None listed
Conditions
Brief summary
This study aims to evaluate the feasibility and safety of normal saline, compared to heparinised saline, for the prevention of occlusions (blockages) in central venous access devices (CVADs) in a paediatric oncology population. Who is it for? You or your child may be eligible to join this study if you/they are aged 0-18 years, have been diagnosed with an oncological or malignant haematological condition, and have a central venous access device (CVAD) in situ. CVADs are flexible tubes inserted in the chest, neck or upper arm veins, which enable the administration of anti-cancer drugs, collection of blood tests, and delivery of supportive therapies. Study details Participants in this study will be randomly allocated (by chance) into one of two groups. Participants in one group will have their CVAD locked with 0.9% Sodium Chloride, whilst participants in the other group will have theirs locked with heparinised saline. Duration of study enrollment will be capped at six weeks. All participants will be monitored throughout their enrolment in the study to determine any CVAD blockages (known as occlusions), or other adverse events such as venous thrombosis and infection. We hope to determine whether a larger efficacy trial of these CVAD locking techniques is feasible and safe.
Interventions
0.9% Sodium Chloride locking (10mL 0.9% Sodium chloride pulsatile flush and catheter lock)
Volume will be determined as per hospital protocol, appropriate to the volume of the catheter, administered intravenously
Current policy is: When CVADs (including PICCs, tunnelled catheters and totally implanted venous port device) are accessed daily, a 10mL pulsatile flush of 0.9% sodium chloride is administered after each use. When CVADs (including PICCs, tunnelled catheters and totally implanted venou
0.9% Sodium Chloride locking (10mL 0.9% Sodium chloride pulsatile flush and catheter lock) Volume will be determined as per hospital protocol, appropriate to the volume of the catheter, administered intravenously Current policy is: When CVADs (including PICCs, tunnelled catheters and totally implanted venous port device) are accessed daily, a 10mL pulsatile flush of 0.9% sodium chloride is administered after each use. When CVADs (including PICCs, tunnelled catheters and totally implanted venous port device) are not likely to be used for > 24 hours and up to 1 week, 1-2mLs (volume of catheter dependent) 10U/mL heparin sodium is instilled in the catheter to ensure patency. This is repeated weekly or after use whichever comes sooner. When totally implanted venous port device will not be used for > 1 week, up to 6-8 weeks, 2 mLs of 100u/mL heparin lock is administered to ensure patency.
Sponsors
Queensland Children's Hopsital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
0 to 18 Years
Healthy volunteers
No
Inclusion criteria
• Ages 0 – 18years • Have a central venous access device in situ; • Diagnosed with an oncological or malignant haematological condition • Informed consent to participate
Exclusion criteria
• End of life pathway • Pre-existing coagulopathic condition not related to current diagnosis or treatment such as (but not limited to): Haemophilia A & B or other factor deficiency; Idiopathic Thrombocytopenic Purpura (ITP); Von Willibrand’s disease • Coagulation disorders related to current diagnosis or treatment e.g. Disseminated Intravascular Coagulopathy (DIC) • Current treatment with PEG-Asparaginase • Allergy to heparin • Admission to Paediatric Intensive Care Unit (PICU) • Admission to regional hospital or alternative healthcare facility • Previous study participation •BMT planned during study period/ or currently in progress .
Outcome results
None listed