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

This study is currently recruiting participants.
Verified March 2017 by Dr. Patrick Meybohm, M.D., Johann Wolfgang Goethe University Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT03071497
First Posted: March 7, 2017
Last Update Posted: March 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Ludwig-Maximilians - University of Munich
Information provided by (Responsible Party):
Dr. Patrick Meybohm, M.D., Johann Wolfgang Goethe University Hospital
  Purpose
  • 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).

Condition Intervention
Iron-deficiency Anemia Iron Deficiency Anemia Diagnostic Test: Non-invasive analysis of Zinc protoporphyrin

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Non-invasive Diagnostics of Iron Deficiency in Surgical Patients by Measuring Zinc Protoporphyrin-IX

Resource links provided by NLM:


Further study details as provided by Dr. Patrick Meybohm, M.D., Johann Wolfgang Goethe University Hospital:

Primary Outcome Measures:
  • Zinc protoporphyrin blood concentration (non-invasive measurement) [ Time Frame: 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:
  • Zinc protoporphyrin blood concentration (HPLC reference measurement) [ Time Frame: Baseline ]
    Using HPLC, the analytical reference method, Zinc protoporphyrin blood concentration [unit: µmol/mol heme] will be measured in whole blood samples.

  • Zinc protoporphyrin blood concentration (spectroscopic measurement) [ Time Frame: Baseline ]
    Using fluorescence spectroscopic methods Zinc protoporphyrin blood concentration [unit: µmol/mol heme] will be measured in whole blood samples.


Other Outcome Measures:
  • Hemoglobin [ Time Frame: Baseline ]

    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).


  • MCH [ Time Frame: Baseline ]

    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).


  • MCV [ Time Frame: Baseline ]

    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).


  • Ferritin [ Time Frame: Baseline ]

    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).


  • CRP [ Time Frame: Baseline ]

    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).


  • Transferrin saturation [ Time Frame: Baseline ]

    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).


  • Soluble transferrin receptor [ Time Frame: Baseline ]

    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).



Estimated Enrollment: 300
Actual Study Start Date: March 3, 2017
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Study Group
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.
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.

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

Inclusion Criteria:

  • Age > 18 years

Exclusion Criteria:

  • Patients who received a blood transfusion less than 8 weeks before examination
  • Pregnancy
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03071497


Contacts
Contact: Patrick Meybohm, Prof. Dr. +49 (0) 69 630187461 patrick.meybohm@kgu.de
Contact: Christoph Fuellenbach, Dr. + 49 (0) 69 630187328 christoph.fuellenbach@kgu.de

Locations
Germany
Johann Wolfgang Goethe University Hospital Recruiting
Frankfurt am Main, Hesse, Germany, 60590
Contact: Patrick Meybohm, Prof. Dr.    +49 (0) 69 630187461    patrick.meybohm@kgu.de   
Contact: Christoph Fuellenbach, Dr.    +49 (0) 69 630187328    christoph.fuellenbach@kgu.de   
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospital
Ludwig-Maximilians - University of Munich
Investigators
Principal Investigator: Patrick Meybohm, Prof. Dr. Johann Wolfgang Goethe University Hospital
  More Information

Responsible Party: Dr. Patrick Meybohm, M.D., Prof. Dr. Patrick Meybohm, Johann Wolfgang Goethe University Hospital
ClinicalTrials.gov Identifier: NCT03071497     History of Changes
Other Study ID Numbers: 468/16
First Submitted: February 25, 2017
First Posted: March 7, 2017
Last Update Posted: March 10, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dr. Patrick Meybohm, M.D., Johann Wolfgang Goethe University Hospital:
Iron-deficiency
Anemia
Iron-deficiency Anemia
Zinc protoporphyrin

Additional relevant MeSH terms:
Anemia
Anemia, Iron-Deficiency
Hematologic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Iron
Zinc
Protoporphyrin IX
Zinc protoporphyrin
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Photosensitizing Agents
Dermatologic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action