Performance of five D-dimer assays for the exclusion of symptomatic distal leg vein thrombosis

2012 ◽  
Vol 107 (02) ◽  
pp. 369-378 ◽  
Author(s):  
Jan Schwonberg ◽  
Carola Hecking ◽  
Marc Schindewolf ◽  
Dimitrios Zgouras ◽  
Susanne Lehmeyer ◽  
...  
Keyword(s):  
High Sensitivity ◽  
Diagnostic Value ◽  
Vein Thrombosis ◽  
Clinical Probability ◽  
Wells Score ◽  
Deep Vein ◽  
Test Result ◽  
D Dimer ◽  
Rule Out ◽  
Compression Ultrasonography

SummaryThe diagnostic value of D-dimer (DD) in the exclusion of proximal deep-vein thrombosis (DVT) is well-established but is less well-known in the exclusion of distal (infrapopliteal) DVT. Therefore, we evaluated the diagnostic abilities of five DD assays (Vidas-DD, Liatest-DD, HemosIL-DD, HemosIL-DDHS, Innovance-DD) for excluding symptomatic proximal and distal leg DVT. A total of 243 outpatients whose symptoms were suggestive of DVT received complete compression ultrasonography (cCUS) of the symptomatic leg(s). The clinical probability of DVT (PTP) was assessed by Wells score. Thirty-eight proximal and 31 distal DVTs (17 tibial/fibular DVTs, 14 muscle DVTs) were diagnosed by cCUS. Although all assays showed high sensitivity for proximal DVT (range 97–100%), the sensitivity was poor for distal DVT (range 78–93%). None of the assays were individually able to rule out all DVTs as a stand-alone test (negative predictive value [NPV] 91–96%). However, a negative DD test result combined with a low PTP exhibited a NPV of 100% for all DVTs (including proximal, tibial/fibular, and muscle DVTs) with the HemosIL-DDHS and Innovance-DD. All proximal and tibial/fibular DVTs, but not all muscle DVTs, could be ruled out with this strategy using the Liatest-DD and Vidas-DD. The HemosIL-DD could not exclude distal leg DVT, even in combination with a low PTP. The combination of a negative DD with a low PTP showed a specificity of 32–35% for all DVTs. In conclusion, our study shows that when used in conjunction with a low PTP some DD assays are useful tools for the exclusion of distal leg DVT.

D-Dimers, Thrombin Antithrombin III Complexes and Prothrombin Fragments 1 + 2: Diagnostic value in Clinically Suspected Deep Vein Thrombosis

1991 ◽  
Vol 65 (01) ◽  
pp. 028-032 ◽  
Author(s):  
B Boneu ◽  
G Bes ◽  
H Pelzer ◽  
P Sié ◽  
H Boccalon
Keyword(s):  
Deep Vein Thrombosis ◽  
Antithrombin Iii ◽  
High Sensitivity ◽  
Diagnostic Value ◽  
Predictive Values ◽  
Vein Thrombosis ◽  
High Negative Predictive Value ◽  
Deep Vein ◽  
D Dimer ◽  
Mercury Strain Gauge

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.

scholarly journals Safety of a strategy combining D-dimer testing and whole-leg ultrasonography to rule out deep vein thrombosis

2020 ◽  
Vol 4 (20) ◽  
pp. 5002-5010
Author(s):  
Synne G. Fronas ◽  
Camilla T. Jørgensen ◽  
Anders E. A. Dahm ◽  
Hilde S. Wik ◽  
Jostein Gleditsch ◽  
...  
Keyword(s):  
Deep Vein Thrombosis ◽  
Pretest Probability ◽  
Vein Thrombosis ◽  
Venous Thromboembolic ◽  
Deep Vein ◽  
D Dimer ◽  
Rule Out ◽  
Compression Ultrasonography ◽  
High Pretest Probability

