About this trial
The objective of this study is to prospectively develop a risk assessment model (RAM) that accurately identifies anticoagulated cancer-associated thrombosis (CAT) patients at low- and high-risk of recurrent venous thromboembolism (VTE) and clinically relevant bleeding within 6 months following the CAT diagnosis and to create a biobank of plasma and whole blood samples for further translational research in cancer genetics and hemostasis.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Objectively documented distal and/or proximal DVT of the limb (upper or lower extremity) and/or PE, splanchnic vein thrombosis and/or cerebral sinus vein thrombosis in presence of active cancer of all types
Intended treatment of CAT for at least 6 months with parenteral or oral anticoagulants at therapeutic dosing.
Estimated life expectancy > 6 months
Willingness to give an informed consent
Disqualifiers
Unusual site CAT (gonadal vein thrombosis, ovarian vein thrombosis, retinal vein thrombosis)
Superficial vein thrombosis
Refusal of informed consent > 72 hrs of anticoagulants
Age < 18 years old
Trial population
Patients with Cancer Associated Thrombosis receiving anticoagulation treatment with a follow-up of 6 months
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Recurrent VTE
The primary outcome of the study will include objectively confirmed recurrent VTE (distal and/or proximal deep vein thrombosis (DVT) and/or pulmonary embolism (PE) and/or splanchnic vein thrombosis and/or cerebral venous sinus thrombosis
Secondary outcomes
Overall mortality
Post-enrollment follow-up visits will include documentation of death if occuring at any time during the 6 month follow up period
Clinically relevant bleeding
Post-enrollment follow-up visits will include assessment and documentation of any major and CRNMB and bleeding risk factors at any time during the 6 month follow up period.
Sponsors and contacts
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Ottawa Hospital Research Institute
Lead sponsor
Canadian Institutes of Health Research (CIHR)
Collaborator