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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01343680 |
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Date of registration:
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27/04/2011 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Trial of Two Central Venous Catheter (CVC) Flushing Schemes in Pediatric Hematology and Oncology Patients
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Scientific title:
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A Randomized Controlled Crossover Trial of Two Different Central Venous Catheter Flushing Schemes in Pediatric Hematology and Oncology Patients in Alberta, Canada |
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Date of first enrolment:
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April 2011 |
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Target sample size:
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2 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT01343680 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention
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Phase:
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Phase 3
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Countries of recruitment
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Canada
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Contacts
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Name:
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Martin A Campbell, MBBS FRACP |
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Address:
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Telephone:
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Email:
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Affiliation:
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Alberta Children's Hospital |
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Key inclusion & exclusion criteria
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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
Age minimum:
N/A
Age maximum:
17 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Childhood Cancer
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Aplastic Anemia
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Metabolic Disorders
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Intervention(s)
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Drug: Normal saline
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Drug: Heparin
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Primary Outcome(s)
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Occlusion rate
[Time Frame: 6 months]
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Secondary Outcome(s)
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Complication rate
[Time Frame: 6 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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