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

NCT03071497 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2018-07-17

No results posted yet for this study

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).

Conditions

Interventions

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.

Sponsors & Collaborators

  • Ludwig-Maximilians - University of Munich

    collaborator OTHER

  • Johann Wolfgang Goethe University Hospital

    lead OTHER

Principal Investigators

  • Patrick Meybohm, Prof. Dr. · Johann Wolfgang Goethe University Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-03-03
Primary Completion
2018-05-01
Completion
2018-05-01

Countries

  • Germany

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03071497 on ClinicalTrials.gov