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

Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03071497
• Other study ID #: 468/16
• Status: Completed
• Start date: March 3, 2017
• Est. completion date: May 1, 2018

Study information

• Verified date: July 2018
• Source: Johann Wolfgang Goethe University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: May 1, 2018
• Est. primary completion date: May 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age > 18 years

Exclusion Criteria:

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

• Pregnancy

Related Conditions & MeSH terms

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

Intervention

Diagnostic Test:
• Non-invasive analysis of Zinc protoporphyrin
In patients fitting the inclusion criteria Zinc protoporphyrin will be measured non-invasively as proxy for iron deficiency. Results will be compared to ZnPP reference values measured via HPLC and with spectroscopical measurements performed on whole blood as well as with blood values (HB, MCH, MCV, ferritin, CRP, transferrin saturation, soluble transferrin receptor) assessed during clinical routine.

Locations

Country	Name	City	State
Germany	Johann Wolfgang Goethe University Hospital	Frankfurt am Main	Hesse

Sponsors (2)

Lead Sponsor	Collaborator
Johann Wolfgang Goethe University Hospital	Ludwig-Maximilians - University of Munich

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Hemoglobin	Hemoglobin levels [unit: g/dL] will be assessed from blood samples using standardized laboratory techniques.; Hemoglobin levels will be compared with non-invasive Zinc protoporphyrin measurements (Spearman's Rho, sensitivity, specificity).	Baseline
Other	MCH	MCH (= mean corpuscular hemoglobin) [unit: pg] will be assessed from blood samples using standardized laboratory techniques.; MCH will be compared with non-invasive Zinc protoporphyrin measurements (Spearman's Rho, sensitivity, specificity).	Baseline
Other	MCV	MCV (= mean cell volume) [unit: fL = femtoliter] will be assessed from blood samples using standardized laboratory techniques.; MCV will be compared with non-invasive Zinc protoporphyrin measurements (Spearman's Rho, sensitivity, specificity).	Baseline
Other	Ferritin	Ferritin [unit: µg/L] will be assessed from blood samples using standardized laboratory techniques.; Ferritin levels will be compared with non-invasive Zinc protoporphyrin measurements (Spearman's Rho, sensitivity, specificity).	Baseline
Other	CRP	CRP (= C-reactive protein) [unit: mg/dL] will be assessed from blood samples using standardized laboratory techniques.; CRP will be compared with non-invasive Zinc protoporphyrin measurements (Spearman's Rho, sensitivity, specificity).	Baseline
Other	Transferrin saturation	Transferrin saturation [unit: %] will be assessed from blood samples using standardized laboratory techniques.; Transferrin saturation will be compared with non-invasive Zinc protoporphyrin measurements (Spearman's Rho, sensitivity, specificity).	Baseline
Other	Soluble transferrin receptor	Soluble Transferrin receptor [unit: mg/L] will be assessed from blood samples using standardized laboratory techniques.; Soluble transferrin receptor will be compared with non-invasive Zinc protoporphyrin measurements (Spearman's Rho, sensitivity, specificity).	Baseline
Primary	Zinc protoporphyrin blood concentration (non-invasive measurement)	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).	Baseline
Secondary	Zinc protoporphyrin blood concentration (HPLC reference measurement)	Using HPLC, the analytical reference method, Zinc protoporphyrin blood concentration [unit: µmol/mol heme] will be measured in whole blood samples.	Baseline
Secondary	Zinc protoporphyrin blood concentration (spectroscopic measurement)	Using fluorescence spectroscopic methods Zinc protoporphyrin blood concentration [unit: µmol/mol heme] will be measured in whole blood samples.	Baseline