THromboprophylaxis In Sickle Cell Disease With Central Venous Catheters (THIS)
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.
Timeline
- Start
- 2022-06-07
- Primary completion
- 2024-10-01
- Completion
- 2024-10-01
Outcome
Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)
Stopped (Enrollment): “Study terminated due to slow recruitment.”
paper The primary outcomes pertain to the feasibility of a full trial and include numbers of eligible and recruited participants. PMID 38171625 ↗
paper THIS pilot trial was closed prematurely due to slow recruitment, lack of funding, and non-feasibility of the complete trial. PMID 41249873 ↗
Publications
- Abdulrehman J, Forte S, Tomlinson G, Solh Z, Bolster L, Sun HL, Kuo KHM. Challenges in Trials in Sickle Cell Disease: Thromboprophylaxis in Sickle Cell Disease With Central Venous Catheters (THIS) Pilot Study. J Clin Apher. 2025 Dec;40(6):e70072. doi: 10.1002/jca.70072.
- Abdulrehman J, Forte S, Tomlinson G, Solh Z, Bolster L, Sun HL, Bartolucci P, Kuo KHM. THromboprophylaxis In Sickle Cell Disease with central venous catheters (THIS): an internal pilot randomised controlled trial protocol. BMJ Open. 2024 Jan 3;14(1):e079363. doi: 10.1136/bmjopen-2023-079363.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Rivaroxaban | Other / unclassified | 10 mg | Oral |