). A normal PTP using the Wells score and a normal D-dimer safely excludes VTE at the emergency department. A follow-up D-dimer test adds no further information.
    Full-text · Article · Jul 2008 · European Journal of Internal Medicine
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