Validation of the age‐adjusted D‐dimer in an ambulatory deep vein thrombosis diagnostic service: beware of superficial thrombophlebitis

SummaryThis study was performed to determine the accuracy of D-Dimer fibrin derivatives, thrombin-antithrombin III (TAT) complexes and prothrombin fragments 1 + 2 (F 1 + 2) determinations for the diagnosis of deep vein thrombosis (DVT). One hundred and sixteen consecutive patients referred to the angiology unit of our hospital for a clinically suspected DVT were investigated. They were submitted to mercury strain gauge plethysmography and to ultrasonic duplex scanning examination; in cases of inconclusive results or of proximal DVT (n = 35), an ascending phlebography was performed. After these investigations were completed, the diagnosis of DVT was confirmed in 34 and excluded in 82. One half of the patients were already under anticoagulant therapy at the time of investigation. The 3 biological markers were assayed using commercially available ELISA techniques and the D-Dimer was also assayed with a fast latex method. The normal distribution of these markers was established in 40 healthy blood donors. The most accurate assay for the diagnosis of DVT was the D-Dimer ELISA which had both a high sensitivity (94%) and a high negative predictive value (95%). The D-Dirner latex, TAT complexes and F 1 + 2 were far less sensitive and provided negative predictive values which ranged between 78 and 85%. In spite of positive and significant correlations between the levels of ihe 3 markers, their association did not improve their overall accuracy for detecting D\/L Therefore, with the exception of the D-Dimer ELISA, these markers were of little value for the diagnosis of DVT in this specific population.

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Evaluation of a New Rapid Quantitative D-dimer Assay in Patients with Clinically Suspected Deep Vein Thrombosis

Thrombosis and Haemostasis ◽

10.1055/s-0038-1650288 ◽

1996 ◽

Vol 75 (03) ◽

pp. 412-416 ◽

Cited By ~ 70

Author(s):

Armando D’Angelo ◽

Gabriella D’Alessandro ◽

Loredana Tomassini ◽

Jean Louis Pittet ◽

G Dupuy ◽

...

Keyword(s):

Deep Vein Thrombosis ◽

Predictive Value ◽

Cost Savings ◽

Pretest Probability ◽

First Episode ◽

Consecutive Series ◽

Vein Thrombosis ◽

Baseline Testing ◽

Deep Vein ◽

D Dimer

SummaryThe sensitivity and specificity for deep vein thrombosis (DVT) of a new rapid, quantitative and precise (total imprecision < 10%) D-dimer assay suitable for individual measurements (VIDAS D-DIMER, bio-Merieux, France) were evaluated in a consecutive series of 103 in- and out-patients submitted to serial compression ultrasonography (C-US) for the clinical suspicion of DVT (n = 66) or of DVT recurrence (n = 37) and symptoms lasting from 1 to 15 days. DVT was found in 22 patients at baseline testing and no patient with an initially negative C-US developed vein incompressibility at follow up. The time elapsed from the onset of symptoms was negatively associated with D-dimer levels both in patients with and in those without DVT. In the entire series of patients, the sensitivity of a positive D-dimer test (≥1.0 Μg/ml) for the presence of DVT was 96% (21/22 patients, 95% confidence interval 75-100%) with a specificity of 75% (64-84%), a negative predictive value of 98% (90-100%), a positive predictive value of 51% (35-67%), and an overall accuracy of 80% (70-87%). A normal D-dimer value (0.22 Μg/ml) was observed in one patient with DVT and symptoms lasting from 15 days. The approach of withholding C-US testing in patients with symptoms lasting from less than 11 days and D-dimer levels below the cut-off value was compared to serial C-US testing alone in a cost-effectiveness analysis subdividing the 66 patients with a first episode according to their clinical pretest probability of DVT. Thrombosis was detected in 6.7% of the patients in the low probability group (n = 15), 16.7% of the patients in the moderate probability group (n = 24), 51.9% of the patients in the high probability group (n = 27) and 8.1% of patients with suspected DVT recurrence. Calculated cost-savings for each DVT diagnosed ranged from 5% in the high pretest probability group to 55% in the low pretest probability group and to 77% in patients with suspected DVT recurrence.The safety of avoiding C-US testing in symptomatic patients with a negative D-dimer test should be evaluated in clinical management studies.

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D-Dimer Test and Diagnosis of Deep Vein Thrombosis: A Comparative Study of 7 Assays

Thrombosis and Haemostasis ◽

10.1055/s-0038-1650615 ◽

1996 ◽

Vol 76 (04) ◽

pp. 518-522 ◽

Cited By ~ 44

Author(s):

A Elias ◽

I Aptel ◽

B Huc ◽

J J Chale ◽

F Nguyen ◽

...

