Evaluation of D-dimer ELISA Test in Elderly Patients with Suspected Pulmonary Embolism

1998 ◽  
Vol 79 (01) ◽  
pp. 38-41 ◽  
Author(s):  
Brigitte Tardy-Poncet ◽  
Alain Viallon ◽  
Pierre Lafond ◽  
Y. Page ◽  
Christophe Venet ◽  
...  
Keyword(s):  
Predictive Value ◽  
High Probability ◽  
Elisa Test ◽  
Suspected Pulmonary Embolism ◽  
Duplex Scan ◽  
Vein Thrombosis ◽  
Conventional Elisa ◽  
Deep Vein ◽  
D Dimer

SummaryStudy Objective: To determine the clinical usefulness of D-dimer ELISA test in elderly patients with clinically suspected pulmonary embolism (PE). Design: Prospective cohort study. Patients: Ninety-six consecutive outpatients older than 70 years with a duration of symptoms shorter than one week and without metastatic cancer or recent surgery, trauma, infection, stroke, myocardial infarction, deep vein thrombosis (DVT) or PE, or treatment with curative doses of heparin or oral anticoagulant. Intervention: All patients underwent at least ventilation/perfusion scan and bilateral ultrasonic duplex scan and a blood sample collection within 24 hours of admission. When necessary a pulmonary angiography and/or a bilateral venography were also performed. Patients were classified as follows: (1) PE-positive; positive angiography or high probability V/Q scan and deep vein thrombosis (proven either by venography or by ultrasonic duplex scan) or non high probability V/Q scan and either DVT (proven at presentation by venography or by ultrasonic duplex scan) or symptomatic thromboembolic event within 3 months of follow-up; or (2) PE-negative; normal V/Q scan or normal angiography or non high probability V/Q scan and either negative ultrasonic duplex scan or normal venography and low clinical probability and absence of symptomatic thromboembolism within 3 months of follow-up. D-dimer measurements were performed using both a conventional and a single semi-quantitative ELISA test (Asserachrom D-di, Instant I.A.D-dimer). Results: Using a cutoff value of 500 ng/ml, the conventional ELISA D-dimer test showed a sensitivity and a negative predictive value of 100% with poor specificity and positive predictive value of 14.3% and 45.5% respectively. The new rapid semi-quantitative D-dimer test displays worse results with sensitivity, negative predictive value, specificity and positive predictive value of 92.3%, 82.4%, 25% and 46% respectively. Conclusion: In a geriatric population, conventional ELISA D-dimer is a good marker to exclude PE but, due to the comorbid conditions, only a few patients presented with D-dimer values less than 500 ng/ml.

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 Residual Vein Thrombosis Echogenicity Is Associated to the Risk of DVT Recurrence: A Cohort Study

2017 ◽  
Vol 24 (3) ◽  
pp. 477-482 ◽  
Author(s):  
Bruna M. Mazetto ◽  
Fernanda L. A. Orsi ◽  
Sandra A. F. Silveira ◽  
Luis F. Bittar ◽  
Mariane M. C. Flores-Nascimento ◽  
...  
Keyword(s):  
Deep Vein Thrombosis ◽  
Negative Predictive Value ◽  
Predictive Value ◽  
Late Complication ◽  
Predictive Marker ◽  
Predictive Markers ◽  
Vein Thrombosis ◽  
Deep Vein ◽  
D Dimer

