THromboprophylaxis In Sickle Cell Disease with central venous catheters (THIS): an internal pilot randomised...

Area of Science:

• Hematology
• Pharmacology
• Clinical Trials

Background:

• Sickle cell disease (SCD) patients with central venous catheters (CVC) face a high risk of venous thromboembolism (VTE).
• Limited data exist on anticoagulation for VTE prophylaxis in this population, creating clinical equipoise.
• Rivaroxaban, a direct oral anticoagulant, shows promise for VTE prophylaxis in other patient groups.

Purpose of the Study:

• To evaluate the feasibility and safety of conducting a large-scale randomized controlled trial (RCT) for VTE thromboprophylaxis in SCD patients with CVC.
• To assess the potential role of prophylactic rivaroxaban in this high-risk demographic.

Main Methods:

• A multicenter, double-blinded, randomized controlled pilot trial (THromboprophylaxis In Sickle Cell Disease pilot trial).
• Fifty adult patients with SCD and CVC randomized to receive rivaroxaban (10 mg daily) or placebo.
• Follow-up every 3 months for up to 1 year, monitoring feasibility, VTE incidence, bleeding complications, and quality of life.

Main Results:

• Primary outcomes focus on the feasibility of recruitment and eligibility for a full-scale RCT.
• Exploratory outcomes include the incidence of VTE and bleeding events.
• Quality of life will also be assessed.

Conclusions:

• This pilot study is crucial for determining the viability of a definitive RCT investigating rivaroxaban for VTE prevention in SCD patients with CVC.
• Results will guide the design and execution of a larger trial, potentially establishing a new standard of care.