A negative SimpliRED D-dimer assay result does not exclude the diagnosis of deep vein thrombosis or pulmonary embolus in emergency department patients

STUDY OBJECTIVE: To determine whether a negative SimpliRED D-dimer assay result excludes the diagnosis of deep vein thrombosis (DVT) or pulmonary embolus (PE) in emergency department patients. METHODS: This prospective, institutional review board-approved, clinical trial enrolled consecutive adult ED patients with the suspected diagnosis of venous thromboembolism (VTE) (DVT or PE). Initial ED evaluation included the SimpliRED D-dimer assay (American Diagnostica Inc, Greenwich, CT). Physicians were blinded to assay results. The diagnosis of DVT was made with positive findings on lower-extremity ultrasonography. PE was confirmed by a high-probability ventilation/perfusion (V/Q) scan, a positive pulmonary angiogram, or a positive finding on lower-extremity ultrasonography. A presumptive diagnosis of VTE was made in patients who had VTE at follow-up or unexplained death during the study period. RESULTS: One hundred ninety-eight patients were enrolled during the study period. Twenty-five patients were excluded from data analysis; 9 had no diagnostic testing and 16 were lost to follow-up. Of the 173 patients analyzed, 57 (33%) had VTE-16 of 48 evaluated for DVT and 41 of 125 for suspected PE. The SimpliRED assay had a sensitivity of 65% and a negative predictive value of 81% for detection of VTE. In patients evaluated for DVT alone, the sensitivity was 56% and the negative predictive value was 77%. For patients with suspected PE, the sensitivity and negative predictive value were 68% and 83%, respectively. CONCLUSION: In contrast to earlier reports on the SimpliRED D-dimer assay, a negative result failed to exclude the diagnosis of VTE in our ED population.     

A comparison of three rapid D-dimer methods for the diagnosis of venous thromboembolism

We compared three rapid D-dimer methods for the diagnosis of venous thromboembolism. Patients presenting to four teaching hospitals with the possible diagnosis of deep vein thrombosis or pulmonary embolism were investigated with a combination of clinical likelihood, D-dimer (SimpliRED) and initial non-invasive testing. Patients were assigned as being positive or negative for deep vein thrombosis or pulmonary embolism based on their three-month outcome and initial test results. The three D-dimer methods compared were: (a) Accuclot D-dimer (b) IL-Test D-dimer (c) SimpliRED D-dimer. Of 993 patients, 141 had objectively confirmed deep vein thrombosis or pulmonary embolism. The sensitivity of SimpliRED, Accuclot and IL-Test were 79, 90 and 87% respectively. All three D-dimer tests gave similar negative predictive values. The SimpliRED D-dimer was found to be less sensitive than the Accuclot or IL-Test. When combined with pre-test probability all three methods are probably acceptable for use in the diagnosis of venous thromboembolism.     

Evaluation of an automated latex D-dimer immunoassay in the clinical assessment of suspected venous thromboembolism

Because the reliability of clinical signs in venous thromboembolism (VTE) is poor, a highly sensitive, non-invasive test may improve the selection of patients requiring further investigation. We assessed the sensitivity and negative predictive value of an automated D-dimer latex immunoassay (IL-Test ) in 68 patients presenting with suspected VTE. The plasma D-dimer concentration was estimated and an appropriate diagnostic radiological investigation performed. Control values were obtained from healthy young and elderly volunteers. Using a cut-off value of 330 ng/ml, the assay had a sensitivity of 100% and negative predictive value of 100% for VTE. We conclude that the IL-Test. automated D-dimer assay has a suitably high sensitivity and adequate negative predictive value to be included in a pre-test clinical probability protocol for the evaluation of patients with suspected VTE.     

Decrease in sensitivity of D-dimer for acute venous thromboembolism after starting anticoagulant therapy.

