Summary
Across Australia every year, children undergoing treatment for cancer experience more than 250 blood stream infections, 70 deeo vein thromboses, and 300 blockages - all caused from the 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 do more to prevent harm.
When teh CVAD is not in use, it is locked with fluid. This fluid lock is an opportunity to prevent CVAD-associated complications. Therefore, the aim of this study is to compare the safety and effectiveness of three different locking solutions: KiteLock, heparinised saline and normal saline.
Participants will be randomly allocated to receive either the normal saline, heparinised saline, or KiteLock administered into the lumen of the CVAD.
The solution will be administered at a frequency based on clinical requirement plus during routine management procedures, with a maximum of one dose per 24 hours. This will continue until the device is removed or the participant withdraws from the study, for up to a maximum of 3 months post-enrolment.
Throughout this study period, participants may be assessed by their treating clinicians for bloodstream infections using blood cultures, for CVAD-associated thrombosis (i.e. blood clots) with ultrasound or venography, for blockages of the CVAD with a test of injection and/or aspiration catheter occlusion, and for CVAD failure requiring removal. Participants will also be monitored for any adverse events, with a research nurse contacting them twice weekly across the study period. A questionnaire assessing health-related quality of life will be given to participants at the trial commencement and completion. Participants will additionally be followed up at 1 and 5 years after study completion (using medical records only).
It is hoped that this study may help to identify the locking solution with the least complications and adverse effects, in order to prevent harm in children with a CVAD undergoing treatment for cancer.