Strategies for the Safe and Effective Exclusion and Diagnosis of Deep Vein Thrombosis by the Sequential Use of Clinical Score, D-Dimer Testing, and Compression Ultrasonography

2000 ◽  
Vol 26 (06) ◽  
pp. 657-668 ◽  
Author(s):  
Jan Jacques Michiels ◽  
Geneviéve Freyburger ◽  
Fedde Van Der Graaf ◽  
Mirian Janssen ◽  
Wija Oortwijn ◽  
...  
Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 1059-1059
Author(s):  
Jan Jacques Michels ◽  
Jan Hermssen ◽  
Paul H. Trienekens

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.


2020 ◽  
Vol 4 (20) ◽  
pp. 5002-5010
Author(s):  
Synne G. Fronas ◽  
Camilla T. Jørgensen ◽  
Anders E. A. Dahm ◽  
Hilde S. Wik ◽  
Jostein Gleditsch ◽  
...  

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.


2018 ◽  
Vol 146 (5-6) ◽  
pp. 303-308
Author(s):  
Dragan Markovic ◽  
Dragan Vasic ◽  
Jelena Basic ◽  
Slobodan Tanaskovic ◽  
Slobodan Cvetkovic ◽  
...  

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.


2021 ◽  
Author(s):  
Keisuke Miyamoto ◽  
Hiroaki Komatsu ◽  
Masayo Okawa ◽  
Yuki Iida ◽  
Daiken Osaku ◽  
...  

Abstract BackgroundVenous thromboembolism often develops after surgery and childbirth, resulting in death in some cases. Although early deep vein thrombosis (DVT) detection can predict pulmonary thromboembolism, there is no early screening method for DVT in pregnant women. Lack of consensus regarding significance or setting and cut-off value interpretation of D-dimer levels further impedes venous thromboembolism screening in pregnant women.This study aimed to examine the utility of third-trimester serum D-dimer levels for screening test for DVT during pregnancy.to determine the frequency of asymptomatic DVT using lower-limb compression ultrasonography.MethodsThis single-center retrospective study included 497 pregnant women who underwent elective cesarean section at term in our hospital between January 2013 and December 2019. Serum D-dimer levels were preoperatively measured at 32–37 gestation weeks. The presence or absence of DVT in patients with serum D-dimer levels ≥ 3.0 µg/ml, the cut-off value, was examined using compression ultrasonography. In all patients, the presence or absence of clinical venous thrombosis (symptoms such as lower-limb pain, swelling, and heat sensation) was examined within 4 postoperative weeks.The Royal College of Obstetricians and Gynecologists Guideline 2015 was referred to determine risk factors for the onset of venous thrombosis during pregnancy. Among those, we examined the risk factors for DVT that result in high D-dimer levels during pregnancy.ResultsThe median age and body mass index were 35 (20–47) years and 21.2 (16.4–41.1) kg/m2, respectively. Further, the median gestational age and D-dimer levels were 37 weeks and 2.1 (0.2–16.0) µg/ml, respectively. Compression ultrasonography was performed on 135 (26.5%) patients with a D-dimer level ≥3.0 µg/ml, with none of the patients showing DVT. All patients were followed up for 4 postoperative weeks, with none presenting with venous thromboembolism. Multivariate analysis showed that hypertensive disorders of pregnancy is an independent risk factor for venous thromboembolism that causes high D-dimer levels (odds ratio: 2.48, 95% confidence interval: 1.05–6.50, P=0.04).ConclusionThere may be low utility in screening for DVT using D-dimer levels in the third trimester. Further, prepartum asymptomatic DVT has a low frequency, indicating the low utility of compression ultrasonography.Trial registrationInstitutional Review Board of Tottori University Hospital (IRB no. 20A149).


2007 ◽  
Vol 97 (05) ◽  
pp. 807-813 ◽  
Author(s):  
Fred Haas ◽  
Mariette Agterof ◽  
Marike Vos ◽  
Douwe Biesma ◽  
Roger Schutgens

SummaryDespite the use of a clinical score and D-dimers to exclude deep vein thrombosis (DVT), the majority of patients still need repeated ultrasound (US).The aim of the study was to investigate whether fibrin monomers (FMs), as markers of thrombin generation, have additional value in the diagnosis of DVT. This is a posthoc analysis of 464 outpatients, participants in a management study using D-dimers (Tina-Quant® ) and a clinical score in the exclusion of DVT. Two new FM assays (Auto LIA-FM® and IATRO SF®, Japan) were performed. Overall sensitivity, negative predictive value (NPV) and specificity of the D-dimer test were 98%, 98% and 42%.The optimal cut-off point for the Auto LIAFM test was ≤ 3 µ g/ml with values of 88%, 88% and 59%, respectively. The IATRO SF test had an optimal cut-off point of ≤ 2 µ g/ ml with values of 92%, 81 and 22%, respectively.The NPV of a non-high clinical score and a normal D-dimer (n=97) was 100%. In patients with a high clinical score (n=160), the NPV of the D-dimer was 88%. In these patients, a single US combined with a normal D-dimer or FM test had an equal NPV as serial US (100 versus 98%, respectively) and lead to a reduction in the need for US by 36–53%, respectively. In patients with abnormal D-dimer concentrations (n=343), a normal US combined with a normal Auto LIA-FM test had a NPV of 97%,which was also true for serial US.This could lead to a reduction in the need for US by 45%. The present studied FMs are inferior to theTina-Quant D-dimer test when used as primary screening tool to exclude DVT.Adding these FMs to patients with a normal Tina-Quant D-dimer has no benefit. In patients with a high pretest clinical probability score, a single US in combination with a normal D-dimer or FM test might be as safe as serial US. In patients with abnormal D-dimer concentrations and a normal US, a normal FM test might be able to replace the second US.


Sign in / Sign up

Export Citation Format

Share Document