Although deep vein thrombosis (DVT) recurrence is a common late complication of the disease, there are few predictive markers to risk-stratify patients long-term after the thrombotic event. The accuracy of residual vein thrombosis (RVT) in this context is controversial, possibly due to a lack of a standardized methodology. The objective of the study was to evaluate the accuracy of RVT echogenicity as a predictive marker of late DVT recurrence. To evaluate the accuracy of RVT echogenicity as a predictive marker of late DVT recurrence. This prospective study included patients with history of DVT in the past 33 months. Ultrasound examination was performed to detect the presence of RVT, and its echogenicity was determined by calculating the grayscale median (GSM) of the images. Blood samplings were taken for plasma D-dimer levels. Patients were followed-up for 28 months and the primary end point was DVT recurrence. Deep vein thrombosis recurrence was confirmed or excluded by ultrasound during the follow-up. Fifty-six patients were included, of which 10 presented DVT recurrence during the follow-up. D-dimer levels above 630 ng/mL conferred higher risk for recurrence with a negative predictive value of 94%. The absence of RVT was a protective marker for recurrence with a negative predictive value of 100%. Also, the presence of hypoechoic RVT, determined by GSM values below 24, positively predicted 75% of DVT recurrences. Our results suggest that the persistence of RVT and, particularly, the presence of hypoechoic thrombi (GSM < 24) are predictive markers of the risk of DVT recurrence. Residual vein thrombosis echogenicity, by GSM analysis, could represent a new strategy for the evaluation of recurrence risk in patients with DVT.

Positive Predictive Value of Progressively Elevated D-Dimer Levels in Patients with a Suspected First Deep Vein Thrombosis.

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 2258-2258
Author(s):  
Sarah Louise Dunbar Takach Lapner ◽  
Lori Ann Linkins ◽  
Shannon M. Bates ◽  
Jim Julian ◽  
James D. Douketis ◽  
...  
Keyword(s):  
Deep Vein Thrombosis ◽  
Positive Predictive Value ◽  
Positive Result ◽  
Predictive Value ◽  
Progressive Increase ◽  
Likelihood Ratios ◽  
Vein Thrombosis ◽  
Deep Vein ◽  
D Dimer

Abstract Abstract 2258 Background D-dimer is nearly always increased in patients with acute venous thromboembolism (VTE) and, therefore, a low value (i.e., negative test) has high negative predictive value. A positive result indicates the need for further diagnostic testing (e.g. ultrasound imaging if deep vein thrombosis is suspected), but it is generally believed that the predictive value of a positive result is of no clinical value. While this is true if D-dimer values are dichotomized as positive or negative, D-dimer may have diagnostically useful positive predictive value when levels are markedly elevated (i.e., positive results are not considered as a single category). Objective To determine the prevalence of, and likelihood ratios for, deep vein thrombosis (DVT) associated with progressively elevated D-dimer levels in patients with a suspected first DVT. Methods We performed a retrospective analysis of D-dimer level from 1224 banked peripheral blood samples from participants enrolled at 4 of the 5 participating clinical centres in the recently competed SELECT study, which compared two diagnostic strategies in patients with a suspected first DVT. D-dimer levels were measured using the Triage® D-dimer assay. The clinical pretest probability (CPTP) was determined in all patients using the 9 point Wells score and categorized as low, moderate or high. Patients were categorized as DVT positive if DVT was diagnosed by lower limb ultrasound (US) at initial presentation or VTE was diagnosed during three months of follow-up. Patients were categorized as DVT negative if DVT was not diagnosed at initial assessment (patients with low CPTP and negative D-dimer results did not undergo US) and there was no VTE during three months of follow-up. The diagnosis or exclusion of DVT was made independently of the Triage® D-dimer measurements (a different D-dimer assay was used at presentation in the SELECT study, and D-dimer was not used to evaluate suspected VTE during the 3 month follow-up). The prevalence of DVT and likelihood ratios (LHR) for all patients, and according to CPTP (low, moderate or high), was determined for the following intervals of D-dimer level: <500ug/L, 500–1000ug/L, 1001–1500ug/L, 1501–2000ug/L, 2001–3000 ug/L, 3001–4000ug/L, 4001ug/L-5000ug/L and >5000ug/L. Results The prevalence of DVT, and associated LHR, among all patients increased steadily with rising D-dimer levels (Table 1). At values of less than 1000ug/L, the prevalence of DVT among all patients was low (0.15% for D-dimer <500ug/L and 1.2% for 500–1000ug/L). However, at levels above 1500ug/L there was a progressive increase in the prevalence from 14.3% for 1500–2000ug/L to 64.0% at levels >5000ug/L. The associated likelihood ratios for DVT also increased according to D-dimer level from 2.6 for levels of 1500–2000ug/L to 28.0 for values >5000ug/L. The prevalence of DVT was 2.6% for patients with low CPTP, 6.0% among those with moderate CPTP and 22.0% among patients with high CPTP. The increase in prevalence and associated LHR for DVT with increasing D-dimer levels was consistent across all three CPTP groups. Conclusion Increasing D-dimer levels are associated with a progressive increase in prevalence and LHR for DVT across all clinical pretest probability strata. The positive predictive value of markedly elevated D-dimer levels was high and may help to identify the subgroup of patients with an abnormal D-dimer level who require more intensive investigation after a normal imaging test. Disclosures: Bates: Trinity Biotech: Consultancy, consultation fees and in-kind support (D-dimer kits) Other. Kearon:Alere: Consultancy.

