Quality and Biologic Characteristics of Red Blood Concentrates Obtained From Individuals With Elevated Ferritin.
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- Hemolysis rate vs regulatory standards.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Assessors of quality parameters don't know the diagnosis of the included participants
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
Hemolysis rate vs regulatory standards.
时间窗: After 42 days of storage
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%.
次要结局
- 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)
研究者
Stefano Fontana
Head of Medical Department, Principal Investigator
Interregionale Blutspende SRK