Red Blood Cell Survival Study: The Impact of Oxidative Stress on Erythrocyte Biology
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Percentage of Red Blood Cells Surviving
研究概览
简要总结
This study will address if red blood cells transfused to a sickle cell patient from a donor with a glucose-6-phosphate-dehydrogenase (G6PD) enzyme deficiency have a different lifespan as measured by the percentage of red blood cells that survive post-transfusion compared to red blood cells transfused to a sickle cell patient from a donor without a G6PD enzyme deficiency.
详细描述
This prospective, phase II, crossover, single-blind, randomized transfusion order study will address if red blood cells from donors with a G6PD enzyme deficiency have a different lifespan once transfused into a patient with sickle cell disease than red blood cells from an otherwise normal donor. Results of this critical study will guide future research and donor testing policies to ensure that patients receive the most appropriate units of blood for their condition. Each patient randomized to the study will receive 2 blood transfusions, one from a G6PD deficient donor and one from an otherwise normal donor. Half the patients (8) will receive G6PD deficient blood first while the other half (8) will receive non-G6PD deficient blood first. Patients will have a wash-out period of at least 4 months before receiving the opposite type of blood transfusion. The blood transfusion order will be randomized. There is currently no standard of testing in place to screen blood donations for G6PD enzyme deficiency. It is believed that up to 10% of the antigen-matched donors for patients with sickle cell disease are G6PD deficient, and the lifespan is unknown in the sickle cell population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
盲法说明
Patients will not be told which type of blood they are receiving first. There is no way to tell if blood has enzyme deficiencies by looking at it.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-60 years
- •Has diagnosis of sickle cell disease
- •Steady state (no pain or baseline pain and ≥1 month from any hospital admission)
- •Receiving chronic transfusions (i.e., regular transfusion every 4-8 weeks).
排除标准
- •History of transfusion reactions not adequately managed by antihistamines
- •Does not have crossmatch compatible red cells
- •Known G6PD deficiency
- •Hepato- or splenomegaly
- •Participation in another therapeutic trial
- •Pregnant or nursing
- •HIV positive
- •At investigator discretion for uncontrolled inter-current illness or social situation limiting compliance with study requirements.
- •Inability to speak and/or read English
研究组 & 干预措施
G6PD Deficient Red Blood Cell Transfusion, then Non-G6PD deficient Red Blood Cell Transfusion
Transfusion of a red blood cell unit that has been identified by local laboratory procedures to be deficient in G6PD enzyme activity followed after 4 months by transfusion of a red blood cell unit that has been identified by local laboratory procedures to not be deficient in G6PD enzyme activity.
干预措施: G6PD Deficient Red Blood Cell Transfusion (Biological)
G6PD Deficient Red Blood Cell Transfusion, then Non-G6PD deficient Red Blood Cell Transfusion
Transfusion of a red blood cell unit that has been identified by local laboratory procedures to be deficient in G6PD enzyme activity followed after 4 months by transfusion of a red blood cell unit that has been identified by local laboratory procedures to not be deficient in G6PD enzyme activity.
干预措施: Non-G6PD deficient Red Blood Cell Transfusion (Biological)
Non-G6PD deficient Red Blood Cell Transfusion, then G6PD Deficient Red Blood Cell Transfusion,
Transfusion of a red blood cell unit that has been identified by local laboratory procedures to not be deficient in G6PD enzyme activity followed after 4 months by transfusion of a red blood cell unit that has been identified by local laboratory procedures to be deficient in G6PD enzyme activity
干预措施: G6PD Deficient Red Blood Cell Transfusion (Biological)
Non-G6PD deficient Red Blood Cell Transfusion, then G6PD Deficient Red Blood Cell Transfusion,
Transfusion of a red blood cell unit that has been identified by local laboratory procedures to not be deficient in G6PD enzyme activity followed after 4 months by transfusion of a red blood cell unit that has been identified by local laboratory procedures to be deficient in G6PD enzyme activity
干预措施: Non-G6PD deficient Red Blood Cell Transfusion (Biological)
结局指标
主要结局
Percentage of Red Blood Cells Surviving
时间窗: 24 hours post-transfusion
Post-Transfusion Recovery
次要结局
- Mean Percent Change in Hemoglobin A(1 hour post-transfusion, 4 weeks post-transfusion)