Cancer Clinical Trial
Official title:
A Pilot Study Assessing the Feasibility of a Randomized Controlled Trial Investigating Primary Thromboprophylaxis With Rivaroxaban in Patients With Malignancy and Central Venous Catheters
Purpose of Pilot Trial To determine the feasibility of conducting a multicentre randomized
open label controlled trial evaluating the use of prophylactic dose rivaroxaban to prevent
central venous catheter (CVC) associated venous thromboembolism(VTE) among cancer patients.
Hypothesis: treatment with low dose rivaroxaban (10mg) will reduce the incidence of upper
extremity venous thrombosis in a high risk population with cancer and CVC.
Design:
This is a pilot interventional study to be conducted at 3 Canadian Centres. The Ottawa
Hospital, QEII Health Science Centre and University of Alberta Hospital.
It is an open label randomized controlled trial.
Consenting participants, meeting eligibility criteria will be randomized at the time of
enrollment to one of two groups.
Rivaroxaban 10mg po daily x 90 (+/- 3 ) days OR Standard of Care
Participants in the treatment arm will have study drug dispensed at Day 1 and take medication
for 90 days. Follow up visits (in person or phone) will occur at Day 30 (+/- 3 days) and Day
90 (+/- 3 days) month and 3 months post enrollment. Overall, participants will be followed
for 3 months. Adverse events will be collected for the first 90 days.
Outcomes The primary feasibility outcome for the pilot study is the number of participants
recruited per centre per month. We will obtain baseline details of the patient's type,
location and treatment of cancer, comorbidities and medications. Secondary feasibility
outcomes of the pilot study will include, consent rates, loss to follow up, adherence to
therapy defining 80% or greater medication taken as having good adherence to study drug,
proportion of screened patients who meet eligibility criteria.
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