Study Stopped
Poor patient accrual
Trial of Two Central Venous Catheter (CVC) Flushing Schemes in Pediatric Hematology and Oncology Patients
A Randomized Controlled Crossover Trial of Two Different Central Venous Catheter Flushing Schemes in Pediatric Hematology and Oncology Patients in Alberta, Canada
1 other identifier
interventional
2
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Apr 2011
Shorter than P25 for phase_3
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2011
CompletedFirst Submitted
Initial submission to the registry
April 27, 2011
CompletedFirst Posted
Study publicly available on registry
April 28, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedMay 30, 2012
May 1, 2012
1.1 years
April 27, 2011
May 29, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Occlusion rate
6 months
Secondary Outcomes (1)
Complication rate
6 months
Study Arms (2)
10U/l heparin
ACTIVE COMPARATORnormal saline
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alberta Children's Hospitallead
- Stollery Children's Hospitalcollaborator
Study Sites (2)
Alberta Children's Hospital
Calgary, Alberta, T3B6A8, Canada
Stollery Children's Hospital
Edmonton, Alberta, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Martin A Campbell, MBBS FRACP
Alberta Children's Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Paediatric Oncologist
Study Record Dates
First Submitted
April 27, 2011
First Posted
April 28, 2011
Study Start
April 1, 2011
Primary Completion
May 1, 2012
Study Completion
May 1, 2012
Last Updated
May 30, 2012
Record last verified: 2012-05