Clinical trial NCT03071497: Non-invasive Diagnostics of Iron Deficiency in Surgical Patients by Measuring Zinc Protoporphyrin-IX
Official title: Non-invasive Diagnostics of Iron Deficiency in Surgical Patients by Measuring Zinc Protoporphyrin-IX
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Iron-deficiency
Anemia
Iron Deficiency Anemia
Keywords: Iron-deficiency
Anemia
Iron-deficiency Anemia
Zinc protoporphyrin
Lead sponsor: Johann Wolfgang Goethe University Hospital
Sponsor class: OTHER
Collaborators: name: Ludwig-Maximilians - University of Munich
First posted: 2017-03-07
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients preoperatively screened for anemia in the anemia walk-in clinic of the University Hospital Frankfurt that fit the inclusion criteria will be asked to participate in the study.

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.

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years

Exclusion Criteria:

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

Primary outcomes:
measure: Zinc protoporphyrin blood concentration (non-invasive measurement)
timeFrame: Baseline
Secondary outcomes:
measure: Zinc protoporphyrin blood concentration (HPLC reference measurement)
timeFrame: Baseline
measure: Zinc protoporphyrin blood concentration (spectroscopic measurement)
timeFrame: Baseline
Other outcomes:
measure: Hemoglobin
timeFrame: Baseline
measure: MCH
timeFrame: Baseline
measure: MCV
timeFrame: Baseline
measure: Ferritin
timeFrame: Baseline
measure: CRP
timeFrame: Baseline
measure: Transferrin saturation
timeFrame: Baseline
measure: Soluble transferrin receptor
timeFrame: Baseline
Locations:
city: Frankfurt am Main
country: Germany
facility: Johann Wolfgang Goethe University Hospital
state: Hesse
Study officials:
affiliation: Johann Wolfgang Goethe University Hospital
name: Patrick Meybohm, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: