Effect of Glucose-6-phosphate Dehydrogenase Deficiency on Donor Red Blood Cell Storage
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- 24-hour post-transfusion red blood cell recovery
研究概览
简要总结
The proposed study will determine whether G6PD-deficient RBCs store differently than normal RBCs under standard blood banking conditions. The investigators plan to screen a large number of healthy male volunteers for G6PD deficiency in order to identify 10 G6PD deficient and 30 matched normal individuals using a blood sample obtained from a finger-stick. The identified individuals will then be asked to donate a unit of blood that will be stored for up to 42 days and various tests will be performed on these units during storage. At 6 weeks of storage a portion of the unit will be radioactively labeled and re-infused into the volunteer. Blood samples will be drawn before, during, and after the infusion to measure how well or poorly the red blood cells survive after transfusion.
详细描述
Glucose-6-phosphate dehydrogenase (G6PD) deficiency is the most common enzyme deficiency, affecting approximately 400 million people world-wide. It manifests as red blood cell (RBC) destruction in response to oxidative stress, which can be precipitated by infection, and by the ingestion of certain medications and foods. The prevalence of G6PD deficiency varies among populations and is most commonly found in individuals from sub-Saharan Africa, the Mediterranean region, and south-east Asia. Although in most studies G6PD-deficient individuals have normal RBC survival at steady-state, this may vary based upon the G6PD variant present, and some individuals may have shortened RBC survival. While it is not routine practice to screen blood donors for G6PD deficiency, G6PD deficient donor RBCs may store more poorly than normal RBCs. In addition, the transfusion of stored G6PD-deficient RBCs may result in decreased RBC survival after transfusion compared to RBCs from normal donors.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Weight greater than 110 pounds
- •Hemoglobin greater than 11.5 g/dL
- •African (e.g., Afro-American, Afro-Caribbean, Sub-Saharan), Asian, Hispanic, Middle Eastern, or Mediterranean (e.g., Italian, Greek) based on mother's ancestry
- •English speaking
排除标准
- •Presence of hemoglobin variant
- •Ineligible for donation based on the New York Blood Center donor autologous questionnaire
- •Systolic blood pressure >180 or <90 mm Hg, diastolic blood pressure >100 or <50 mm Hg
- •Heart rate <50 or >100
- •Temperature >99.5°F prior to donation
- •Temperature >100.4°F or subjective feeling of illness prior to transfusion (this criterion is to avoid concurrent illness affecting post-transfusion measurements)
- •Positive results on standard blood donor infectious disease testing
研究组 & 干预措施
G6PD-normal
Donated blood from G6PD-normal subjects
干预措施: Sodium Chromate Cr51 (Drug)
G6PD-deficient
Donated blood from G6PD-deficient subjects
干预措施: Sodium Chromate Cr51 (Drug)
结局指标
主要结局
24-hour post-transfusion red blood cell recovery
时间窗: 24 hours
Percentage of radio-labeled red blood cells remaining 24 hours after infusion
次要结局
- In vitro hemolysis rate(42 days)