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

Hereditary Hemochromatosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05742035
• Other study ID #: 2022-00274
• Status: Enrolling by invitation
• Phase: N/A
• Start date: January 18, 2023
• Est. completion date: March 31, 2024

Study information

• Verified date: February 2023
• Source: Interregionale Blutspende SRK
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: March 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Hemochromatosis
• Hemosiderosis
• Hereditary Hemochromatosis
• Hyperferritinemia

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Switzerland	Blutspendedienst SRK beider Basel	Basel
Switzerland	Interregionale Blutspende SRK	Berne

Sponsors (1)

Lead Sponsor	Collaborator
Interregionale Blutspende SRK

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemolysis rate vs regulatory standards.	To verify that the hemolysis rate in % at the end of storage (day 42) of RBC from individuals with elevated ferritin is within the current accepted European standard of 0.8%.	After 42 days of storage
Secondary	Hemolysis hyperferritinemia vs controls end of storage.	Comparison of haemolysis rate in % at day 42 in RBC from individuals with elevated ferritin of any cause and those with normal ferritin levels.	After 42 days of storage
Secondary	Hemolysis hereditary hemochromatosis (HH) vs secondary hyperferritinemia entd of storage.	Comparisons of hemolysis rate in % at day 42 in RBC from individuals with HH and those with secondary hyperferritinemia.	After 42 days of storage
Secondary	Hemolysis hyperferritinemia vs controls day 1.	Comparisons of hemolysis rate in % at day 1 in RBC from individuals with hyperferritinemia and those with normal ferritin.	After 42 days of storage