Global Anticoagulant Registry in the FIELD- Venous Thromboembolic Events (GARFIELD-VTE)

Thrombosis Research Institute

Status: Completed

Conditions: Pulmonary Embolism; Venous Thromboembolism; Deep Vein Thrombosis

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02155491

TRI08889

Details and patient eligibility

About

The protocol is a large registry to describe acute, sub-acute and extended duration of anticoagulation management, clinical and economic duration of anticoagulation management, clinical and economic outcomes in patients with treated acute VTE (DVT and PE) in the real-world setting.

Main objectives are to clarify the:

• treatment related details for acute VTE (either conventional anticoagulation therapy, treatment with a direct oral anti-coagulant or other modalities of treatment)
• Rate of early and late symptomatic VTE recurrence
• Rate and nature of complications of VTE including post thrombotic syndrome and chronic thromboembolic pulmonary hypertension
• Rate of bleeding complications
• Rate of all-cause mortality at six months

Full description

Other objectives are to clarify the additional outcomes of:

• Stroke (Measured by number of incidences)
• Transient Ischemic Attack (TIA) (Measured by number on incidences)
• ST Elevated Myocardial Infarction (STEMI) (Measured by number of incidences)
• Non-ST Elevated Myocardial Infraction (NSTEMI) (Measured by number of incidences)
• Unstable Angina (Measured by number of incidences)
• Quality of life and patient reported outcomes and costs associated with the management of VTE.

Enrollment: 10,679 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Written informed consent
• Age 18 years and over
• 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)
• Patients included with recurrent VTE must have completed treatment for the previous VTE episode

Exclusion criteria

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

Trial design

10,679 participants in 2 patient groups

Prospective cohort 1

Description:

In order to observe temporal trends in management of VTE a first cohort of 5000 consecutive unselected patients treated for acute VTE will be recruited. This cohort will take approximately 9 months to recruit. Potential patients must be assessed for eligibility within 30 days of their acute VTE diagnosis. They will be followed prospectively for 36 months.

Prospective cohort 2

Description:

In order to observe temporal trends in management of VTE a second cohort of 5000 consecutive unselected patients treated for acute VTE will be recruited. Recruitment into the second cohort will commence when recruitment is completed in the first cohort. This cohort will take approximately 9 months to recruit. Potential patients must be assessed for eligibility within 30 days of their acute VTE diagnosis. They will be followed prospectively for 36 months.