Research Question: In adult SCD patients with CVC, is it feasible and safe to conduct an adequately powered RCT to evaluate the use of rivaroxaban as thromboprophylaxis in this population? Study Design: The study is a vanguard pilot double blind multi-centre randomized controlled trial. Participants with SCD and CVC will be randomized to either rivaroxaban 10mg PO daily or placebo for the duration of CVC in situ or for up to one year, whichever is less. After screening (day -7 to day -1), patients will be followed at day 1, months 3 (+/- 15 days), 6 (+/- 15 days), 9 (+/- 15 days), and 12 (+/- 15 days). Study Objectives: The primary objective is to estimate the proportion of eligible patients who will enroll into a trial of thromboprophylaxis. Secondary objectives include (a) document indications for central venous catheter (CVC), (b) summarize duration of CVC insertion prior to enrollment, (c) estimate adherence to the study drug, (d) estimate proportions of participants being compliant with study procedures, and lost to follow up. Exploratory objectives will assess thrombotic, bleeding, and quality of life outcomes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
4
Rivaroxaban 10mg PO daily as thromboprophylaxis
matching placebo daily
University of Alberta Hospital
Edmonton, Alberta, Canada
London Health Sciences Center
London, Ontario, Canada
Toronto General Hospital
Toronto, Ontario, Canada
The proportion of eligible patients who will enroll into a trial of thromboprophylaxis
Time frame: 1 year
Document indications for central venous catheter (CVC)
Time frame: 1 year
Summarize duration of CVC insertion prior to enrollment
Time frame: 1 year
Estimate adherence to the study drug
1. Adherence: percentage of administered drugs not returned (by pill counting); 2. Compliance: defined as percentage adherence \>80%.
Time frame: 1 year
Estimate participants compliance with study procedures, and lost to follow up
Defined as proportion of participant lost to follow up or withdrawn from the study prior to completion of 6 months of treatment
Time frame: 1 year
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