THromboprophylaxis In Sickle Cell Disease With Central Venous Catheters (THIS)
Reason given: Study terminated due to slow recruitment.
Key facts
- Where
- Edmonton, London, and Toronto, CanadaSee the 3 sites
- Phase
- Phase 3
Where in Canada
- University of Alberta HospitalEdmonton, CanadaNo longer taking part
- London Health Sciences CenterLondon, CanadaNo longer taking part
- Toronto General HospitalToronto, CanadaNo longer taking part
Trial details
- Who runs it
- University Health Network, Toronto
- Trial code
- NCT05033314
- Record updated
- 19 March 2025
- Original description
Research Question:Read full original descriptionShow less
THromboprophylaxis In Sickle Cell Disease With Central Venous Catheters (THIS): A Pilot Study
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.
Inclusion: Adult (age 18 or older); Documented SCD; New or pre-existing CVC planned for long term use (at least 6 months); Able to provide written consent.
Exclusion: Previous VTE within the past 3 months; On dual antiplatelet therapy, or high dose single agent aspirin > 325mg/day; On combined P-glycoprotein and strong cytochrome P450 3A4 inhibitors (including but not limited to ketoconazole and protease inhibitors); Contra-indication to prophylactic dose anticoagulation or active bleeding at discretion of treating physician; Acute hepatitis or chronic active hepatitis; Active cancer or treatment for cancer excluding basal cell carcinoma; Known allergy to study drug; Significant medical condition that confers an unacceptable risk to participating in the study, and/or that could confound the interpretation of the study data; Creatinine clearance <30mL/min (as calculated by Cockcroft-Gault equation[67]); Platelet count < 50 x109/L; Already on anticoagulation (prophylactic or therapeutic dose) for an indication other than CVC thromboprophylaxis; Pregnant, within 6 weeks post-partum, or active breast feeding; Cirrhosis with Child-Pugh score B or C; Weight <40kg; Uncontrolled HTN (systolic blood pressure > 170mmhg, or diastolic blood pressure> 100mmhg) despite antihypertensive treatment; On palliative care; On combined P-glycoprotein and strong cytochrome P450 3A4 inducers (including but not limited to rifampin, phenytoin, phenobarbital, carbamazepine, and st. john's wort); Strong indication for thromboprophylaxis at discretion of treating physician.