Global Anticoagulant Registry in the FIELD- Venous Thromboembolic Events
- Conditions
- Venous ThromboembolismDeep Vein ThrombosisPulmonary Embolism
- Registration Number
- NCT02155491
- Lead Sponsor
- Thrombosis Research Institute
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10679
- 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
- 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)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Anticoagulation therapy persistence 36 months Estimation of Anticoagulation therapy will be compared to actual total time Anticoagulation therapy was used by patients.
Hospitalization 36 months Measured by number of occurrences.
All cause of mortality 36 months Causes of death: PE, stroke, cardiac, cancer-related, other...
IVC filter placement 36 months Measured by number of occurrences.
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)
Post Thrombotic Syndrome 36 months Measured by number of occurrences and severity.
Chronic thromboembolic pulmonary hypertension 36 months Measured by number of occurrences and severity.
Other urgent interventions for VTE 36 months Measured by number of occurrences.
Bleeding events 36 months Frequency, location, severity (classified as major or non-major)
- Secondary Outcome Measures
Name Time Method Myocardial Infarction 36 months Measured by number of occurrences of both ST-Elevated Myocardial Infarction and Non-ST Elevated Myocardial Infarction (STEMI/NSTEMI).
Quality of life and patient treatment satisfaction over a three year period 36 months Measured by Questionnaire.
Unstable angina 36 months Measured by number of occurrences.
Stroke 36 months Ischemic stroke, hemorrhagic stroke
Trans Ischemic Attack (TIA) 36 months Measured by number of occurrences.
Trial Locations
- Locations (1)
Dr Terence Hart
🇺🇸Muscle Shoals, Alabama, United States