NCT03071497

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 25, 2017

Completed
6 days until next milestone

Study Start

First participant enrolled

March 3, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 7, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

July 17, 2018

Status Verified

July 1, 2018

Enrollment Period

1.2 years

First QC Date

February 25, 2017

Last Update Submit

July 14, 2018

Conditions

Iron-deficiencyAnemiaIron Deficiency Anemia

Keywords

Iron-deficiencyAnemiaIron-deficiency AnemiaZinc protoporphyrin

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Zinc protoporphyrin blood concentration (HPLC reference measurement)

    Baseline

  • Zinc protoporphyrin blood concentration (spectroscopic measurement)

    Baseline

Other Outcomes (7)

  • Hemoglobin

    Baseline

  • MCH

    Baseline

  • MCV

    Baseline

  • +4 more other outcomes

Study Arms (1)

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

Interventions

Non-invasive analysis of Zinc protoporphyrinDIAGNOSTIC_TEST

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.

Study Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Age \> 18 years

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johann Wolfgang Goethe University Hospital

Frankfurt am Main, Hesse, 60590, Germany

Location

MeSH Terms

Conditions

Anemia, Iron-DeficiencyAnemia

Condition Hierarchy (Ancestors)

Anemia, HypochromicHematologic DiseasesHemic and Lymphatic DiseasesIron DeficienciesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Patrick Meybohm, Prof. Dr.

    Johann Wolfgang Goethe University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. Patrick Meybohm

Study Record Dates

First Submitted

February 25, 2017

First Posted

March 7, 2017

Study Start

March 3, 2017

Primary Completion

May 1, 2018

Study Completion

May 1, 2018

Last Updated

July 17, 2018

Record last verified: 2018-07

Locations

DE(1)