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

Iron-deficiency Clinical Trial

— FerPOC  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03800446
• Other study ID #: Ferritin POC
• Status: Withdrawn
• Phase: N/A
• Start date: September 2019
• Est. completion date: June 2020

Study information

• Verified date: December 2019
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2020
• Est. primary completion date: April 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• able to read and understand English (the consent form is in English)

• attending ambulatory hematology clinic and/or outpatient medical care

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Anemia, Iron Deficiency
• Anemia, Iron-Deficiency
• Iron Overload
• Iron-deficiency

Intervention

Diagnostic Test:
• Point of care ferritin test
Point of care test that uses capillary blood sample from finger to determine ferritin level

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
McMaster University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Point of care ferritin detection accuracy	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.	Within 12 hours of standard testing
Secondary	Distribution of the differences between ferritin level as measured by the standard test and POC test	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	Within 12 hours of standard testing
Secondary	Comparison of the differences between ferritin levels as measured by the standard test and POC test in a Repeated Measures Design	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.	Within 12 hours of standard testing
Secondary	Agreement between testing methods in patients who have been assessed at least twice	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.	Within 12 hours of standard testing
Secondary	Diagnostic accuracy of the new measurement method	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.	Within 12 hours of standard testing