Loading clinical trials...
Loading clinical trials...
Iron overload in hereditary hemochromatosis (HH) is treated by phlebotomy. It is unclear, if individuals with hyperferritinemia due to hereditary hemochromatosis or to secondary causes are suitable as blood donors. The study investigates hemolysis and several other quality parameters of red blood cell concentrates (RBC) obtained from 80 individual with ferritin \>500 ng/mL - due to hereditary hemochromatosis or secondary - and 20 healthy blood donors as control.
Iron overload in hereditary hemochromatosis is treated by phlebotomy. In Switzerland and in many other coutries, these individuals are not accepted for blood donation until ferritin values and phlebotomy intervals are in the normal range. Individual with secondary hyperferritinemia, e. g. related to metabolic syndrome, are accepted as blood donors according to their clinical situation. It is unclear if the quality of blood products issued from individuals with hyperferritinemia due to hereditary hemochromatosis or to secondary causes is comparable with the quality of those issued from healthy blood donors, and if their characteristics comply with the international standards. The study investigates the hemolysis rate and several other quality parameters in RBC obtained from 80 individual with ferritin \>500 ng/mL - due to hereditary hemochromatosis or secondary - and 20 healthy blood donors as control. For this purpose, whole blood donations are manufactured according to the standard processes applied in the blood bank. Several standard quality parameters as well as biologic, rheologic, and oxydative stress-related variables are measured and compared, both with the current regulations and with those of the control group.
Age
18 - 75 years
Sex
ALL
Healthy Volunteers
Yes
Blutspendedienst SRK beider Basel
Basel, Switzerland
Interregionale Blutspende SRK
Bern, Switzerland
Start Date
January 18, 2023
Primary Completion Date
December 31, 2023
Completion Date
March 31, 2024
Last Updated
February 23, 2023
100
ESTIMATED participants
Venipuncture
PROCEDURE
Lead Sponsor
Interregionale Blutspende SRK
NCT04202965
NCT03395704
NCT00395629
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and Conditions