NCT05033314

THromboprophylaxis In Sickle Cell Disease With Central Venous Catheters (THIS)

THromboprophylaxis In Sickle Cell Disease With Central Venous Catheters (THIS): A Pilot Study

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: University Health Network, Toronto · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Sickle Cell Disease
• Central Venous Catheter Thrombosis
• Venous Thromboembolism

Interventions

Type	Name	Description
DRUG	Rivaroxaban 10 MG	Rivaroxaban 10mg PO daily as thromboprophylaxis
DRUG	Placebo	matching placebo daily

Timeline

• Start date: 2022-06-07
• Primary completion: 2024-10-01
• Completion: 2024-10-01
• First posted: 2021-09-02
• Last updated: 2025-03-19

Locations

3 sites across 1 country: Canada