About GARFIELD-VTE

Global Information

Recruitment – complete
Total Patients Enrolled – 10,878

  • Cohort 1 – 5025
  • Cohort 2 – 5853

View global reports here

About Garfield-VTE

GARFIELD-VTE exploring 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 will provide 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 is an academic research initiative, led by the TRI and a multi-disciplinary steering committee – and it is supported by an unrestricted research grant from Bayer AG. The Global Anticoagulant Registry in the field of venous thromboembolism events is a perspective, multicentre, international registry of patients with newly diagnosed VTE: Deep Vein Thrombosis (DVT) and / or Pulmonary Embolism (PE). The GARFIELD-VTE registry will bring 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
  • Compliant with Declaration of Helsinki

Global Status

Read more
Total patients 10,878
Recruitment Recruitment closed
Follow-up Follow-up ongoing
Study end: 2020

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Contact Us

To find out more about GARFIELD-VTE, please contact the Thrombosis Research Institute

E: garfield@tri-london.ac.uk
T: 0203 198 9947