Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE), Venous Thromboembolism (VTE)
Conditions
Keywords
Venous thromboembolism, Deep vein thrombosis, Pulmonary embolism, Cohort study/epidemiology, Outcome, Prognosis
Brief summary
Venous thromboembolism (VTE) with its two clinical manifestations deep vein thrombosis (DVT) and pulmonary embolism (PE) is a life-threatening disease that is associated with considerable morbidity and mortality. The incidence of VTE increases with age and it - as the third most common cardiovascular disease after ischemic heart disease and stroke - represents an important public health problem in industrialized countries with several aspects in need to be addressed. VTEval Project includes three long-term prospective observational studies to evaluate and improve VTE diagnostics and management, treatment and outcome. The aims of the project include a systematic assessment of VTE, i.e. disease status (symptoms, clinical and subclinical aspects) and risk profiles (classic, psychosocial and environmental factors), using a system-oriented approach. VTEval collects three large prospective cohorts of patients with suspected and incident VTE consisting of individuals with a clinical suspicion of acute PE, individuals with a clinical suspicion of acute DVT, and individuals with incidental diagnosis of VTE). The standardized and harmonized data acquisition of the study establishes a sustainable resource for comprehensive research on VTE, thus providing the basis for both short- and long-term analysis.
Interventions
None listed
Sponsors
Maastricht University
Hochschule Fresenius
University of Bonn
Siemens Corporation, Corporate Technology
Bayer
Eurofins
Johannes Gutenberg University Mainz
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥18 years and Informed written consent * Clinical condition: * Cohort 1: Clinical suspicion of acute PE (with or without DVT) * Cohort 2: Clinical suspicion of acute DVT (without symptomatic PE) * Cohort 3: Incidentally diagnosed VTE
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mortality | Baseline | Overall mortality, consisting of: * PE-related death * All other causes of death |
| Symptomatic venous thromboembolism | Assessment at month 3, 6 and 12; year 2-6 (Active follow-up) | Composed by: * PE-related death * Development or recurrence of nonfatal PE * Development or recurrence of DVT |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Use of mechanical ventilation | Baseline | — |
| Admission to Intensive Care Unit (ICU) | Baseline | — |
| Recurrence of acute PE | Baseline | — |
| Cardiac dysfunction or heart failure | Baseline | — |
| Pneumonia | Baseline | — |
| Symptomatic and/or asymptomatic DVT | Baseline | — |
| Major bleeding | Baseline | — |
| Clinically relevant non-major bleedings | Baseline | — |
| Diagnostic of a previously unknown malignancy | Baseline | — |
| Length of hospitalization | Baseline | — |
| Implantation of vena cava filter | Baseline | — |
| Thrombolytic treatment | Baseline | — |
| Interventional treatment | Baseline | — |
| Surgery | Baseline | — |
| Overall mortality | Assessment at month 3/6 and 12; year 2-6 (Active follow-up) | — |
| Hospitalization | Assessment at month 3, 6 and 12; year 2-6 (Active follow-up) | — |
| Development or recurrence of clinical symptomatic PE/DVT | Assessment at month 3, 6 and 12; year 2-6 (Active follow-up) | — |
| Asymptomatic DVT | Assessment at month 3, 6 and 12; year 2-6 (Active follow-up) | — |
| Chronic venous insufficiency (CVI) | Assessment at month 3, 6 and 12; year 2-6 (Active follow-up) | — |
| Post-thrombotic Syndrome (PTS) | Assessment at month 3, 6 and 12; year 2-6 (Active follow-up) | — |
| Development of cardiac dysfunction or heart failure | Assessment at month 3, 6 and 12; year 2-6 (Active follow-up) | — |
| Development of pulmonary hypertension | Assessment at month 3, 6 and 12; year 2-6 (Active follow-up) | — |
| Respiratory dysfunction | Assessment at month 3, 6 and 12; year 2-6 (Active follow-up) | — |
| Net clinical outcome (NCO) | Assessment at month 3, 6 and 12; year 2-6 (Active follow-up) | — |
| O2 home treatment | Assessment at month 3, 6 and 12; year 2-6 (Active follow-up) | — |
| Pulmonary vasoactive drugs | Assessment at month 3, 6 and 12; year 2-6 (Active follow-up) | — |
| Development of Chronic Thromboembolic Pulmonary Hypertension (CTEPH) | Assessment at month 3, 6 and 12; year 2-6 (Active follow-up) | — |
| Length of stay in Hospital due to VTE | Assessment at month 3, 6 and 12; year 2-6 (Active follow-up) | — |
| Major adverse cardiac and cerebrovascular event (MACCE) | Assessment at month 3, 6 and 12; year 2-6 (Active follow-up) | — |
| Cardiovascular event | Assessment at month 3, 6 and 12; year 2-6 (Active follow-up) | — |
| Cerebrovascular event | Assessment at month 3, 6 and 12; year 2-6 (Active follow-up) | — |
| PE-related death | Assessment at month 3, 6 and 12; year 2-6 (Active follow-up) | — |
| Hemodynamic instability | Baseline | Defined as at least one of the following: * Cardiopulmonary resuscitation (CPR) or defibrillation * Cardiogenic shock or need of catecholamine administration * Systolic blood pressure \< 90mm Hg, or a pressure drop by more than 40mm Hg for \>15 min |
Countries
Germany
Contacts
Primary ContactPhilipp S Wild, MD, MSc
Outcome results
None listed