Non-invasive Diagnostics of Iron Deficiency in Surgical Patients by Measuring Zinc Protoporphyrin-IX

Completed

• Conditions: Iron-deficiency; Iron Deficiency Anemia; Anemia
• Interventions: Diagnostic Test: Non-invasive analysis of Zinc protoporphyrin

• Registration Number: NCT03071497
• Lead Sponsor: Johann Wolfgang Goethe University Hospital

Brief Summary

* In approx. 40% of the incidences anemia is caused by iron deficiency (= ID). In turn, preoperative iron-deficiency anemia (= IDA) is associated with an increase in morbidity and mortality as well as with the need for a blood transfusion.

* A successful preoperative treatment of IDA via iron supplementation requires a timely screening of iron deficiency, typically done by analyzing specific blood parameters. This however of course requires drawing a blood sample which further reduces the patients' blood volume and is in many cases stated as an inconvenient procedure.

* Measured in blood zinc protoporphyrin-IX (= ZnPP) is an established parameter to detect ID.

* This study aims to evaluate a prototype device detecting ZnPP non-invasively in the intact oral mucosa of surgical patients.

* Results from the non-invasive measurement will be compared to reference measurements of ZnPP from residual blood samples (HPLC analysis) as well as to other parameters including Hb level and iron profile (MCH \[= mean corpuscular hemoglobin\], MCV \[= mean corpuscular volume\], ferritin, transferrin, transferrin saturation, soluble transferrin receptor, CRP).

Detailed Description

The non-invasive measurements will be performed using a prototype device based on fluorescence spectroscopical techniques. In brief, light (restricted wavelengths: 407 / 425nm) will be used to excite ZnPP molecules within the blood of the oral mucosa by means of an optical fibre prob. The outgoing fluorescence emission of the excited molecules will be analyzed using a spectrometer and converted to a ZnPP value \[unit: µmol/mol heme\] using mathematical transformations as well as spectral fitting.

This study compares the diagnostic performance of iron deficiency based on non-invasive measurements of Zinc protoporphyrin with results based on standard laboratory procedure (i.e. ZnPP measured in whole blood sample using HPLC) and blood values assessed during clinical routine, respectively.

If results of non-invasive and reference measurement techniques yield coinciding results, the non-invasive method could provide an improved mean to detect iron deficiency and thereby to improve treatment of patients suffering from iron deficiency anemia.

Study Timeline

• Study First Submitted: 2017-02-25
• Study First Submitted QC: 2017-03-01
• Study Start: 2017-03-03
• Study First Posted: 2017-03-07
• Primary Completion: 2018-05-01
• Study Completion: 2018-05-01
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-14
• Last Update Posted: 2018-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Age > 18 years

Exclusion Criteria

• Patients who received a blood transfusion less than 8 weeks before examination
• Pregnancy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study Group	Non-invasive analysis of Zinc protoporphyrin	Detecting iron deficiency using various methods. All patients that fit the inclusion criteria and are willing to participate in the study will be included in this group.

Primary Outcome Measures

Name	Time	Method
Zinc protoporphyrin blood concentration (non-invasive measurement)	Baseline	Using the prototype device Zinc protoporphyrin blood concentration \[unit: µmol/mol heme\] will be measured non-invasively in the oral mucosa.; Concentrations will be compared (Spearman's Rho, sensitivity, specificity) with Zinc protoporphyrin measurements of whole blood samples (see outcome 2 and 3).

Secondary Outcome Measures

Name	Time	Method
Zinc protoporphyrin blood concentration (spectroscopic measurement)	Baseline	Using fluorescence spectroscopic methods Zinc protoporphyrin blood concentration \[unit: µmol/mol heme\] will be measured in whole blood samples.
Zinc protoporphyrin blood concentration (HPLC reference measurement)	Baseline	Using HPLC, the analytical reference method, Zinc protoporphyrin blood concentration \[unit: µmol/mol heme\] will be measured in whole blood samples.

Trial Locations

Locations (1)

Johann Wolfgang Goethe University Hospital; 🇩🇪 Frankfurt am Main, Hesse, Germany