D-dimer testing is useful for the exclusion of acute venous thromboembolism (VTE). Anticoagulant therapy is expected to reduce D-dimer levels in patients with thrombosis and, consequently, it may not be safe to use D-dimer levels to exclude VTE after anticoagulant therapy has been started. The objectives of this study were to estimate the decrease in D-dimer levels after 24 h of heparin therapy and, applying this estimate to the results of a recent study, to calculate the expected reduction in sensitivity. Using pre-defined criteria, we first performed a literature review to determine whether, and by how much, D-dimer levels decrease within 24 h of starting heparin therapy in patients with acute VTE. Using D-dimer levels that were measured in a prospective study of patients with confirmed deep vein thrombosis and/or pulmonary embolism as baselines, we then determined the change in sensitivity (and specificity) that would result from the fall in D-dimer levels that the literature review suggested would have occurred after 24 h of heparin therapy. On the basis of the literature review, we calculated that mean D-dimer levels decrease by 25%, 24 h after starting heparin therapy in patients with acute VTE. This 25% decrease in D-dimer levels resulted in a decrease in sensitivity from 95.6% (95% confidence interval, 90.0-98.6) to 89.4% (95% confidence interval, 83.7-95.1). There is a decrease in D-dimer levels in patients with acute VTE 24 h after starting heparin therapy that is expected to result in a clinically important drop in sensitivity.     

ORIGINAL ARTICLE: Comparison of a point of care device against current laboratory methodology using citrated and EDTA samples for the determination of D-dimers in the exclusion of proximal deep vein thrombosis

D-dimer estimation is a routine part of diagnostic algorithms for the exclusion of venous thromboembolism (VTE). We evaluated a point of care device, Biosite Triage (Inverness Medical UK, Cheshire, UK) for the estimation of D-dimers in both samples taken into citrate and EDTA against our routine laboratory D-dimer (Liatest D-dimer, Diagnostica Stago, Reading, UK) performed on the STA-R Evolution. With informed consent, 102 consecutive patients presenting with possible deep vein thrombosis (DVT) were enrolled and D-dimers along with Wells scores and compression ultrasonography (CUS) were recorded. Using the manufacturers’ recommended cut offs of 500 μg/l fibrinogen equivalent units and 400 μg/l for the Stago and Triage, respectively, sensitivity, specificity, positive and negative predictive values were calculated. These were 1.00, 0.42, 0.17, and 1.00 for the Triage machine using citrate samples, 1.00, 0.32, 0.14, and 1.00 using EDTA samples and 1.00, 0.29, 0.16, and 1.00 for the Stago Liatest assay, respectively. Three patients had significantly higher results for the Stago Liatest D-dimer assay compared with the Biosite Triage device although ultrasound scans were negative. Conclusion: The Biosite Triage D-dimer assay performed on either citrate or EDTA samples is comparable with the Stago Liatest laboratory D-dimer assay when used in conjunction with clinical pretest probability scoring and CUS for the exclusion of DVT.     

Value of D-dimer testing for the exclusion of pulmonary embolism in patients with previous venous thromboembolism

BACKGROUND: D-dimer levels remain elevated in many patients after completion of a 6-month anticoagulant drug course for a first episode of venous thromboembolism (VTE), which may limit the clinical usefulness of D-dimer testing for ruling out a possible recurrence. METHODS: We assessed the safety and usefulness of D-dimer testing in patients with suspected pulmonary embolism (PE) who had experienced a previous VTE. We analyzed data from 2 outcome studies that enrolled 1721 consecutive emergency department patients with clinically suspected PE. Information on the existence of a previous episode of VTE was abstracted from the database. All the patients underwent a sequential diagnostic workup, including an enzyme-linked immunosorbent assay D-dimer test and a 3-month follow-up. RESULTS: The proportion of confirmed PE was 24.1% (415/1719); PE was ruled out by a negative D-dimer test result in 32.7% (462/1411) of the patients without previous VTE but in only 15.9% (49/308) of the patients with previous VTE (P<.001). The 3-month thromboembolic risk was 0% (95% confidence interval, 0.0%-7.9%) in patients with previous VTE and a negative D-dimer test result. The 2-fold lower chance of a negative D-dimer test result in patients with previous VTE was independent of older age, active malignancy, fever, and recent surgery. CONCLUSIONS: In patients with suspected PE and previous VTE, a negative D-dimer test result seems to allow safely ruling out a recurrent event. However, the proportion of negative results is lower in such patients, definitely reducing the clinical usefulness of the D-dimer test in that subgroup.     

