Harmful Effects of Transfusion of Older Stored Red Cells: Iron and Inflammation
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Non-transferrin-bound Iron Level
研究概览
简要总结
The purpose of this study is to determine the effects of transfusion of fresh and stored blood on patients.
The investigators hope to test:
- whether a similar effect (older stored blood is associated with worse outcomes) is seen in chronically transfused patients with hemoglobinopathies. This patient population will also allow the investigators to test whether iron- chelation therapy is beneficial in this setting.
- whether washing or cryopreserving the red blood cells has any effect on this outcome.
These findings may explain the immunomodulatory effects of older stored blood in patients and will help us develop safer transfusion products for patients.
详细描述
Epidemiologic studies suggest that older stored blood is associated with worse outcomes in certain hospitalized patients. Storage of red cells is associated with a storage lesion and the survival of transfused red cells decreases with increasing storage time, thus older blood is associated with an increased acute delivery of hemoglobin-iron to the reticuloendothelial system. The investigators have preliminary data in healthy human volunteers suggesting that delivery of a significant iron load to the reticuloendothelial system from aged red cells leads to the elaboration of a potentially toxic form of iron known as non-transferrin-bound iron.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •(Recipient):
- •specific, well-characterized hemoglobinopathy
- •chronic simple transfusion therapy (transfusion episodes < 6 weeks apart in frequency)
- •chronic iron chelation therapy
- •not pregnant by self-report and not planning pregnancy
- •age > 1 year old
排除标准
- •(Recipient):
- •clinically unstable
- •treatment for mental illness
- •imprisonment
- •institutionalization
- •Inclusion Criteria (Donor):
- •21-65 years of age
- •male weight > 130 lbs, female weight > 150 lbs
- •male height > 5'1", female height > 5'5"
- •hemoglobin > 15.0 g/dL
- •reasonably certain of intention to stay in New York City metropolitan area for study duration
- •previously tolerated red blood cell donation
- •Exclusion Criteria (Donor):
- •ineligible for donation based on New York Blood Center blood donor screening questionnaire
- •systolic blood pressure < 90 or > 180 mm Hg, diastolic blood pressure < 50 or > 100 mm Hg
- •heart rate < 50 or > 100
- •temperature > 99.5 F prior to donation
- •positive by standard infectious disease testing performed on blood donors
研究组 & 干预措施
Transfusion of Fresh blood
The recipient will receive one or two units of fresh blood <14 days old, as per their chronic transfusion schedule - on or off chelation therapy.
干预措施: Blood (Biological)
Transfusion of Fresh blood
The recipient will receive one or two units of fresh blood <14 days old, as per their chronic transfusion schedule - on or off chelation therapy.
干预措施: Transfusion (Procedure)
Transfusion of Fresh blood
The recipient will receive one or two units of fresh blood <14 days old, as per their chronic transfusion schedule - on or off chelation therapy.
干预措施: Chelation therapy (Procedure)
Transfusion of Stored blood
The recipient will receive one or two units of old blood >28 days old, as per their chronic transfusion schedule - on or off chelation therapy.
干预措施: Transfusion (Procedure)
Transfusion of Stored blood
The recipient will receive one or two units of old blood >28 days old, as per their chronic transfusion schedule - on or off chelation therapy.
干预措施: Blood (Biological)
Transfusion of Stored blood
The recipient will receive one or two units of old blood >28 days old, as per their chronic transfusion schedule - on or off chelation therapy.
干预措施: Chelation therapy (Procedure)
Transfusion of Cryopreserved Blood
The recipient will receive one or two units of cryopreserved (fresh/old) blood, as per their chronic transfusion schedule - off chelation therapy.
干预措施: Transfusion (Procedure)
Transfusion of Cryopreserved Blood
The recipient will receive one or two units of cryopreserved (fresh/old) blood, as per their chronic transfusion schedule - off chelation therapy.
干预措施: Blood (Biological)
Transfusion of Washed Blood
The recipient will receive one or two units of washed (fresh/old) stored blood >28 days old, as per their chronic transfusion schedule - off chelation therapy.
干预措施: Transfusion (Procedure)
Transfusion of Washed Blood
The recipient will receive one or two units of washed (fresh/old) stored blood >28 days old, as per their chronic transfusion schedule - off chelation therapy.
干预措施: Blood (Biological)
结局指标
主要结局
Non-transferrin-bound Iron Level
时间窗: 2 hours after transfusion
次要结局
未报告次要终点
研究者
Steven L. Spitalnik
Professor of Pathology and Cell Biology
Columbia University