Keyword(s):

Deep Vein Thrombosis ◽

Negative Predictive Value ◽

Predictive Value ◽

Latex Agglutination ◽

Lower Limbs ◽

First Episode ◽

Lower Sensitivity ◽

Vein Thrombosis ◽

Deep Vein ◽

D Dimer

SummaryThe current D-Dimer ELISA methods provide high sensitivity and negative predictive value for the diagnosis of deep vein thrombosis but these methods are not suitable for emergency or for individual determination. We have evaluated the performance of 3 newly available fast D-Dimer assays (Vidas D-Di, BioMerieux; Instant IA D-Di, Stago; Nycocard D-Dimer, Nycomed) in comparison with 3 classic ELISA methods (Stago, Organon, Behring) and a Latex agglutination technique (Stago). One-hundred-and-seventy-one patients suspected of presenting a first episode of deep vein thrombosis were investigated. A deep vein thrombosis was detected in 75 patients (43.8%) by ultrasonic duplex scanning of the lower limbs; in 11 of them the thrombi were distal and very limited in size (<2 cm). We compared the performance of the tests by calculating their sensitivity, specificity, positive and negative predictive value for different cut-off levels and by calculating the area under ROC curves. The concordance of the different methods was evaluated by calculating the kappa coefficient. The performances of the 3 classic ELISA and of the Vidas D-Di were comparable and kappa coefficients indicated a good concordance between the results provided by these assays. Their sensitivity slightly declined for detection of the very small thrombi. Instant IA D-Di had a non-significantly lower sensitivity and negative predictive value than the 4 previous assays; however its performance was excellent for out-patients. As expected, the Latex assay had too low a sensitivity and negative predictive value to be recommended. In our hands, Nycocard D-Dimer also exhibited low sensitivity and negative predictive value, which were significantly improved when the plasma samples were tested by the manufacturer. Thus significant progress has been made, allowing clinical studies to be planned to compare the safety and cost-effectiveness of D-Dimer strategy to those of the conventional methods for the diagnosis of venous thrombosis.

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Rapid Quantitative D-dimer Assay and Clinical Evaluation for the Diagnosis of Clinically Suspected Deep Vein Thrombosis

Thrombosis and Haemostasis ◽

10.1055/s-0038-1656013 ◽

1997 ◽

Vol 77 (03) ◽

pp. 602-603 ◽

Cited By ~ 12

Author(s):

J Y Borg ◽

H Lévesque ◽

N Cailleux ◽

C Franc ◽

M F Hellot ◽

...

Keyword(s):

Deep Vein Thrombosis ◽

Clinical Evaluation ◽

Vein Thrombosis ◽

Deep Vein ◽

D Dimer

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Performance of age-adjusted D-dimer values for predicting DVT before the knee and hip arthroplasty

Journal of Orthopaedic Surgery and Research ◽

10.1186/s13018-020-02172-w ◽

2021 ◽

Vol 16 (1) ◽

Author(s):

Jian Xiang Wu ◽

Jiang Hui Qing ◽

Yao Yao ◽

Dong Yang Chen ◽

Qing Jiang

Keyword(s):

Deep Vein Thrombosis ◽

Odds Ratio ◽

Joint Arthroplasty ◽

Receiver Operating Curve ◽

Multiple Logistic Regression ◽

Vein Thrombosis ◽

Specificity And Sensitivity ◽

Knee And Hip Arthroplasty ◽

Deep Vein ◽

D Dimer

Abstract Purpose To compare the specificity and sensitivity of preoperative D-dimer and age-adjusted D-dimer value for predicting the incidence of the DVT preoperatively in total joint arthroplasty (TJA) patients. Methods We enrolled 406 patients finally above 50 years old. Everyone had done ultrasonography bedside, and D-dimer concentrations were collected before surgery. The D-dimer and age-adjusted D-dimer cut-off was calculated by multiple logistic regression and receiver operating curve (ROC) analyses. Results A total of 39 patients had found asymptomatic deep vein thrombosis (DVT) by ultrasonography. The age (odds ratio [OR] 1.067; p = 0.003) and D-dimer (OR 1.331; p = 0.025) were related to the existence of DVT. For conventional D-dimer and age-adjusted D-dimer value, the area under the curves (AUCs) were 0.685 (0.499–0.696) and 0.795 (0.611–0.881), respectively. Conclusion Compared to traditional D-dimer, age-adjusted D-dimer showed better performance in screening DVT, which was useful clinically.

