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Enrolling By Invitation
NCT05742035
Quality and Biologic Characteristics of Red Blood Concentrates Obtained From Individuals With Elevated Ferritin.
Conditions: Hereditary Hemochromatosis, Hyperferritinemia
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: 1
Phase: NA
Enrollment: 100
Sponsor: Interregionale Blutspende SRK
Location: Switzerland
Summary
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.
Eligibility Criteria
Inclusion Criteria:Age:18-75 yearsBody weight > 50 KgHaemoglobin ≥ 135 g/l (males), ≥ 125 g/l (females)In subjects of the HH and non-HH group: ferritin values >500 ng/ml, which must have been measured in the last three months before the inclusion in the study (either at the Blood Donation service or elsewhere), not followed by a blood donation or a phlebotomyIn subjects of the HH group: genetic test demonstrating the presence of p.C282Y homozygous or p.C282Y/p.H63D compound heterozygous HFE-gene mutationIn subjects of the control group: ferritin values < 300 ng/ml (males) or < 200 ng/ml (females)Written informed consent to the participation in the studyExclusion Criteria:Inadequate vein access for whole blood collectionBody weight < 50 kgChronic viral infection (hepatitis B or C, HIV)Previous acute coronary heart diseasePrevious or current history of epilepsyOther severe conditions that could significantly increase the phlebotomy risk, based on individual medical evaluationNo informed consentPregnancy (according to the information on the standard blood donor questionnaire)
Source: ClinicalTrials.gov (NCT05742035). StuddyBuddy aggregates publicly available trial information.