Application of a Diagnostic Clinical Model for the Management of Hospitalized Patients with Suspected Deep-vein Thrombosis

1999 ◽  
Vol 81 (04) ◽  
pp. 493-497 ◽  
Author(s):  
Philip S. Wells ◽  
David R. Anderson ◽  
Janis Bormanis ◽  
Fred Guy ◽  
Michael Mitchell ◽  
...  
Keyword(s):  
Deep Vein Thrombosis ◽  
Predictive Value ◽  
Hospitalized Patients ◽  
Pretest Probability ◽  
Clinical Model ◽  
Vein Thrombosis ◽  
Deep Vein ◽  
D Dimer ◽  
High Pretest Probability

SummaryThe purpose of this study was to evaluate whether the determination of pretest probability using a simple clinical model and the SimpliRED D-dimer could be used to improve the management of hospitalized patients with suspected deep-vein thrombosis. Consecutive hospitalized patients with suspected deep-vein thrombosis, had their pretest probability determined using a clinical model and had a SimpliRED D-dimer assay. Patients at low pretest probability underwent a single ultrasound test. A negative ultrasound excluded the diagnosis of deep-vein thrombosis whereas a positive ultrasound was confirmed by venography. Patients at moderate pretest probability with a positive ultrasound were treated for deep-vein thrombosis whereas patients with an initial negative ultrasound underwent a single follow-up ultrasound one week later. Patients at high pretest probability with a positive ultrasound were treated whereas those with negative ultrasound underwent venography. All patients were followed for three months for the development of venous thromboembolic complications. Overall, 28% (42/150), and 10% (5/50), 21% (14/71) and 76% (22/29) of the low, moderate and high pretest probability patients, respectively, had deep vein thrombosis. Two of 111 (1.8%; 95% CI = 0.02% to 6.4%) patients considered to have deep vein thrombosis excluded had events during three-month follow-up. Overall 13 of 150 (8.7%) required venography and serial testing was limited to 58 of 150 (38.7%) patients. The negative predictive value of the SimpliRED D-dimer in patients with low pretest probability was 96.2%, which is not statistically different from the negative predictive value of a negative ultrasound result in low pretest probability patients (97.8%). Management of hospitalized patients with suspected deep-vein thrombosis based on clinical probability and ultrasound of the proximal deep veins is safe and feasible.Dr. Philip Wells and Dr. David Anderson are the recipients of Research Scholarships from the Heart and Stroke Foundation of Canada.

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

1996 ◽  
Vol 75 (03) ◽  
pp. 412-416 ◽  
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.

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

1996 ◽  
Vol 76 (04) ◽  
pp. 518-522 ◽  
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.

