Rationale and design of three observational, prospective cohort studies including biobanking to evaluate and improve diagnostics, management strategies and risk stratification in venous thromboembolism: the VTEval Project

Bernd Frank, Liana Ariza, Heidrun Lamparter, Vera Grossmann, Jürgen H Prochaska, Alexander Ullmann, Florentina Kindler, Gerhard Weisser, Ulrich Walter, Karl J Lackner, Christine Espinola-Klein, Thomas Münzel, Stavros V Konstantinides, Philipp S Wild, VTEval study group, Philipp S Wild, Stavros V Konstantinides, Thomas Münzel, Karl J Lackner, Christine Espinola-Klein, Philipp S Wild, Stavros V Konstantinides, Bernd Frank, Bernd Frank, Liana Ariza, Heidrun Lamparter, Vera Grossmann, Jürgen H Prochaska, Alexander Ullmann, Florentina Kindler, Gerhard Weisser, Ulrich Walter, Karl J Lackner, Christine Espinola-Klein, Thomas Münzel, Stavros V Konstantinides, Philipp S Wild, VTEval study group, Philipp S Wild, Stavros V Konstantinides, Thomas Münzel, Karl J Lackner, Christine Espinola-Klein, Philipp S Wild, Stavros V Konstantinides, Bernd Frank

Abstract

Introduction: Venous thromboembolism (VTE) with its two manifestations deep vein thrombosis (DVT) and pulmonary embolism (PE) is a major public health problem. The VTEval Project aims to investigate numerous research questions on diagnosis, clinical management, treatment and prognosis of VTE, which have remained uncertain to date.

Methods and analysis: The VTEval Project consists of three observational, prospective cohort studies on VTE comprising cohorts of individuals with a clinical suspicion of acute PE (with or without DVT), with a clinical suspicion of acute DVT (without symptomatic PE) and with an incidental diagnosis of VTE (PE or DVT). The VTEval Project expects to enrol a total of approximately 2000 individuals with subsequent active and passive follow-up investigations over a time period of 5 years per participant. Time points for active follow-up investigations are at months 3, 6, 12, 24 and 36 after diagnosis (depending on the disease cohort); passive follow-up investigations via registry offices and the cancer registry are performed 48 and 60 months after diagnosis for all participants. Primary short-term outcome is defined by overall mortality (PE-related death and all other causes of death), primary long-term outcome by symptomatic VTE (PE-related death, recurrence of non-fatal PE or DVT). The VTEval Project includes three 'all-comer' studies and involves the standardised acquisition of high-quality data, covering the systematic assessment of VTE including symptoms, risk profile, psychosocial, environmental and lifestyle factors as well as clinical and subclinical disease, and it builds up a large state-of-the-art biorepository containing various materials from serial blood samplings.

Ethics and dissemination: The VTEval Project has been approved by the local data safety commissioner and the responsible ethics committee (reference no. 837.320.12 (8421-F)). Trial results will be published in peer-reviewed journals and presented at national and international scientific meetings.

Trial registration number: NCT02156401.

Keywords: Biobanking; Cohort study design; Deep vein thrombosis; Diagnosis; Pulmonary embolism; Venous thromboembolism.

Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Figures

Figure 1
Figure 1
(A) Definition for clinical suspicion of acute PE. PE, pulmonary embolism; RV, right ventricular. (B) Definition for clinical suspicion of acute DVT. DVT, deep vein thrombosis. (C) Definition for clinical suspicion of incidental VTE. DVT, deep vein thrombosis; PE, pulmonary embolism; VTE, venous thromboembolism.
Figure 2
Figure 2
Flow chart of the VTEval Project.
Figure 3
Figure 3
Description of the VTEval Project cohorts (from patient admission to follow-up examinations). CATI, computer-assisted telephone interview; DVT, deep vein thrombosis; PE, pulmonary embolism; VTE, venous thromboembolism.
Figure 4
Figure 4
Standard operating procedure (SOP) and risk-adjusted therapeutic strategies in acute pulmonary embolism. CTPA, computed tomographic pulmonary angiography; DOAC, direct oral anticoagulant; Fonda, fondaparinux; i.v., intravenous; LMWH, low-molecular-weight heparin; PE, pulmonary embolism; PFO, patent foramen ovale; RA, right atrial; rtPA, recombinant tissue plasminogen activator; RV, right ventricular; s.c., subcutanous; UFH, unfractionated heparin.
Figure 5
Figure 5
Standard operating procedure (SOP) and risk-adjusted therapeutic strategies in acute deep vein thrombosis. DVT, deep vein thrombosis.

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