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D-dimer Driven Deep Vein Thrombosis Prophylaxis Strategy for Hospitalized Patients with COVID-19

Thrombosis Research ◽

10.1016/j.thromres.2021.03.031 ◽

2021 ◽

Author(s):

Kristin Stawiarski ◽

Ariane Loutoo ◽

Leah Velardi ◽

Stuart Zarich

Keyword(s):

Deep Vein Thrombosis ◽

Hospitalized Patients ◽

Thrombosis Prophylaxis ◽

Vein Thrombosis ◽

Deep Vein Thrombosis Prophylaxis ◽

Deep Vein ◽

D Dimer ◽

Prophylaxis Strategy

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Study on the Risk Factors of Preoperative Deep Vein Thrombosis (DVT) in Patients With Lower Extremity Fracture

Clinical and Applied Thrombosis/Hemostasis ◽

10.1177/10760296211002900 ◽

2021 ◽

Vol 27 ◽

pp. 107602962110029

Author(s):

Wenjie Chang ◽

Bin Wang ◽

Qiwei Li ◽

Yongkui Zhang ◽

Wenpeng Xie

Keyword(s):

Risk Factors ◽

Deep Vein Thrombosis ◽

Lower Extremity ◽

Color Doppler ◽

Fracture Site ◽

Vein Thrombosis ◽

Lower Extremity Fracture ◽

Extremity Fracture ◽

Deep Vein ◽

D Dimer

Objective: The objective of this work is to discuss and analyze the related factors of lower extremity fracture complicated by preoperative deep vein thrombosis (DVT). Methods: A total of 11,891 patients with closed fractures of lower extremities were selected. By analyzing each patient’s gender, age, presence or absence of diabetes and hypertension, preoperative plasma D-dimer level, and color Doppler ultrasound of the lower extremity vein, the pertinent factors of the patients with lower extremity fractures complicated by preoperative DVT were analyzed. Results: A total of 578 with preoperative DVT were detected, displaying a total incidence of 4.86%. All patients were categorized into either the DVT group or non-DVT group. The results demonstrate that there were statistically significant differences between the 2 groups in age, the presence of diabetes and hypertension, the fracture site, and the preoperative plasma D-dimer level ( P < 0.05). Logistic multivariate analysis revealed that age, the presence of diabetes, and the preoperative plasma D-dimer level of patients were independent risk factors for lower extremity fracture complicated by DVT. Conclusion: Age, the presence of diabetes, the fracture site, and increased D-dimer levels were found to be potential risk factors and indicators for preoperative DVT in patients with lower extremity fractures. In addition, the preoperative plasma D-dimer level has certain guiding significance for the prediction of venous thrombosis after lower extremity fracture, which is conducive to the early prediction and diagnosis of DVT, but it often must be followed with good clinic acumen and examinations.

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Diagnostic Accuracy of a New d-Dimer Assay (Sclavo Auto d-Dimer) for Exclusion of Deep Vein Thrombosis in Symptomatic Outpatients

Clinical and Applied Thrombosis/Hemostasis ◽

10.1177/1076029616649436 ◽

2016 ◽

Vol 23 (3) ◽

pp. 221-228 ◽

Cited By ~ 1

Author(s):

Cristina Legnani ◽

Michela Cini ◽

Mirella Frascaro ◽

Giuseppina Rodorigo ◽

Michelangelo Sartori ◽

...

Keyword(s):

Deep Vein Thrombosis ◽

Imaging Techniques ◽

False Negative ◽

High Specificity ◽

Predictive Values ◽

Cutoff Value ◽

Vein Thrombosis ◽

Number Of Patients ◽

Deep Vein ◽

D Dimer

In patients presenting non-high clinical pretest probability (PTP), a negative d-dimer can exclude venous thromboembolism without imaging tests. However, each d-dimer assay should be validated in prospective studies. We evaluated an automated d-dimer immunoassay using the Sclavo Auto d-dimer (Sclavo Diagnostics Int, Sovicille, Italy) provided by Dasit Diagnostica (Cornaredo, Milan, Italy). Three hundred two consecutive outpatients suspected of leg deep vein thrombosis (DVT) with non-high PTP were included. The Sclavo Auto d-dimer assay was evaluated on 2 analyzers (Sysmex CA-7000 and Sysmex CS-2100; Sysmex Corporation, Kobe, Japan, provided by Dasit). The cutoff value (200 ng/mL) was established a priori. Prevalence of DVT was 11.9%. Since no false-negative patients were detected, the sensitivity and negative predictive values (NPVs) were 100% (sensitivity = CA-7000: 100% [95% confidence interval, CI: 93.3-100], CS-2100: 100% [95% CI: 93.3-100]; NPV = CA-7000: 100% [95% CI: 97.9-100], CS-2100: 100% [95% CI: 98.0-100]). Specificity was 65.4% (95% CI: 59.4-71.1) and 69.2% (95% CI: 63.3-74.7) for CA-7000 and CS-2100, respectively. Specificity increased when a higher cutoff value (234 ng/mL) was used for patients aged ≥60 years without compromising the safety. Assay reproducibility was satisfactory at concentrations near the cutoff value (total coefficient of variations <10%). In conclusion, the Sclavo Auto d-dimer assay was accurate when used for DVT diagnostic workup in outpatients with non-high PTP. Based on its high sensitivity and NPV, it can be used as a stand-alone test in outpatients with non-high PTP. Given its high specificity, the number of patients in whom further imaging techniques can be avoided increased, improving the yield of the test.

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