Abstract Guidelines for the diagnostic workup of deep vein thrombosis (DVT) recommend assessing the clinical pretest probability before proceeding to D-dimer testing and/or compression ultrasonography (CUS) if the patient has high pretest probability or positive D-dimer. Referring only patients with positive D-dimer for whole-leg CUS irrespective of pretest probability may simplify the workup of DVT. In this prospective management outcome study, we assessed the safety of such a strategy. We included consecutive outpatients referred to the Emergency Department at Østfold Hospital, Norway, with suspected DVT between February 2015 and November 2018. STA-Liatest D-Di Plus D-dimer was analyzed for all patients, and only patients with levels ≥0.5 µg/mL were referred for CUS. All patients with negative D-dimer or negative CUS were followed for 3 months to assess the venous thromboembolic rate. One thousand three hundred ninety-seven patients were included. Median age was 64 years (interquartile range, 52-73 years), and 770 patients (55%) were female. D-dimer was negative in 415 patients (29.7%) and positive in 982 patients (70.3%). DVT was diagnosed in 277 patients (19.8%). Six patients in whom DVT was ruled out at baseline were diagnosed with DVT within 3 months of follow-up for a thromboembolic rate of 0.5% (95% confidence interval, 0.2-1.2). A simple diagnostic approach with initial stand-alone D-dimer followed by a single whole-leg CUS in patients with positive D-dimer safely ruled out DVT. We consider this strategy to be a valuable alternative to the conventional workup of DVT in outpatients. This trial was registered at www.clinicaltrials.gov as #NCT02486445.

scholarly journals P001: Age-adjusted D-dimer and two-site compression point of care ultrasonography to rule out acute deep vein thrombosis - a pilot study

CJEM ◽  
2018 ◽  
Vol 20 (S1) ◽  
pp. S57-S57
Author(s):  
K. Alqaydi ◽  
J. Turner ◽  
L. Robichaud ◽  
D. Hamad ◽  
X. Xue ◽  
...  
Keyword(s):  
Deep Vein Thrombosis ◽  
Point Of Care ◽  
Screening Tools ◽  
Duplex Scan ◽  
Vein Thrombosis ◽  
Wells Score ◽  
Deep Vein ◽  
D Dimer ◽  
Rule Out

Introduction: Deep vein thrombosis (DVT) can lead to significant morbidity and mortality if not diagnosed and treated promptly. Currently, few methods aside from venous duplex scanning can rule out DVT in patients presenting to the Emergency Department (ED). Current screening tools, including the use of the subjective Wells score, frequently leads to unnecessary investigations and anticoagulation. In this study, we sought to determine whether two-site compression point-of-care ultrasound (POCUS) combined with a negative age-adjusted D-dimer test can accurately rule out DVT in ED patients irrespective of the modified Wells score. Methods: This is a single-center, prospective observational study in the ED of the Jewish General Hospital in Montreal. We are recruiting a convenience sample of patients presenting to the ED with symptoms suggestive of DVT. All enrolled patients are risk-stratified using the modified Wells criteria for DVT, then undergo two-site compression POCUS, and testing for age-adjusted D-dimer. Patients with DVT unlikely according to modified Wells score, negative POCUS and negative age-adjusted D-dimer are discharged home and receive a three-month phone follow-up. Patients with DVT likely according to modified Wells score, a positive POCUS or a positive age-adjusted D-dimer, will undergo a venous duplex scan. A true negative DVT is defined as either a negative venous duplex scan or a negative follow-up phone questionnaire for patients who were sent home without a venous duplex scan. Results: Of the 42 patients recruited thus far, the mean age is 56 years old and 42.8% are male. Twelve (28.6%) patients had DVT unlikely as per modified Wells score, negative POCUS and negative age-adjusted D-dimer and were discharged home. None of these patients developed a DVT on three-month follow-up. Thirty patients (71.4%) had either a DVT likely as per modified Wells score, a positive POCUS or a positive age-adjusted D-dimer and underwent a venous duplex scan. Of those, six patients had a confirmed DVT (3 proximal & 3 distal). POCUS detected all proximal DVTs, while combined POCUS and age-adjusted D-dimer detected all proximal and distal DVTs. None of the patients with a negative POCUS and age-adjusted D-dimer were found to have a DVT. Conclusion: Two-site compression POCUS combined with a negative age-adjusted D-dimer test appears to accurately rule out DVT in ED patients without the need for follow-up duplex venous scan. Using this approach would alleviate the need to calculate the Wells score, and also reduce the need for radiology-performed duplex venous scan for many patients.

scholarly journals LO55: Comparison of the age-adjusted D-dimer, clinical probability-adjusted D-dimer, and Wells rule with D-dimer for diagnosing deep vein thrombosis in the emergency department.

