Global Anticoagulant Registry in the FIELD- Venous Thromboembolic Events

Global Anticoagulant Registry in the Field Observing Treatment and Outcomes in Patients With Treated Acute Venous Thromboembolic Events in the Real World

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02155491

Acronym

GARFIELD-VTE

Enrollment

10679

Registered

2014-06-04

Start date

2014-07-07

Completion date

2020-09-30

Last updated

2021-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Deep Vein Thrombosis, Pulmonary Embolism, Venous Thromboembolism

Keywords

venous, thromboembolism, embolism, DVT, Pulmonary Embolism, thrombosis

Brief summary

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

Detailed 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 99 Years

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)

Design outcomes

Primary

Measure	Time frame	Description
Post Thrombotic Syndrome	36 months	Measured by number of occurrences and severity.
All cause of mortality	36 months	Causes of death: PE, stroke, cardiac, cancer-related, other...
International Normalized Ratio (INR) Values in Patients treated with Vitamin K Antagonists	36 months	Will be assessed by frequency of INR monitoring, and number of INR readings taken before patient achieved optimum range.
Rate of recurrent symptomatic VTE (DVT and fatal or non-fatal PE)	36 months	Rate of recurrent symptomatic VTE (DVT and fatal or non-fatal PE)
Bleeding events	36 months	Frequency, location, severity (classified as major or non-major)
Hospitalization	36 months	Measured by number of occurrences.
Chronic thromboembolic pulmonary hypertension	36 months	Measured by number of occurrences and severity.
IVC filter placement	36 months	Measured by number of occurrences.
Other urgent interventions for VTE	36 months	Measured by number of occurrences.
Anticoagulation therapy persistence	36 months	Estimation of Anticoagulation therapy will be compared to actual total time Anticoagulation therapy was used by patients.

Secondary

Measure	Time frame	Description
Trans Ischemic Attack (TIA)	36 months	Measured by number of occurrences.
Myocardial Infarction	36 months	Measured by number of occurrences of both ST-Elevated Myocardial Infarction and Non-ST Elevated Myocardial Infarction (STEMI/NSTEMI).
Unstable angina	36 months	Measured by number of occurrences.
Quality of life and patient treatment satisfaction over a three year period	36 months	Measured by Questionnaire.
Stroke	36 months	Ischemic stroke, hemorrhagic stroke

Countries

United States

Outcome results