D-dimer testing: advantages and limitations in emergency medicine for managing acute venous thromboembolism

D-dimer values can be rapidly determined and used for the management of acute venous thromboembolism (VTE). However, its role in the setting of emergency still remains unclear and inappropriate testing is a significant clinical problem. This review discusses the currently used assays, clinical indications, and limitations of D-dimer measurement. Studies in English language were identified by searching PubMed from December 1985 to December 2005. Available literature on D-dimer was identified from Medline, along with cross referencing from the reference lists of major articles and reviews on this subject. Among 56 articles collected, 14 papers, 4 overviews and 1 systemic review were selected accordingly to predefined criteria. Data synthesis shows that D-dimer testing has sufficient diagnostic accuracy for ruling out acute VTE if used in combination with standardised clinical judgement. D-dimer seems to be also a useful tool for managing suspected VTE patients in absence of immediate imaging. Attention should be paid to exclude conditions that may affect the accuracy of the test, such as concomitant disease, heparin administration and symptom duration >15 days. Although enzyme-linked immunosorbent assay determination has the highest accuracy, immunoturbidimetric assay seems the most suitable on an emergency basis because of its rapid performance. In conclusion, at present D-dimer testing can be safely used in the management of acute VTE in emergency medicine. However, because of its heterogeneity related to the method used and setting implemented, it is preferable to assess D-dimer accuracy before its implementation in management strategies for VTE.     

D-dimer assays for the exclusion of venous thromboembolism

Many assay systems for D-dimer measurement are available. Their intended use is mainly the exclusion of venous thromboembolism (VTE). Despite standardization attempts, an important variability in assay results is observed, and therefore data obtained by use of one assay cannot be extrapolated to another assay. As a consequence, each assay must be validated in appropriate clinical trials to determine its cut-off value for VTE exclusion. The differences observed can be explained by the heterogeneity of fibrin degradation products present in patient samples, by the reactivity of the various antibodies and their combinations, and by the differences in calibrators and in the format of assays. Among the different assay systems available, the use of automated, observer-independent tests having good analytical sensitivity is highly recommended. The assay should also exhibit a high sensitivity for VTE exclusion to be used as the first step of any diagnostic strategy.     

Limitations of D-dimer testing in unselected inpatients with suspected venous thromboembolism

PURPOSE: To determine the utility and limitations of D-dimer testing for the evaluation of venous thromboembolism in hospitalized patients. METHODS: We performed D-dimer testing by four different methods in unselected inpatients undergoing radiologic evaluation for possible venous thromboembolism. We included patients with a history of malignancy, recent surgery, thrombosis, and anticoagulation treatment. C-reactive protein levels were assayed as a measure of inflammation. RESULTS: Of 45 patients with radiographically proven proximal deep venous thrombosis or pulmonary embolism, 43 had elevated D-dimer levels by enzyme-linked immunosorbent assay (ELISA) (sensitivity, 96%); the specificity of the test was 23% (36/157). The qualitative non-ELISA tests had higher specificities, but their sensitivities were <70%. Nineteen patients (42%) with thrombosis had false-negative D-dimer tests by at least one assay. The specificity of the tests decreased with increasing duration of hospitalization, increasing age, and increasing C-reactive protein levels. D-dimer testing had little or no utility in distinguishing patients with thrombosis from those without in patients who had been hospitalized for more than 3 days, were older than 60 years, or had C-reactive protein levels in the highest quartile. CONCLUSION: In unselected inpatients, D-dimer testing has limited clinical utility because of its poor specificity. This is particularly true for older patients, those who have undergone prolonged hospitalization, and those with markedly elevated C-reactive protein levels. In some patient subsets, a negative non-ELISA D-dimer test cannot discriminate between inpatients with and without thrombosis.     

