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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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16 December 2017 |
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Main ID: |
NCT03112421 |
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Date of registration:
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03/04/2017 |
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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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Method and Sample Comparison Study Minicare BNP - COMP-BNP-CE03-AN2016
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Scientific title:
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Method and Sample Comparison Study of Minicare BNP at a Central Laboratory |
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Date of first enrolment:
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February 27, 2017 |
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Target sample size:
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296 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03112421 |
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Study type:
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Observational |
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Study design:
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Phase:
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N/A
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Countries of recruitment
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Netherlands
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Key inclusion & exclusion criteria
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Left over blood samples from eligible patients with BNP requests, available at the test
site CENTRAL LABORATORY will be selected for this study.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Heart Failure
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Primary Outcome(s)
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To investigate the bias between the Philips Minicare BNP test with the Centaur BNP test of the measurement procedures.BNP level measured in human blood samples (EDTA venous whole blood and/or EDTA plasma) will be assessed.
[Time Frame: May 2017]
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To compare BNP measurements obtained using Minicare System for EDTA whole blood and EDTA plasma samples.
[Time Frame: May 2017]
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Secondary Outcome(s)
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Percentage of agreement samples
[Time Frame: May 2017]
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Evaluate performance of the SmearSafe Blood Dispenser (transfer device), for transferring whole blood from the blood tube directly to the Minicare BNP cartridge.
[Time Frame: May 2017]
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Percentage of agreement systems
[Time Frame: May 2017]
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Secondary ID(s)
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HHDx-07952
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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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