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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

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...

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Autores principales: Frank, Bernd, Ariza, Liana, Lamparter, Heidrun, Grossmann, Vera, Prochaska, Jürgen H, Ullmann, Alexander, Kindler, Florentina, Weisser, Gerhard, Walter, Ulrich, Lackner, Karl J, Espinola-Klein, Christine, Münzel, Thomas, Konstantinides, Stavros V, Wild, Philipp S
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2015
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4499722/
https://www.ncbi.nlm.nih.gov/pubmed/26133379
http://dx.doi.org/10.1136/bmjopen-2015-008157
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author Frank, Bernd
Ariza, Liana
Lamparter, Heidrun
Grossmann, Vera
Prochaska, Jürgen H
Ullmann, Alexander
Kindler, Florentina
Weisser, Gerhard
Walter, Ulrich
Lackner, Karl J
Espinola-Klein, Christine
Münzel, Thomas
Konstantinides, Stavros V
Wild, Philipp S
author_facet Frank, Bernd
Ariza, Liana
Lamparter, Heidrun
Grossmann, Vera
Prochaska, Jürgen H
Ullmann, Alexander
Kindler, Florentina
Weisser, Gerhard
Walter, Ulrich
Lackner, Karl J
Espinola-Klein, Christine
Münzel, Thomas
Konstantinides, Stavros V
Wild, Philipp S
author_sort Frank, Bernd
collection PubMed
description 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.
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spelling pubmed-44997222015-07-15 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 Frank, Bernd Ariza, Liana Lamparter, Heidrun Grossmann, Vera Prochaska, Jürgen H Ullmann, Alexander Kindler, Florentina Weisser, Gerhard Walter, Ulrich Lackner, Karl J Espinola-Klein, Christine Münzel, Thomas Konstantinides, Stavros V Wild, Philipp S BMJ Open Cardiovascular Medicine 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. BMJ Publishing Group 2015-07-01 /pmc/articles/PMC4499722/ /pubmed/26133379 http://dx.doi.org/10.1136/bmjopen-2015-008157 Text en 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 This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
spellingShingle Cardiovascular Medicine
Frank, Bernd
Ariza, Liana
Lamparter, Heidrun
Grossmann, Vera
Prochaska, Jürgen H
Ullmann, Alexander
Kindler, Florentina
Weisser, Gerhard
Walter, Ulrich
Lackner, Karl J
Espinola-Klein, Christine
Münzel, Thomas
Konstantinides, Stavros V
Wild, Philipp S
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
title 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
topic Cardiovascular Medicine
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4499722/
https://www.ncbi.nlm.nih.gov/pubmed/26133379
http://dx.doi.org/10.1136/bmjopen-2015-008157
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