A latex D-dimer reliably excludes venous thromboembolism

BACKGROUND: D-Dimer, a cross-linked fibrin degradation product, has a high sensitivity in patients with suspected venous thrombosis. Traditional latex D-dimer assays, however, have not been sufficiently sensitive to exclude venous thromboembolism. METHODS: To determine the clinical utility of a latex D-dimer assay (MDA D-Dimer; Organon Teknika Corporation, Durham, NC) in patients with suspected venous thromboembolism, we conducted a retrospective cohort study involving 595 unselected patients at 4 tertiary care hospitals. Patients had blood drawn for performance of the D-dimer assay and underwent objective testing for venous thromboembolism. Pretest probability was determined using validated models in 571 patients. Patients were classified as venous thromboembolism positive or negative according to results of objective tests and 3-month follow-up. The sensitivities, specificities, predictive values, and negative likelihood ratios of the assay were calculated for all patients and for subgroups of patients with known cancer or a low, moderate, or high pretest probability of venous thromboembolism. RESULTS: The prevalence of venous thromboembolism was 19.0% (113/595). Of those who had a pretest probability assessment, 35.9% had a low pretest probability, 49.7% a moderate pretest probability, and 14.4% a high pretest probability. Using a discriminant value of 0.50 microg fibrinogen equivalent units per milliliter, the assay showed an overall sensitivity of 96%, a negative predictive value of 98%, a specificity of 45%, and a negative likelihood ratio of 0.09. In patients with a low or moderate pretest probability, the sensitivity, negative predictive value, and negative likelihood ratio were 97%, 99%, and 0.07, respectively. CONCLUSIONS: The MDA D-Dimer assay is the first latex agglutination assay with sufficient sensitivity to be clinically useful in the exclusion of venous thromboembolism. A negative result has the potential to be used as the sole test to exclude venous thromboembolism in patients with a low or moderate pretest probability of disease.     

Accuracy and Precision of a Point-of-Care HbA1c Test

Background:Point-of-care (POC) hemoglobin A1c (HbA1c) testing has advantages over laboratory testing, but some questions have remained regarding the accuracy and precision of these methods. The accuracy and the precision of the POC Afinion™ HbA1c Dx test were investigated.Methods:Samples spanning the assay range were collected from prospectively enrolled subjects at three clinical sites. The accuracy of the POC test using fingerstick and venous whole blood samples was estimated via correlation and bias with respect to values obtained by an NGSP secondary reference laboratory (SRL). The precision of the POC test using fingerstick samples was estimated from duplicate results by calculating the coefficient of variation (CV) and standard deviation (SD), and separated into its components using analysis of variance (ANOVA). The precision of the POC test using venous blood was evaluated from samples run in four replicates on each of three test cartridge lots, twice per day for 10 consecutive days. The SD and CV by study site and overall were calculated.Results:Across the assay range, POC test results from fingerstick and venous whole blood samples were highly correlated with results from the NGSP SRL (r = .99). The mean bias was −0.021% HbA1c (−0.346% relative) using fingerstick samples and −0.005% HbA1c (−0.093% relative) using venous samples. Imprecision ranged from 0.62% to 1.93% CV for fingerstick samples and 1.11% to 1.69% CV for venous samples.Conclusions:The results indicate that the POC test evaluated here is accurate and precise using both fingerstick and venous whole blood.     

