Quality and Biologic Characteristics of Red Blood Concentrates Obtained From Individuals With Elevated Ferritin.

Status: Unknown
Location: See all (2) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: t
View:

• Age:18-75 years

• Body weight \> 50 Kg

• Haemoglobin ≥ 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 phlebotomy

• In subjects of the HH group: genetic test demonstrating the presence of p.C282Y homozygous or p.C282Y/p.H63D compound heterozygous HFE-gene mutation

• In subjects of the control group: ferritin values \< 300 ng/ml (males) or \< 200 ng/ml (females)

• Written informed consent to the participation in the study

Locations
Other Locations
Switzerland
Blutspendedienst SRK beider Basel
Basel
Interregionale Blutspende SRK
Bern
Time Frame
Start Date: 2023-01-18
Completion Date: 2024-03-31
Participants
Target number of participants: 100
Treatments
Experimental: Hereditary hemochromatosis
Individual with ferritin \>500 ng/mL and documented homozygous or compound heterozygous HFE-gen mutation.
Experimental: secondary hyperferritinemia
Individual with ferritin \>500 ng/mL, not fulfilling the criteria for hereditary hemochromatosis.
Other: healthy blood donor with normal ferritin value.
Healthy comparator.
Related Therapeutic Areas
Sponsors
Leads: Interregionale Blutspende SRK

This content was sourced from clinicaltrials.gov