Garfield-VTE Study

Start date:
May 2015

End date:
December 2019

Co-ordinated by:
Thrombosis Research Institute UK

Main trial site:
RIE

Global Anticoagulant Registry in the FIELD observing treatment and outcomes in patients with treated acute Venous Thromboembolic Events in the real world.

Aim

The study objectives are to describe acute, sub-acute and extended duration of anticoagulation management, clinical and economic outcomes in patients with treated acute VTE (DVT and PE) in the real-world setting.

Trial Design

Global, prospective, observational, multi-centre VTE registry to be conducted in sequential cohorts.

In order to observe temporal trends in management of VTE a minimum of 2 cohorts will be recruited. Recruitment into the second (or subsequent cohorts) will commence when recruitment is completed into the first or previous cohort. It is estimated that each cohort will take approximately 9 months to recruit. Potential patients must be assessed for eligibility within 30 days of their acute VTE diagnosis.

Cohort One

5000 consecutive unselected patients treated for acute VTE and followed prospectively for a minimum of 36 months

Cohort Two

A further 5000 consecutive unselected patients treated for acute VTE and followed prospectively for a minimum of 36 months

Eligibility criteria

Inclusion Criteria

1. Written informed consent
2. Age 18 years and over
3. Treated first time or recurrent DVT (lower or upper extremity), PE alone or overlapping DVT and PE confirmed by appropriate diagnostic methods (patients must be assessed for eligibility within 30 days of diagnosis)
4. Patients included with recurrent VTE must have completed treatment for the previous VTE episode

Exclusion Criteria

1. Patients for whom long-term follow up is not envisaged within the enrolling hospital or the associated primary care physician
2. Patients participating in an interventional study that dictates treatments, visit frequency, or diagnostic procedures
3. Patients with only superficial vein thrombosis (SVT)