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

NCT ID: NCT03800446

Last Updated: 2019-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-30

Study Completion Date

2020-06-30

Brief Summary

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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

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Conditions

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Anemia, Iron Deficiency Iron Overload Iron-deficiency

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Prospective cohort diagnostic study design
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Intervention

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

Group Type OTHER

Point of care ferritin test

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Point of care ferritin test

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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McMaster University

OTHER

Sponsor Role lead

Responsible Party

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Michelle Zeller

Assistant Professor; Department of Medicine, Director Operations; Hamilton Regional Laboratory Medicine Program

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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Ferritin POC

Identifier Type: -

Identifier Source: org_study_id