A Randomized Controlled Crossover Trial of Two Different Central Venous Catheter Flushing Schemes in Pediatric Hematology and Oncology Patients in Alberta, Canada
Overview
- Phase
- Phase 3
- Intervention
- Heparin
- Conditions
- Childhood Cancer
- Sponsor
- Alberta Children's Hospital
- Enrollment
- 2
- Locations
- 2
- Primary Endpoint
- Occlusion rate
- Status
- Terminated
- Last Updated
- 13 years ago
Overview
Brief Summary
The purpose of this study is to determine whether flushing Central Venous Catheters (CVCs) with Normal saline once per week is not inferior to flushing with 10U/ml heparin 3 times per week, in preventing CVC occlusions.
Detailed Description
Tunneled central venous catheters (CVCs) are now used routinely in pediatric hematology and oncology patients. Flushing with heparin solution is routinely recommended to prevent occlusion of long term CVCs, although the concentration of heparin used, and frequency of its use varies between centres. Once weekly Normal saline is also used successfully in some pediatric enters. There is little evidence to support one method over the other. The investigators have designed a randomised crossover trial to directly compare once weekly Normal saline flushing with 3 times per week 10U/ml heparin flushing, to determine whether Normal saline is not inferior to heparin.
Investigators
Martin Campbell
Paediatric Oncologist
Alberta Children's Hospital
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •Thrombophilia (e.g. Factor V Leiden mutation, antiphospholipid syndrome) or previous thrombosis requiring anticoagulation (e.g. enoxaparin, unfractionated heparin)
- •Bleeding disorder (e.g. von Willebrand's disease, hemophilia)
- •Previous CVC that was removed due to any complication
Arms & Interventions
10U/l heparin
Intervention: Heparin
normal saline
Intervention: Normal saline
Outcomes
Primary Outcomes
Occlusion rate
Time Frame: 6 months
Secondary Outcomes
- Complication rate(6 months)