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

NCT03800446 | Withdrawn

• 1 other identifier: Ferritin POC
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Anemia, Iron Deficiency; Iron Overload; Iron-deficiency

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Distribution of the differences between ferritin level as measured by the standard test and POC test

  Within 12 hours of standard testing

• 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

• Agreement between testing methods in patients who have been assessed at least twice

  Within 12 hours of standard testing

• Diagnostic accuracy of the new measurement method

  Within 12 hours of standard testing

Study Arms (1)

Intervention

OTHER

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

Diagnostic Test: Point of care ferritin test

Interventions

Point of care ferritin test DIAGNOSTIC_TEST

Point of care test that uses capillary blood sample from finger to determine ferritin level

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• McMaster University: lead

MeSH Terms

Conditions

Anemia, Iron-Deficiency; Iron Overload

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor; Department of Medicine, Director Operations; Hamilton Regional Laboratory Medicine Program

Model Details: Prospective cohort diagnostic study design

Study Record Dates

• First Submitted: December 12, 2018
• First Posted: January 11, 2019
• Study Start: September 1, 2019
• Primary Completion: April 1, 2020
• Study Completion: June 1, 2020
• Last Updated: December 19, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share