A Pilot Study in Cancer Patients With Central Venous Catheter Associated Deep Vein Thrombosis in the Upper Extremity Treated With Rivaroxaban (Catheter 2)
This will be a prospective cohort study of patients who present with an acute upper limb
thrombosis in the setting of a central venous catheter. The total study duration will be 12
weeks, with one follow up telephone visit at 6 months. All patients will be treated with
rivaroxaban at a dose of 15 mg orally twice daily for three weeks, followed by 20 mg daily.
Anticoagulation will continue for three months regardless of the length of time the catheter
is in place. Continuation of anticoagulation beyond this time period is at the discretion of
Strengths of this study include its prospective cohort format, and access to a large
oncologic population through the London Regional Cancer Program and other corresponding
centres. In addition, The Catheter Study looking at CVC survival and safety in patients with
cancer diagnosed with UEDVT and treated with a bridging protocol of warfarin/dalteparin was
organized primarily through the LHSc and results therein could be directly compared to the
results from this study given the similar patient population.
Limitations of this study include the small sample size and the fact that there is no LMWH
monotherapy comparison group. In addition, this will be an open study with no blinding,
given the nature of line survival. There is also the chance that a proportion of patients
will have their catheters removed for other reasons, such as finishing treatment or personal
preference, which could affect the validity of survival results.
This design was selected given the small number of patients presenting with this diagnosis
each year at our centre, which would present difficulty in accruing enough patients for
several comparisons group. Results will be compared to the Catheter Study and previous
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Proportion of central line failure, defined as infusion failure that does not respond to 2mg tPA.
The primary endpoint of the study will be proportion of central line failure, defined as infusion failure that does not respond to 2mg tPA, within the 3 months of study follow-up.
Dr. Michael J. Kovacs, MD, FRCPC
London Health Sciences Centre
Canada: Ethics Review Committee