The use of a fixed high sensitivity to evaluate five D-dimer assays' ability to rule out deep venous thrombosis: a novel approach

Suspected deep venous thrombosis (DVT) is difficult to refute without complex diagnostic algorithms and expensive testing. We analysed five D-dimer assays' utility for exclusion of suspected DVT during a prospective clinical cohort trial, choosing a highly sensitive cut-off value at which to compare the assays. Assays were performed on 436 consecutive patients who were referred with symptoms that suggested a first episode of DVT. Venous thromboembolism (VTE) was defined as positive findings on comprehensive duplex ultrasonography or any episode, or complication of VTE detected during 3 months of clinical follow-up. All five assays were performed in 377 patients. At a highly sensitive cut-off value, all five assays reliably excluded DVT in the study population. While the choice of a highly sensitive cut-off value reduced the specificity of all the assays, the change in specificity differed between tests. Our findings suggest that a second-generation D-dimer assay could be used as a stand-alone test to rule out suspected DVT when a highly sensitive cut-off value is chosen. These findings should be subjected to a prospective management study, as a small reduction in sensitivity from our findings could result in a clinically relevant decrease in negative predictive value.     

The clinical usefulness of D-dimer testing in cancer patients with suspected deep venous thrombosis

BACKGROUND: Little is known about the diagnostic value of a D-dimer test in cancer patients with clinically suspected deep venous thrombosis (DVT). OBJECTIVE: To evaluate the clinical utility of a whole blood rapid D-dimer test (SimpliRED) in cancer patients compared with noncancer patients. METHODS: In consecutive patients with suspected lower limb DVT, a D-dimer test and ultrasonogram were performed. Cancer status was recorded at presentation. If the D-dimer test and ultrasonogram results were normal, DVT was considered absent. If the D-dimer result was abnormal, ultrasonography was performed again 1 week later. Anticoagulant therapy was only instituted in those patients with an abnormal ultrasonography result. All patients were followed up for 3 months to record subsequent thromboembolic events. The accuracy of the D-dimer test was assessed, and the efficiency and safety of withholding additional ultrasonography in cancer patients with normal results on both D-dimer and ultrasonography was compared with noncancer patients. RESULTS: A total of 1739 consecutive patients were studied, 217 (12%) of whom had cancer. The negative predictive value of the D-dimer test was 97% in both cancer and noncancer patients. In 63 (29%) of all 217 cancer patients, the D-dimer and ultrasonography results were normal at referral; therefore, the diagnosis of DVT was refuted and anticoagulant treatment was withheld. In these 63 patients, one thromboembolic event occurred during follow-up (1.6%; 95% confidence interval, 0.04%-8.53%). CONCLUSIONS: The negative predictive value of a whole blood D-dimer test in cancer patients seems as high as in noncancer patients. In a substantial proportion of cancer patients, the diagnosis can likely be refuted at referral, based on normal D-dimer test and ultrasonogram results. Furthermore, it seems safe to withhold anticoagulant therapy in these patients.     

血栓弹力图对疑似静脉血栓栓塞症患者的诊断价值

目的:探讨血栓弹力图(TEG)对疑似静脉血栓栓塞症(VTE)患者的诊断价值。方法:本研究为病例对照研究,采用非随机抽样的方法收集2018年1月至2020年12月广州医科大学附属第一医院收治的怀疑为急性VTE的普通住院患者752例,按是否确诊VTE分为VTE组103例,非VTE组649例。比较2组静脉血细胞指标红细胞计数...     

Laboratory tests in the diagnosis of pulmonary embolism

The diagnosis of pulmonary embolism (PE) requires objective testing. However, all imaging techniques have their own limitations and costs and cannot be performed in every patient with suspected PE. After decades of unfruitful research, several laboratory tests have been evaluated for suspected PE, the most promising being the D-dimer test. As a general rule, the specificity of D-dimers is too low to confirm PE. Conversely, several (but not all) D-dimer assays have a high sensitivity for diagnosing PE. Outcome studies indicate that the Vidas D-dimer and SimpliRED D-dimer can be used safely to withdraw anticoagulation when the pretest probability of PE is low (SimpliRED) or when it is low or moderate (Vidas). These results may however not apply to other D-dimer assays and clinicians should know the characteristics of the test used in their hospital. Blood gas analysis does not have sufficient sensitivity and specificity to confirm or exclude PE, but it may be used to evaluate the clinical probability of PE before other testing is done. The diagnostic value of the alveolar dead space fraction in patients with suspected PE is currently investigated. Initial data suggest that it needs to be combined with a D-dimer test to safely exclude PE. Brain natriuretic peptide and cardiac troponin have limited usefulness for diagnosing PE, but both tests may identify patients with a poor prognosis, in whom more aggressive treatment may be warranted.     

