GARFIELD-VTE explored acute and long-term management and outcomes in patients with symptomatic DVTs and PEs treated in a real-world setting with standard therapy and new oral anticoagulants (OACs)
GARFIELD-VTE explored acute and long-term management and outcomes in patients with symptomatic DVT and PEs treated in a real world setting with standard therapy and new oral anticoagulants (OACs). It provided patients, physicians and policy makers with unprecedented insights on managing and improvement patient care. For patients with DVT and PE, fast action in the acute phase of treatment, especially rapidly fatal PEs, is vital for preserving life and health. Equally important, the risk of recurrence needs to also be managed. Current treatment regimens in real-life practice seem to be shorter than recommended guidelines. Real – world clinical data is needed to confirm this dynamic and understand why it occurs. The GARFIELD registry was an academic research initiative, led by the TRI and a multi-disciplinary steering committee – and it was supported by an unrestricted research grant from Bayer AG. The Global Anticoagulant Registry in the field of venous thromboembolism events was a perspective, multicentre, international registry of patients with newly diagnosed VTE: Deep Vein Thrombosis (DVT) and / or Pulmonary Embolism (PE). The GARFIELD-VTE registry brings a real-world perspective to the field of venous thrombosis.
Travel Through Our Timeline
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2014
First Patient (FPFV)
2016
First data presented on Methods (LPFV)
10,000 Patients Recruited
Recruitment closed in 26 countries
Phase I On-Site Monitoring Starts
2017
10,000+ 6 months data cut 5,000+ 12 months data cut
Phase II On-site Monitoring Starts
2018
Phase III (Final) On-Site Monitoring Starts
2020
End of registry
Objectives
GARFIELD-VTE is important in bridging the gap between research and clinical practice, serving to increase awareness of the importance of DVT / PE and its treatment.
The objectives are:
To describe the acute, sub-acute and extended duration of anticoagulation management;
To describe the clinical and economic outcomes in patients with treated acute VTE (DVT and PE) in the real-world setting.
Study Design
10,000 newly diagnosed VTE patients in 28 countries comprising 2 sequential cohorts of 5,000 patients
Selection of sites representative of national VTE care settings
Prospective patients enrolled consecutively
Long-term follow-up (minimum of 3 years)
Audit requirements
10% of all CRFs monitored against source documentation
Electronic audit trail for all data modifications
Critical variables subjected to additional audit
Compliant with Declaration of Helsinki
Patient Eligibility
Patient Eligibility
Inclusion criteria
Patients are ≥18 years
Confirmed diagnosis of VTE (DVT or PE ± DVT)
Assessed for eligibility within 30 days of diagnosis
Treated for first or recurrent episode of VTE
Patients with recurrent VTE must have completed treatment for previous VTE episodes
Exclusion criteria
Patients for whom long-term follow up is not envisaged within the enrolling hospital or the associated primary care physicians
Patients participating in the interventional study that dictates treatments, visit frequency, or diagnostic procedure
Patients with only superficial vein thrombosis (SVT)
End Points
Over the duration of the registry GARFIELD-VTE will:
Obtain clarity on:
The treatment for VTE
VTE recurrence (early & late)
Bleeding complications
All-cause mortality
VTE complications
Additional outcomes include:
Stroke & TIA
Unstable angina, STEMI & NSTEMI
Patient reported outcomes
Health resource consumption
Quality Assurance
GARFIELD-VTE is governed by the highest academic and ethical standards in the generation, dissemination and communication of its research findings.
Audit Requirements:
10% of all electronic case report forms (CRFs) are monitored against source documentation
Electronic audit trail for all data modifications
Critical Variables subjected to an additional audit