Risk of Venous Thromboembolism Recurrence: High Negative Predictive Value of D-dimer Performed after Oral Anticoagulation Is Stopped

2002 ◽  
Vol 87 (01) ◽  
pp. 7-12 ◽  
Author(s):  
Cristina Legnani ◽  
Benilde Cosmi ◽  
Giuliana Guazzaloca ◽  
Claudia Pancani ◽  
Sergio Coccheri ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
Negative Predictive Value ◽  
Predictive Value ◽  
Recurrent Events ◽  
Oral Anticoagulant Therapy ◽  
Lower Limbs ◽  
First Episode ◽  
Vein Thrombosis ◽  
D Dimer

SummaryIn some patients with previous venous thromboembolism (VTE) D-dimer levels (D-Dimer) tend to increase after oral anticoagulant therapy (OAT) is stopped. The aim of our study was to evaluate the predictive value of D-Dimer for the risk of VTE recurrence after OAT withdrawal. After a first episode of deep vein thrombosis (DVT) of the lower limbs and/or pulmonary embolism (PE), 396 patients (median age 67 years, 198 males) were followed from the day of OAT discontinuation for 21 months. D-dimer was measured on the day of OAT withdrawal (T1), 3-4 weeks (T2) and 3 months (+/− 10 days, T3) thereafter. The main outcome events of the study were: objectively documented recurrent DVT and/or PE. D-dimer was found to be increased in 15.5%, 40.3% and 46.2% of the patients at T1, T2 and T3, respectively. In 199 (50.2%) patients, D-dimer levels were elevated in at least one measurement. During a follow-up of 628.4 years, 40 recurrences were recorded (10.1% of patients; 6.4% patient-years of follow-up). D-dimer was increased in at least one measurement in 28 of these cases, but remained normal in 11 subjects (three of whom had recurrent events triggered by circumstantial factors, three with malignancyassociated factors) (in one subject D-dimer was not measured). The negative predictive value (NPV) of D-dimer was 95.6% (95% CI 91.6-98.1) at T3 and was even higher (96.7%; 95% CI 92.9-98.8) after exclusion of the six recurrences due to circumstantial factors. Only five idiopathic recurrences occurred in the 186 patients with consistently normal D-dimer. In conclusion, D-dimer has a high NPV for VTE recurrence when performed after OAT discontinuation.

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 Risk of Deep Vein Thrombosis After Acute Achilles Tendon Rupture: A Secondary Analysis of a Randomized Controlled Trial Comparing Early Controlled Motion of the Ankle Versus Immobilization

2020 ◽  
Vol 8 (4) ◽  
pp. 232596712091590 ◽  
Author(s):  
Kristoffer Weisskirchner Barfod ◽  
Emil Graakjær Nielsen ◽  
Beth Hærsted Olsen ◽  
Pablo Gustavo Vinicoff ◽  
Anders Troelsen ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Achilles Tendon ◽  
Tendon Rupture ◽  
Controlled Trial ◽  
Achilles Tendon Rupture ◽  
Vein Thrombosis ◽  
Randomized Controlled ◽  
Deep Vein ◽  
D Dimer

