Validation of a Point-of-care Device Measuring Ferritin With Capillary Blood

Not Applicable

Withdrawn

• Conditions: Anemia, Iron Deficiency; Iron Overload; Iron-deficiency
• Interventions: Diagnostic Test: Point of care ferritin test

• Registration Number: NCT03800446
• Lead Sponsor: McMaster University

Brief Summary

Measurement of iron is important for identifying both low and high iron levels in the body. Measuring a protein in the blood called ferritin is currently the easiest way to determine a patient's iron status. However, the test requires a blood sample that is be sent to the laboratory for measurement, which can cause delays in obtaining the result. The investigators are testing whether a point of care device that measures ferritin levels using a capillary blood sample is accurate compared to current methods of testing. This could allow measurement of ferritin immediately in the clinic with only a drop of blood, and enable treatment decisions based on these results.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2018-12-12
• Study First Submitted QC: 2019-01-09
• Study First Posted: 2019-01-11
• Study Start: 2019-09
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-17
• Last Update Posted: 2019-12-19
• Primary Completion: 2020-04
• Study Completion: 2020-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• able to read and understand English (the consent form is in English)
• attending ambulatory hematology clinic and/or outpatient medical care

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Exclusion Criteria

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Point of care ferritin test	All patients will undergo testing with the study intervention (point of care) and routine testing with serum ferritin (venous blood sample).

Primary Outcome Measures

Name	Time	Method
Point of care ferritin detection accuracy	Within 12 hours of standard testing	The proportion of subjects where the difference between the two different methods is less than 15; this will be measured by calculating the difference between the two results.; The proportion for the absolute difference between the two measurement methods on the same subject that is less than 15 ng/mL will be calculated. Non-inferiority test for one proportion will be performed to examine, if, the proportion is greater than 95%, where the test p value and the one-sided 97.5% confidence interval will be reported.; An interim analysis will be performed after the first 50 subjects are enrolled to test the assumptions made.

Secondary Outcome Measures

Name	Time	Method
Distribution of the differences between ferritin level as measured by the standard test and POC test	Within 12 hours of standard testing	Distribution of the differences between the two measurement methods using the normality test, mean difference and its 95% CI, and outlier detection; other methods may be used as appropriate
Comparison of the differences between ferritin levels as measured by the standard test and POC test in a Repeated Measures Design	Within 12 hours of standard testing	Applies to patients who have multiple measurement points during study follow-up. The differences in ferritin levels between the two methods will be studied using a mixed model to account for the between-subject variation and the within-subject variation. The mean difference and its 95% CI, the Bonferroni-adjusted p-values and the plot of mean vs time will be reported.
Diagnostic accuracy of the new measurement method	Within 12 hours of standard testing	The Receiver Operating Characteristic curves (ROC) analysis will be performed to report the diagnostic accuracy for the new measurement method. The optimal cut-off value and the associated accuracy measures (sensitivity, specificity, predictive values and etc.) will be reported.
Agreement between testing methods in patients who have been assessed at least twice	Within 12 hours of standard testing	Applies only to patients with at least two repeated measures. Agreement between the two measurement methods will be quantified and summarized using probability of agreement.