Comparison of six D-dimer methods in patients suspected of deep vein thrombosis.

We evaluated six D-dimer methods to determine their sensitivity, specificity, and negative predictive values (NPV) in symptomatic patients suspected of deep vein thrombosis (DVT). In patients suspected of DVT a whole blood D-dimer test (SimpliRED, Agen) was performed, and then tested using enzyme-linked immunosorbent assay (VIDAS D-Dimer, BioMerieux; Asserachrome D-Di, Stago International; Dimertest Gold, Agen) and automated immunoturbidometric methods (Advanced D-Dimer, Dade Behring; MiniQuant, Biopool). Each D-dimer method was independently compared with radiographic results to determine sensitivity and NPV. There were 151 patients enrolled in the study. Thirty-five (23.2%) patients had a positive Doppler ultrasound, with 26 proximal, eight distal, and one patient with both proximal and distal thrombus. Two patients (1.3%) had inconclusive studies and were excluded from the analyses. For all patients, the sensitivities for the rapid D-dimer methods were: SimpliRED, 82.3% [95% confidence interval (CI), 80.3-84.3%]; VIDAS D-Dimer, 91.4% (95% CI, 89.9-92.9%); MiniQuant D-Dimer, 96.3% (95% CI, 95.1-97.5%); and Advanced D-Dimer, 97.1% (95% CI, 96.3-97.9%). The sensitivity improved for SimpliRED (86.4%; 95% CI, 83.3-89.4%), VIDAS D-Dimer (95.5%; 95% CI, 85.0-100%), MiniQuant D-Dimer (100%; 95% CI, 96.9-100%) and Advanced D-Dimer (100%; 95% CI, 98.9-100%) in the inpatient population. The automated immunoturbidometric methods, the MiniQuant D-Dimer and Advanced D-Dimer, demonstrated comparable sensitivities and NPV with the VIDAS D-Dimer method in symptomatic patients suspected of DVT, which would suggest that these newer D-dimer methods could be used as part of the diagnostic algorithm for patients suspected of DVT.     

Evaluation of a new automated quantitative d-dimer, Advanced D-Dimer, in patients suspected of venous thromboembolism.

The objective of our study was to evaluate the performance characteristics of a new automated d-dimer, the Advanced D-Dimer (Dade Behring Inc., Deerfield, IL) for use in the diagnosis of venous thromboembolism (VTE). To do this we compared the Advanced D-Dimer to existing d-dimer methods using established target cut-off values in patients suspected of VTE who were to undergo definitive radiographic studies for VTE. We studied hospitalized patients and outpatients who were suspected of having VTE and who had whole blood d-dimer performed. The patients who underwent a diagnostic study for VTE had their D-dimer results used to determine sensitivity, specificity and negative predictive values. There was relatively poor correlation between the Advanced D-Dimer and D-Dimer Gold (r = 0.63; t-test: P < 0.005) and Asserachrome D-Di (r = 0.58; t-test: P < 0.005). The Advanced D-Dimer target cutoff values for excluding VTE in hospitalized and outpatients were < or = 1800 microg/L and < or = 1500 microg/l respectively. There were 139 patients suspected with pulmonary embolism (PE) and 328 evaluated for deep vein thrombosis (DVT). There were 24 patients with PE, and 43 with DVT. The Advanced D-Dimer had comparable sensitivity, specificity and negative predictive values (96, 43, 98% for PE and 96, 48, 99% for DVT respectively) to other d-dimer methods used for that purpose. We conclude that the Advanced D-Dimer correlates relatively poorly with enzyme-linked immunosorbent assay methods. This poor correlation is likely due to incorrect reporting units and concentration. When these factors are corrected correlations improved. Compared to existing d-dimer methods used for VTE exclusion, the high sensitivity and negative predictive value would suggest that this method can be used as part of a diagnostic algorithm for the exclusion of PE and DVT.     

