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

NCT ID: NCT05742035

Last Updated: 2023-02-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-18
• Study Completion Date: 2024-03-31

Brief 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.

Detailed Description

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.

Conditions

Hereditary Hemochromatosis; Hyperferritinemia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Hereditary hemochromatosis

Individual with ferritin \>500 ng/mL and documented homozygous or compound heterozygous HFE-gen mutation.

Group Type: EXPERIMENTAL

Venipuncture

Intervention Type: PROCEDURE

Bloodletting of 450 mL, followed by separation of the whole blood in 2 blood components: 1 red blood cell concentrate and 1 plasma. Measurement of the outcomes in the red blood cell concentrate.

secondary hyperferritinemia

Individual with ferritin \>500 ng/mL, not fulfilling the criteria for hereditary hemochromatosis.

Group Type: EXPERIMENTAL

Venipuncture

Intervention Type: PROCEDURE

Bloodletting of 450 mL, followed by separation of the whole blood in 2 blood components: 1 red blood cell concentrate and 1 plasma. Measurement of the outcomes in the red blood cell concentrate.

healthy blood donor with normal ferritin value.

Healthy comparator.

Group Type: OTHER

Venipuncture

Intervention Type: PROCEDURE

Bloodletting of 450 mL, followed by separation of the whole blood in 2 blood components: 1 red blood cell concentrate and 1 plasma. Measurement of the outcomes in the red blood cell concentrate.

Interventions

Venipuncture

Bloodletting of 450 mL, followed by separation of the whole blood in 2 blood components: 1 red blood cell concentrate and 1 plasma. Measurement of the outcomes in the red blood cell concentrate.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• Inadequate vein access for whole blood collection
• Body weight < 50 kg
• Chronic viral infection (hepatitis B or C, HIV)
• Previous acute coronary heart disease
• Previous or current history of epilepsy
• Other severe conditions that could significantly increase the phlebotomy risk, based on individual medical evaluation
• No informed consent
• Pregnancy (according to the information on the standard blood donor questionnaire)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Interregionale Blutspende SRK

OTHER

Sponsor Role: lead

Responsible Party

Stefano Fontana

Head of Medical Department, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Blutspendedienst SRK beider Basel

Basel, , Switzerland

Interregionale Blutspende SRK

Bern, , Switzerland

Countries

Switzerland

Other Identifiers

2022-00274

Identifier Type: -

Identifier Source: org_study_id