Background: Immobilization of the ankle joint has been suggested as a key element in the pathogenesis leading to deep vein thrombosis (DVT). Purpose: To investigate whether early controlled ankle motion (ECM) could reduce the incidence of DVT compared with immobilization (IM) in the treatment of acute Achilles tendon rupture. Study Design: Randomized controlled trial; Level of evidence, 2. Methods: Patients aged 18 to 70 years were eligible for inclusion, and treatment was nonoperative. The ECM group performed movements of the ankle 5 times a day from weeks 3 to 8 after rupture. The control group was immobilized for 8 weeks. The outcome measure was DVT diagnosed with color Doppler ultrasound for above- and below-knee DVT at 2 and 8 weeks. The Achilles tendon Total Rupture Score, the heel-rise work test, and the Copenhagen Achilles ultrasonographic Length Measurement were performed at 4-, 6-, and 12-month follow-up. Results: A total of 189 patients were assessed for eligibility from February 2014 to December 2016. Of these, 130 were randomized: 68 patients were allocated to the ECM group and 62 to the IM group. All patients participated in follow-up at 8 weeks assessing for DVT. In total, 62 (47.7%) patients were diagnosed with DVT: 33 of 68 (48.5%) in the ECM group and 28 of 61 (46.8%) in the IM group ( P = .84). DVT did not affect treatment outcomes at 4, 6, and 12 months. D-dimer had low sensitivity (71%) for detecting DVT. Conclusion: We found that 1 in 2 patients presented with DVT in nonoperative treatment of acute Achilles tendon rupture. The ECM protocol revealed no benefit versus IM in reducing the incidence of DVT. DVT did not influence functional and patient-reported outcomes the first year after rupture. D-dimer seems an inappropriate test for detection of DVT in patients with acute Achilles tendon rupture. Registration: NCT02015364 ( ClinicalTrials.gov identifier).

Evidence for Safe Exclusion of Deep Vein Thrombosis (DVT) by a Rapid ELISA D-Dimeer Test at Cut-Off Levels of 500 and 1000 Ng/Ml in 1046 Consecutive Outpatients with Suspected DVT.

Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 1059-1059
Author(s):  
Jan Jacques Michels ◽  
Jan Hermssen ◽  
Paul H. Trienekens
Keyword(s):  
Deep Vein Thrombosis ◽  
Negative Predictive Value ◽  
Predictive Value ◽  
Clinical Score ◽  
Large Prospective Study ◽  
Vein Thrombosis ◽  
Persistent Symptoms ◽  
Deep Vein ◽  
D Dimer ◽  
Compression Ultrasonography

Abstract Introduction.A normal compression ultrasonography (CUS) safely excludes proximal deep vein thrombosis (DVT) with a negative predictive value of 97% indicating the need to repeat CUS testing within one week. In 3 studies, the rapid ELISA D-dimer assay at a cut-off of 500 ng/ml did have a sensitivity of 100% for the exclusion of venographically documented distal and proximal DVT irrespective of clinical score. To test this hypothesis we performed a large prospective study in outpatients with suspected DVT. Methods. CUS and a rapid ELISA D-Dimer test (VIDAS, BioMérieux L’Etoile, France) were performed in patients with suspected DVT. A negative CUS with a D-Dimer result of <500 ng/ml exclude DVT, and with a D-Dimer result of >500 ng/ml was followed by a second CUS within one week. Results. The prevalence of DVT 1046 consecutive out patients with suspected DVT was 23,4%. The first CUS was positive in 228 with a rapid ELISA D-Dimer of >500 ng/ml in 227 and of <500 ng/ml in one case, indicating a sensitivity of 99,6% irrespective of clinical score. The first CUS was negative in 818. The rapid ELISA D-dimer test Was <500 ng/ml in 297 of which 296 had a negative first CUS indicating a negative predictive value of 99.7% at a specificity of 37% irrespective of the clinicl score. The negative predictive value of a negative CUS plus a rapid ELISA D-Dimer result of less than 1000 ng/ml is 99.5% at a specificity of 67,9% irrespective of clinical score. The prevalence of DVT in patients with negative first CUS and a ELISA D-Dimer of >1000 ng/ml was 5.6% as documented by CUS repeat within on week. Conclusion.A normal rapid ELISA D-dimer test, <500 ng/ml, in outpatients with suspected DVT safely excludes DVT irrespective of clinical score. After a negative rapid ELISA result (<500 ng/ml), CUS is still indicated for safety reasons in patients with suspected DVT and persistent symptoms in search for an alternative diagnosis, or for a rare case of DVT. A negative CUS plus and ELISA D-Dimer result of <1000 ng/ml safely exclude DVT without the need to repeat CUS in 2/3 of patients with a negative first CUS.

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