Negative D-dimers and exclusion of venous thromboembolism--own experience

The assessment of D-dimer concentration has become essential step during diagnostic algorithm of venous thromboembolism (VTE). This test characterizes high sensitivity but limited specificity. Negative D-dimer with high probability excludes VTE. The aim of this study was to assess the percentage of patients treated in Department of Internal Medicine, Endocrinology and Haemostatic Disorders, Medical University of Gdańisk, who in spite of clinical signs of VTE showed normal D-dimer level. Between 2000 and 2004 in our department 57 cases with recent deep vein thrombosis (DVT) were diagnosed, in 2 cases with co-existence of pulmonary embolism (PE). The D-dimer concentration was assessed in patients' plasma with the use of immunoturbidometry. Between 57 cases with VTE, 7 patients (12%) showed normal D-dimer level (<500 microg/ml). This group consisted of 4 men and 3 women, aged from 40 to 82 years (the mean age of 58 years). In all 7 cases DVT was diagnosed, in 2 patients with concomitent PE. The final diagnosis was confirmed by compression ultrasonography and pulmonary scintigraphy. Our analysis underlines the observation that occurrence of VTE and negative d-dimer concentration is possible and may probably be related to methodological limitations. However, the lack of increase of D-dimer could also be caused by fibrinolysis alteration.     

High D-dimer levels at presentation in patients with venous thromboembolism is a marker of adverse clinical outcomes

Qualitative D-dimer results, together with clinical probability scores, are well established in the diagnosis of venous thromboembolism (VTE). The predictive value of quantitative D-dimer levels for various clinical outcomes in VTE patients is not fully understood. D-dimer levels obtained at presentation were analysed in 699 (360 men; 339 women) VTE patients for survival and occurrence of malignancy. Patients were followed for a median of 23 months. 17.2% patients had a D-dimer level >8000 ng FEU/mlat presentation, which was associated with decreased overall survival (OS) (P < 0.001) and event-free survival (EFS) (P < 0.001). 25.4% patients had malignancy and 4% subsequently developed malignancy following VTE. 29.9% of patients with VTE and malignancy had a D-dimer level >8 mg/l when compared with 13.4% of patients with VTE without malignancy (P < 0.001). 50% of patients who developed subsequent malignancy following VTE had a presentation D-dimer >8000 ng FEU/mlas compared with 13.3% of patients with VTE with out malignancy (P = 0.009). In conclusion, D-dimer >8000 ng FEU/ml at presentation in patients with VTE is a marker of poor OS, EFS and underlying malignancy. Consideration of screening for malignancy is recommended in patients with VTE with a presentation D-dimer >8000 ng FEU/ml and age >60 years.     

D-dimer for the diagnosis of venous thromboembolism

D-dimer, a breakdown product of cross-linked fibrin has been extensively evaluated as a diagnostic test for acute venous thromboembolism. Rapid, highly sensitive D-dimer assays are now available that are suitable for testing in the emergency setting. Preliminary studies suggest that when using a highly sensitive D-dimer assay, a negative test result may,be sufficient to exclude the diagnosis of venous thromboembolism without need for further testing. Less sensitive, but more specific D-dimer assays are also available. The negative predictive value of these latter assays is insufficient to exclude venous thromboembolism on the basis of a negative test result alone. However, their utility is increased by identifying patient populations at low risk for venous thromboembolism using consideration of clinical probability or radiographic testing. Further, large multicenter management studies are required to confirm the safety of relying on a negative D-dimer result to exclude the diagnosis of venous thromboembolism.