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

NCT05742035 | Unknown

• 1 other identifier: 2022-00274
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Hereditary Hemochromatosis; Hyperferritinemia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Hemolysis hyperferritinemia vs controls end of storage.

  After 42 days of storage

• Hemolysis hereditary hemochromatosis (HH) vs secondary hyperferritinemia entd of storage.

  After 42 days of storage

• Hemolysis hyperferritinemia vs controls day 1.

  After 42 days of storage

Study Arms (3)

Hereditary hemochromatosis

EXPERIMENTAL

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

Procedure: Venipuncture

secondary hyperferritinemia

EXPERIMENTAL

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

Procedure: Venipuncture

healthy blood donor with normal ferritin value.

OTHER

Healthy comparator.

Procedure: Venipuncture

Interventions

Venipuncture 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.

Hereditary hemochromatosis; healthy blood donor with normal ferritin value.; secondary hyperferritinemia

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age:18-75 years
• Body weight \> 50 Kg
• Haemoglobin ≥ 135 g/l (males), ≥ 125 g/l (females)
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Interregionale Blutspende SRK: lead

Study Sites (2)

Blutspendedienst SRK beider Basel

Basel, Switzerland

Location

Interregionale Blutspende SRK

Bern, 3008, Switzerland

Location

MeSH Terms

Conditions

Hemochromatosis; Hyperferritinemia

Interventions

Phlebotomy

Condition Hierarchy (Ancestors)

Metal Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Iron Overload; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Blood Specimen Collection; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Therapeutics; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Assessors of quality parameters don't know the diagnosis of the included participants
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Medical Department, Principal Investigator

Model Details: Prospective inclusion of individual and group allocation according to the collected clinical data and diagnoses.

Study Record Dates

• First Submitted: February 6, 2023
• First Posted: February 23, 2023
• Study Start: January 18, 2023
• Primary Completion: December 31, 2023
• Study Completion: March 31, 2024
• Last Updated: February 23, 2023

Record last verified: 2023-02

Locations

CH (2)