Preventing adverse events during paediatric cancer treatment: A multi-site hybrid randomised controlled trial of catheter lock solutions (The CLOCK trial)

Reducing the rate of infections and blood clots in children being treated for cancer, to improve their journey through cancer treatment.

Background

Across Australia every year, children undergoing treatment for cancer experience more than 250 bloodstream infections, 70 deep vein thromboses and 300 blockages - all caused from their central line. This central venous access device (CVAD) is vital as it administers treatments such as chemotherapy drugs and supportive therapies including blood transfusions and antibiotics, however we need to prevent harm. When the CVAD is not in use, it is locked it with fluid. This fluid lock is an opportunity to prevent CVAD-associated complications.

In this world-first trial, the research team will evaluate the effectiveness of the CVAD lock solution compared to usual care to reduce infections, thromboses and blockages for children being treated for cancer. This is a Type-1 Hybrid effectiveness-implementation two-arm, superiority, effectiveness RCT which will compare the clinical-effectiveness of routine CVAD lock solutions with T-EDTA in comparison to normal or heparinised saline locks to prevent CVAD-associated complications (CABSI, thromboses, occlusions). Simultaneously, a mixed-methods implementation study will assess the acceptability, costs and implementation challenges of alternative CVAD lock solutions in paediatric cancer care, to prepare for translation of the intervention to practice. A 3-year recruitment period will occur across metropolitan and regional paediatric cancer care networks in Queensland, Victoria, New South Wales and New Zealand.