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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 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05742035
Study type Interventional
Source Interregionale Blutspende SRK
Contact
Status Enrolling by invitation
Phase N/A
Start date January 18, 2023
Completion date March 31, 2024
View Details
See also
  Status Clinical Trial Phase
Completed NCT03395704 - A Study of LJPC-401 for the Treatment of Iron Overload in Adult Patients With Hereditary Hemochromatosis Phase 2
Unknown status NCT01398644 - Erythrocytapheresis Versus Phlebotomy as Maintenance Therapy in Hereditary Hemochromatosis (HH) Patients Phase 3
Terminated NCT05238207 - A Study to Evaluate BBI-001 in Hereditary Haemochromatosis (HH) Patients and Iron Deficient Volunteers Phase 1
Completed NCT04202965 - PTG-300 in Subjects With Hereditary Hemochromatosis Phase 2
Completed NCT03203850 - Study to Evaluate the Efficacy and Safety of Deferasirox Film-coated Tablet Versus Phlebotomy in Patients With Hereditary Hemochromatosis (HH) Phase 2
Completed NCT00068159 - Cardiac Function in Patients With Hereditary Hemochromatosis
Completed NCT00395629 - Safety and Efficacy of Deferasirox (ICL670) in Patients With Iron Overload Resulting From Hereditary Hemochromatosis Phase 1/Phase 2
Completed NCT00440986 - Clinical Management of Hereditary Hemochromatosis: Phlebotomy vs. Erythrocytoapheresis Phase 2/Phase 3