Development of a Risk Stratification Score for Recurrent Venous Thromboembolism and Treatment-related Clinically Relevant Bleeding in Patients With Cancer-associated Thrombosis

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorOttawa Hospital Research Institute

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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

Time frame
6 months

Secondary outcomes

1

Overall mortality

Post-enrollment follow-up visits will include documentation of death if occuring at any time during the 6 month follow up period

Time frame
6 months
2

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.

Time frame
6 months

Other outcomes

Sponsors and contacts

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Ottawa Hospital Research Institute

Lead sponsor

Canadian Institutes of Health Research (CIHR)

Collaborator