CJEM ◽  
2020 ◽  
Vol 22 (S1) ◽  
pp. S27-S27
Author(s):  
S. Sharif ◽  
C. Kearon ◽  
M. Eventov ◽  
P. Sneath ◽  
M. Li ◽  
...  
Keyword(s):  
False Negative ◽  
False Negative Rate ◽  
Duplex Ultrasonography ◽  
Vein Thrombosis ◽  
Clinical Probability ◽  
Negative Rate ◽  
Wells Score ◽  
Wells Rule ◽  
Deep Vein ◽  
D Dimer

Introduction: Diagnosing deep vein thrombosis (DVT) is of critical importance because of its associated morbidity and mortality. Diagnosing DVT can be challenging in the Emergency Department (ED) due to inconsistent adherence to, and utilization of the Wells rule. Both the age-adjusted and clinical probability adjusted D-dimer have been shown to decrease ultrasound (US) utilization rates. We aimed to compare the safety and efficacy of the Wells score with D-dimer to the age-adjusted and clinical probability-adjusted D-dimer in Canadian ED patients tested for DVT. Methods: This was a health records review of ED patients investigated for DVT at two EDs over a two-year period. Inclusion criteria were ED physician ordered duplex ultrasonography or D-dimer for investigation of lower limb DVT. Patients under the age of 18 were excluded. DVT was considered to be present during the ED visit if DVT was diagnosed on duplex ultrasonography and was treated for acute DVT, or if the patient was subsequently diagnosed with pulmonary embolism (PE) or DVT during the next 30 days. Trained researchers extracted anonymized data. The Wells D-dimer, age-adjusted D-dimer, and the clinical probability-adjusted D-dimer rules were applied retrospectively. The rate of duplex ultrasonography imaging and the false negative rate was calculated for each rule. Results: Between April 1st 2013 and March 31st 2015, there were 1,198 patients tested for DVT. Of the low and moderate clinical pretest probability patients (Wells score ≤ 2), only 436 had a D-Dimer test and were eligible for our analysis. The average age of the patients was 59, 56% were female, and 4% had a malignancy. 207/436 patients (47.4%, 95%CI 42.8-52.2%) would have had US imaging for DVT if the age-adjusted D-dimer rule was used. 214/436 patients (49.1%, 95%CI 44.4-53.8%) would have had imaging for DVT if the clinical probability-adjusted D-dimer was used. If the Wells rule was used with the standard D-dimer cutoff of 500, 241/436 patients (55.2%, 95%CI 50.6-59.9%) would have had imaging for DVT. The false-negative rate for the Wells rule was 1.5% (95%CI 0.5-4.4%). The false-negative rate for the age-adjusted D-dimer rule was 1.3% (95%CI 0.4-3.8%). The false-negative rate for the clinical-probability adjusted D-Dimer was 1.8% (95%CI 0.7-4.5%). Conclusion: In comparison with the approach of the Wells score and D-dimer, both the age-adjusted and clinical probability-adjusted D-dimer diagnostic strategies could reduce the proportion of patients who require US imaging.

Age-adjusted D-dimer for the diagnosis of deep vein thrombosis

2017 ◽  
Vol 33 (7) ◽  
pp. 458-463 ◽  
Author(s):  
Efrem Gómez-Jabalera ◽  
Sergio Bellmunt Montoya ◽  
Eva Fuentes-Camps ◽  
José Román Escudero Rodríguez
Keyword(s):  
Deep Vein Thrombosis ◽  
False Negative ◽  
Intermediate Risk ◽  
Vein Thrombosis ◽  
Clinical Probability ◽  
Specificity And Sensitivity ◽  
Wells Score ◽  
Risk Patients ◽  
Deep Vein ◽  
D Dimer

