venous thromboembolism
Conditions
Interventions
None listed
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - At least 18 years old - Unprovoked venous thromboembolism - Objectively comfirmed venous thromboembolism - Treated with an oral anticoagulant for 5-8 months with plans to continue (vitamin K antagonist or new oral anticoagulant) - If taking a vitamin K antagonist; INR target is between 2.0-3.0 - If taking a vitamin K antagonist; must have taken it for the last 3 consecutive weeks (minuimum)
Exclusion criteria
Exclusion criteria: - Recurrent venous thromboembolism during the 5-8 month treatment period prior to study enrolment - Major bleeding event during the 5-8 month treatment period prior to study enrolment - Cancer diagnosis during the 5-8 month treatment period prior to study enrolment - Unable to provide written informed consent - Refusal to provide written informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major bleeding as defined by the International Society of Thrombosis and Haemostasis. Overt bleeding with at least one of the following criteria: • associated with a fall in hemoglobin of 2g/dL or more • leading to a transfusion of 2 or more units of packed red blood cells or whole blood • occurring in a critical site: intracranial, intraspinal, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal • contributing to death | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinically-relevant non-major bleeding events will also be collected. These are defined as overt bleeding episodes not meeting the inclusion for major bleeding but associated with one of the following: • medical intervention • an unscheduled contact with a physician • (temporary) cessation of VKA treatment • associated with discomfort for the patient such as pain, or impairment of activities of daily life | — |
Countries
Netherlands
Outcome results
None listed