Diagnostic of Iron Deficiency by Means of Non Invasive Measurement of Zink Protoporphyrin IX
ZnPP
1 other identifier
observational
300
1 country
1
Brief Summary
ZnPP is being build in the case of a functional iron deficiency. Zinc instead of iron is implemented into protoporphyrin IX. This ZincProtoporphyrin (ZnPP) can be detected non invasively. Non invasive and invasive optical measurement of ZnPP will be compared. Additionally ZnPP measurements will be compared to other iron deficiency parameters for validation by the investigators.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2017
Shorter than P25 for all trials
1 active site
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
July 24, 2017
CompletedFirst Posted
Study publicly available on registry
July 27, 2017
CompletedStudy Start
First participant enrolled
July 27, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 26, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2018
CompletedJune 8, 2018
June 1, 2018
7 months
July 24, 2017
June 7, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Validation of the non-invasive ZincProtoporphyrinIX measurement
The value is compared to optical measurement of ZincProtoporphyrin in whole blood; in addition the value is compared to HPLC measurement in whole blood
Baseline
Secondary Outcomes (1)
Comparison of the ZincProtoporyphyrinIX value to other iron-deficiency parameters
Baseline
Study Arms (1)
Preoperative patients
Patients present themselves before an operation to the Anesthesiologist. They are screened for study eligibility.
Interventions
Within 30 seconds, a measurement is performed on the lip of a patient to determine a ZincProtoporphyrin value
Eligibility Criteria
Patients prior to a surgery, seen in the Anesthetic clinic for evaluation
You may qualify if:
- Patients seen preoperatively in the Anesthestic clinic
- Patients \> 18 years of age
- Understood and signed patient consent
You may not qualify if:
- transfusion of blood products 8 weeks prior to screening
- Pregnancy
- Porphyria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Philipp Steinlead
Study Sites (1)
University Hospital Zurich
Zurich, 8091, Switzerland
Related Publications (1)
Hennig G, Homann C, Teksan I, Hasbargen U, Hasmuller S, Holdt LM, Khaled N, Sroka R, Stauch T, Stepp H, Vogeser M, Brittenham GM. Non-invasive detection of iron deficiency by fluorescence measurement of erythrocyte zinc protoporphyrin in the lip. Nat Commun. 2016 Feb 17;7:10776. doi: 10.1038/ncomms10776.
PMID: 26883939BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Philipp Stein, MD
Institute of Anesthesiology, University and University Hospital Zurich
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Dr. med Philipp Stein
Study Record Dates
First Submitted
July 24, 2017
First Posted
July 27, 2017
Study Start
July 27, 2017
Primary Completion
February 26, 2018
Study Completion
May 31, 2018
Last Updated
June 8, 2018
Record last verified: 2018-06