Brief Title
Trial of Two Central Venous Catheter (CVC) Flushing Schemes in Pediatric Hematology and Oncology Patients
Official Title
A Randomized Controlled Crossover Trial of Two Different Central Venous Catheter Flushing Schemes in Pediatric Hematology and Oncology Patients in Alberta, Canada
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.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Occlusion rate
Secondary Outcome
Complication rate
Condition
Childhood Cancer
Intervention
Heparin
Study Arms / Comparison Groups
10U/l heparin
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
2
Start Date
April 2011
Completion Date
May 2012
Primary Completion Date
May 2012
Eligibility Criteria
Inclusion Criteria
- Diagnosis of any malignant or nonmalignant disease that requires a single lumen
Broviac or double lumen Hickman-type CVC for the purpose of chemotherapy, blood
product support or hematopoietic stem cell transplantation.
- CVC is planned to remain in situ for 6 months from study entry
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
Gender
All
Ages
N/A - 17 Years
Accepts Healthy Volunteers
No
Contacts
Martin A Campbell, MBBS FRACP, ,
Location Countries
Canada
Location Countries
Canada
Administrative Informations
NCT ID
NCT01343680
Organization ID
ACH23736
Responsible Party
Principal Investigator
Study Sponsor
Alberta Children's Hospital
Collaborators
Stollery Children's Hospital
Study Sponsor
Martin A Campbell, MBBS FRACP, Principal Investigator, Alberta Children's Hospital
Verification Date
May 2012