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van CCT (UK)

Evaluatie van biomarkers bij VTE onderzoek; de EVA studie

- candidate number25556
- NTR NumberNTR6348
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR20-nov-2016
- Secondary IDsNL56475.041.16 METC UMC Utrecht nr 16-356/M
- Public TitleEvaluatie van biomarkers bij VTE onderzoek; de EVA studie
- Scientific TitleEvaluation of biomarkers in VTE study; the EVA study
- hypothesis
- Healt Condition(s) or Problem(s) studiedDeep vein thrombosis , Pulmonary embolism, D-dimeer, Primary care, Point-of-Care biomarker
- Inclusion criteriasuspected DVT or PE with a low score on the Clinical Decision Rule
- Exclusion criteriaage below 18, a high score on the CDR, ongoing anticoagulation, unable or unwilling to provide informed consent
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-sep-2016
- planned closingdate1-sep-2017
- Target number of participants750
- InterventionsNone
- Primary outcomeproximal DVT of the leg or Pulmonary Embolism
- Secondary outcomeadditional diagnostic information of (cardiac) biomarkers
- Timepoints3 months
- Trial web site
- statusopen: patient inclusion
- Sponsor/Initiator University Medical Center Utrecht (UMCU)
- Funding
(Source(s) of Monetary or Material Support)
De Friesland Zorgverzekeraar, Roche Diagnostics, Nano-ditech corporation USA
- Publications
- Brief summaryVenous thrombo-embolism (VTE), i.e. deep vein thrombosis (DVT) or pulmonary embolism (PE), poses a major diagnostic challenge for the general practitioner (GP) because signs and symptoms can be non-specific and even often quite minimal. The diagnostic work-up starts with scoring a clinical decision rule (CDR). If the CDR yields a low score (low VTE probability) a negative D-dimer test result can safely rule-out VTE without referral for imaging. However, the usability of this diagnostic approach is hampered in two clinical situations. First, D-dimer levels increase with increasing age (more false positives) and recently an age adjusted cut-off level for D-dimer test results was proposed to increase the diagnostic yield of D-dimer (i.e. better rule-out VTE) in elderly patients. Second, the most important differential diagnosis of VTE is an infectious disease (community-acquired pneumonia in the case of a primary suspicion of PE, or erysipelas in the case of a primary suspicion of DVT). In these cases, due to inflammation, D-dimer levels are also increased, in the absence of VTE, again decreasing the diagnostic yield of D-dimer.

The primary objective of this study is to perform a clinical and analytical validation of novel point-of-care (POC) D-dimer assays, in particular regarding their ability to rule-out VTE using an age-adjusted D-dimer cut-of. Secondary objectives are evaluating the added diagnostic information as obtained from inflammatory biomarkers (C-reactive protein and procalcitonin). Finally, we want to evaluate a novel biomarker for coagulation that has recently been developed (e.g. thrombin-anti-thrombin complex; TAT). We hypothesize that TAT-levels more accurately predict actual coagulation, and thus likely suffer less from false positive findings due to ageing or concurrent infectious diseases. For this purpose additional blood will be sampled and stored centrally in the “biobank” of the UMC Utrecht, allowing for future analyses for emerging novel biomarkers.
- Main changes (audit trail)
- RECORD20-nov-2016 - 1-jun-2017

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