Objective In the diagnosis of deep vein thrombosis, new D-dimer cut-off values were defined by multiplying 10 µg/L × age. The objective of the present study is to define a more specific age-adjusted value, including the pre-test Wells score, without worsening sensitivity. Methods We designed a case–control study in patients attended in the emergency department with clinically suspected deep vein thrombosis. Demographics, Wells score, D-dimer and ultrasound data were collected. In low and intermediate clinical probability cases for deep vein thrombosis, we determined the specificity and sensitivity (false-negative rates) for the following cut-off values of D-dimer: age × 10 µg/L, age × 15 µg/L, age × 20 µg/L, age × 25 µg/L and age × 30 µg/L. The cut-off value with maximum specificity without any false-negative result (sensitivity 100%) was identified. Results We included 138 consecutive patients, 39.9% were men and the mean age was 71.6 years. Deep vein thrombosis was diagnosed in 16.7% of patients and the Wells score was low in 69.6%, intermediate in 21% and high in 9.4% of patients. Applying the conventional cut-off value of 500 µg/L, the specificity was 21.1% with a sensitivity of 100%. Maintaining 100% sensitivity, the highest specificity was reached with a cut-off value for D-dimer equivalent to the age × 25 µg/L in low-risk patients (67.1% specificity) and the age × 10 µg/L (50% specificity) in intermediate-risk patients. Conclusions In patients with low Wells score, the cut-off value can be raised to age × 25 µg/L in order to rule out deep vein thrombosis without jeopardizing safety. In intermediate-risk patients, the D-dimer cut-off value could be raised to age × 10 µg/L as previously suggested.

scholarly journals Sensitivity and specificity of D-dimer tests comparing to the ultrasound examination of deep vein thrombosis

2018 ◽  
Vol 146 (5-6) ◽  
pp. 303-308
Author(s):  
Dragan Markovic ◽  
Dragan Vasic ◽  
Jelena Basic ◽  
Slobodan Tanaskovic ◽  
Slobodan Cvetkovic ◽  
...  
Keyword(s):  
Deep Vein Thrombosis ◽  
Sensitivity And Specificity ◽  
Predictive Values ◽  
Vein Thrombosis ◽  
Wells Score ◽  
Examination Methods ◽  
False Diagnosis ◽  
Deep Vein ◽  
D Dimer ◽  
Compression Ultrasonography

Introduction/Objective. Untreated deep vein thrombosis (DVT) is associated with a high risk of pulmonary embolism (PE), and false diagnosis of DVT results in unnecessary anticoagulant therapy, with a risk of bleeding. Accurate diagnosis of DVT and prompt therapy are essential to reduce the risk of thromboembolic complications. The aim of our study was to evaluate the sensitivity and specificity of three D-dimer tests (DD PLUS, HemosIL, and VIDAS) comparing to compression ultrasonography (CUS) examination. Methods. We observed 350 patients, some with different risk factors. The patients underwent the same protocol (evaluation of the patient?s history, physical examination, and D-dimer testing), and CUS was used as a reference for all the patients. According to Wells score, the patients were divided into groups with low, moderate, and high pretest probability (PTP). Results. Most of the examined patients were with moderate PTP. The CUS showed that there was the highest number of examined patients without DVT. Most of the examined patients with a positive CUS finding had proximal iliac and femoral DVT. VIDAS test was positive in the highest percentage in the group of patients with CUS-documented thrombosis. Conclusion. All three D-dimer tests used in our study had similar sensitivity and specificity. However, VIDAS test had higher levels of positive and negative predictive values comparing to the others. The comparison of three D-dimer tests by an ROC curve showed that VIDAS test has the highest overall statistical accuracy of all three D-dimer tests.

scholarly journals Physician and Patient Beliefs and Preferences in Pulmonary Embolism and Deep Vein Thrombosis Testing in People with Cancer

Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 4265-4265
Author(s):  
Anna Tran ◽  
Kerstin De Wit ◽  
Darshana Seeburruth
Keyword(s):  
Pulmonary Embolism ◽  
Diagnostic Imaging ◽  
Cancer Patients ◽  
Evidence Based ◽  
Vein Thrombosis ◽  
Clinical Probability ◽  
Wells Score ◽  
Low Threshold ◽  
Deep Vein ◽  
D Dimer

