GARFIELD-VTE
Research type
Research Study
Full title
Global Anticoagulant Registry in the FIELD observing treatment and outcomes in patients with treated acute Venous Thromboembolic Events in the real world
IRAS ID
155886
Contact name
Peter MacCallum
Contact email
Sponsor organisation
Thrombosis Research Institute
Clinicaltrials.gov Identifier
NCT02155491, ClinicalTrials.gov Identifier (NCT number); 2013-004758-55, European Clinical Trials Database (EudraCT) number
Research summary
Venous thromboembolism (VTE) is an important global patient safety issue. It is a common and increasing cause of morbidity and mortality with early and long-term management required to prevent acute and long-term chronic complications, such as onset of pulmonary embolism (PE) in patients presenting with deep vein thrombosis (DVT), recurrent VTE, post thrombotic syndrome (PTS) and chronic thromboembolic pulmonary hypertension (CTEPH).
In consideration of the changing clinical landscape with the introduction of new oral anticoagulants, there is a definite need to observe the developments related to managing VTE around the world and gather data in order to understand the quality of treatment for patients and its impact on clinical outcomes.
GARFIELD-VTE is 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.REC name
London - City & East Research Ethics Committee
REC reference
14/LO/1350
Date of REC Opinion
21 Jul 2014
REC opinion
Favourable Opinion