Ignite Creation Date:
2024-05-06 @ 6:40 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05742035
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2023-02-23
First Post:
2023-02-06
Brief Title:
Quality and Biologic Characteristics of Red Blood Concentrates Obtained From Individuals With Elevated Ferritin
Sponsor:
Interregionale Blutspende SRK
Organization:
Interregionale Blutspende SRK
Study Overview
Official Title:
Quality and Biologic Characteristics of Red Blood Concentrates Obtained From Individuals With Elevated Ferritin
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ngmL - 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 ngmL - 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
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 ngmL - 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None