Abstract Introduction It is unclear whether evidence-based diagnostic protocols are followed when cancer patients are tested for venous thromboembolism (VTE). Evidence-based protocols reduce unnecessary diagnostic imaging, offer a patient-centered approach, and have the potential to standardize practice across medical specialties and settings. However, anecdote suggests that specialists who test people with cancer for VTE may prefer diagnostic imaging over clinical probability scoring and D-dimer testing. The aim of this study was to identify physician and patient knowledge, beliefs, values and preferences for VTE testing in cancer. This study was part of a program of research to set International Society of Thrombosis and Haemostasis standards for VTE testing in people with cancer. Methods This was an international qualitative interview study following COREQ guidelines. Semi-structured interviews with physicians and cancer patients were conducted via Zoom. We used purposive sampling to ensure inclusion of physicians from all specialties who test people with cancer for VTE, practicing across all continents. We invited people treated for cancer who had and did not have experience of VTE testing. We used grounded theory to create a conceptual framework which explains physician and patient values and preferences for VTE testing. Transcripts were coded by three researchers independently, who met to discuss their findings and agree on common codes. Researchers were a Thrombosis physician and two undergraduate students who ensured reflexivity was incorporated into their analysis. Results A total of 32 physicians and 6 cancer patients were invited to interview. Of those invited, 23 physicians and 6 patients across 6 continents completed an interview. Interviews lasted between 21 and 86 minutes. Our derived conceptual model can be seen in the attached Figure. Physicians reported a low threshold to test for VTE in people with cancer compared to those without cancer, because VTE was considered a fatal disease and highly prevalent in this patient population. Imaging was generally the only test used for VTE testing in cancer patients. Many participants relied on their Gestalt estimation of VTE probability when deciding whether to order imaging for pulmonary embolism or deep vein thrombosis. Most thought that low Wells score in combination with a negative D-dimer was not sufficiently sensitive to exclude VTE and anticipated the Wells score and D-dimer to be elevated. The Wells scores had poor face validity because they do not include cancer-specific variables and participants hoped to see a more nuanced formal score for VTE testing in cancer patients. Participants believed that their colleagues would support their diagnostic approach. Patients reported they were used to having tests and CT scans. Patients felt it was important for their physicians to prioritize testing for VTE. Patients had full trust and confidence in their physicians' testing decisions, particularly in decisions made by their oncologists. Conclusion Physicians have a low threshold to test people with cancer for VTE and tend not to use clinical probability assessment and D-dimer. Patients are comfortable having diagnostic imaging, feel VTE testing is important and have full trust in their physicians. Figure 1 Figure 1. Disclosures No relevant conflicts of interest to declare.

scholarly journals Reducing ultrasound in diagnosing deep vein thrombosis by using clinical scores and D-dimer testing

2020 ◽  
Vol 7 (2) ◽  
pp. 332
Author(s):  
Nehad Abdou Zaid ◽  
Mahmoud S. El Desoky ◽  
Seham F. Attia
Keyword(s):  
Emergency Department ◽  
University Hospital ◽  
Group 13 ◽  
Vein Thrombosis ◽  
Clinical Probability ◽  
Wells Score ◽  
The Mean ◽  
Deep Vein ◽  
Work Up ◽  
D Dimer

Background: To reduce unnecessary venous ultrasound examination in cases suspected to have deep venous thrombosis (DVT) in emergency department by using D dimer and wells score. venous duplex is widely used to diagnose DVT increasing burden on ultrasound in overcrowded emergency department. Authors can decrease this burden by using clinical probability scores and D dimer.Methods: This is prospective study done on 50 consecutive patients suspected to have DVT represented to emergency department of   Menoufia University Hospital during the period from June 2018 to June 2019. Full history, physical examination, assessment of clinical probability score, d dimer level and results of venous duplex collection.Results: According to wells score, the majority of cases diagnosed as DVT were of high probability group 13(68.4%), 5 patients with moderate probability and only one patient with low probability was diagnosed as DVT. The mean of D dimer level in cases diagnosed as DVT is (4173.6±2173.1) and in cases without DVT is (927.4±1064.6). Using wells score and D dimer together, sensitivity is 100%, Specificity is 94%. PPV is 90%, and NPV is 100% in predicting DVT. All cases with negative d dimer and low risk probability do not have DVT.Conclusions: Based on this result, using wells score and d dimer level in early work up of patients suspected to have DVT will decrease overusing and cost of venous duplex.

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