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.
abstract: BACKGROUND
  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
  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.
  
  
  BACKGROUND
  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.
  
  
  BACKGROUND
  NCT02156401.
authors.affiliation: Center for Thrombosis and Hemostasis (CTH), University Medical Center Mainz, Mainz, Germany.
authors.forename: Bernd
authors.initials: B
authors.lastname: Frank
authors.affiliation: Center for Thrombosis and Hemostasis (CTH), University Medical Center Mainz, Mainz, Germany.
authors.forename: Liana
authors.initials: L
authors.lastname: Ariza
authors.affiliation: Center for Thrombosis and Hemostasis (CTH), University Medical Center Mainz, Mainz, Germany.
authors.forename: Heidrun
authors.initials: H
authors.lastname: Lamparter
authors.affiliation: Center for Thrombosis and Hemostasis (CTH), University Medical Center Mainz, Mainz, Germany.
authors.forename: Vera
authors.initials: V
authors.lastname: Grossmann
authors.affiliation: Center for Thrombosis and Hemostasis (CTH), University Medical Center Mainz, Mainz, Germany Department of Medicine 2, University Medical Center Mainz, Mainz, Germany.
authors.forename: Jürgen H
authors.initials: JH
authors.lastname: Prochaska
authors.affiliation: Center for Thrombosis and Hemostasis (CTH), University Medical Center Mainz, Mainz, Germany.
authors.forename: Alexander
authors.initials: A
authors.lastname: Ullmann
authors.affiliation: Center for Thrombosis and Hemostasis (CTH), University Medical Center Mainz, Mainz, Germany.
authors.forename: Florentina
authors.initials: F
authors.lastname: Kindler
authors.affiliation: Department of Medicine 2, University Medical Center Mainz, Mainz, Germany.
authors.forename: Gerhard
authors.initials: G
authors.lastname: Weisser
authors.affiliation: Center for Thrombosis and Hemostasis (CTH), University Medical Center Mainz, Mainz, Germany.
authors.forename: Ulrich
authors.initials: U
authors.lastname: Walter
authors.affiliation: Institute of Clinical Chemistry and Laboratory Medicine, University Medical Center Mainz, Mainz, Germany.
authors.forename: Karl J
authors.initials: KJ
authors.lastname: Lackner
authors.affiliation: Department of Medicine 2, University Medical Center Mainz, Mainz, Germany.
authors.forename: Christine
authors.initials: C
authors.lastname: Espinola-Klein
authors.affiliation: Department of Medicine 2, University Medical Center Mainz, Mainz, Germany German Center for Cardiovascular Research (DZHK), partner site RhineMain, Mainz, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Münzel
authors.affiliation: Center for Thrombosis and Hemostasis (CTH), University Medical Center Mainz, Mainz, Germany.
authors.forename: Stavros V
authors.initials: SV
authors.lastname: Konstantinides
authors.affiliation: Center for Thrombosis and Hemostasis (CTH), University Medical Center Mainz, Mainz, Germany Preventive Cardiology and Preventive Medicine, Department of Medicine 2, University Medical Center Mainz, Mainz, Germany German Center for Cardiovascular Research (DZHK), partner site RhineMain, Mainz, Germany.
authors.forename: Philipp S
authors.initials: PS
authors.lastname: Wild
mesh_terms: D018070:Biological Specimen Banks; D015415:Biomarkers; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008019:Life Style; D008297:Male; D011446:Prospective Studies; D011655:Pulmonary Embolism / Q000175:diagnosis* / Q000628:therapy*; D012107:Research Design; D018570:Risk Assessment; D012307:Risk Factors; D016896:Treatment Outcome; D054556:Venous Thromboembolism / Q000175:diagnosis* / Q000209:etiology / Q000523:psychology / Q000628:therapy*; D020246:Venous Thrombosis / Q000175:diagnosis* / Q000628:therapy*
chemical_list: D015415:Biomarkers
keywords: Biobanking; Cohort study design; Deep vein thrombosis; Diagnosis; Pulmonary embolism; Venous thromboembolism