Transfusion in Sickle Cell Disease: Screening of Sickle Cell Disease Trait in Blood Donors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 173
- 试验地点
- 3
- 主要终点
- Hemoglobin level -patient
研究概览
简要总结
Bearers of the sickle cell allele (S) are currently eligible for blood donations in Belgium. As blood donors are not tested for this allele, their heterozygous status is unknown. However, guidelines recommend to transfuse sickle cell patients with blood that is negative for the 'S' hemoglobin. To the investigator's knowledge, no study has been conducted to evaluate the impact of transfusion with blood originating from heterozygous donors on the transfusion performance and the improvement of clinical status of the sickle cell disease patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients with sickle cell disease within the CHU Brugmann and the Queen Fabiola Children's Hospital (HUDERF)
排除标准
- 未提供
研究组 & 干预措施
Control - Transfusion prior to surgery
Blood donor not bearer of the sickle cell disease allele (HbAA genotype)
干预措施: Blood sampling (Procedure)
Acute transfusion
Blood donor heterozygous for the sickle cell disease allele (HbAS genotype)
干预措施: Blood sampling (Procedure)
Control - Acute transfusion
Blood donor not bearer of the sickle cell disease allele (HbAA genotype)
干预措施: Blood sampling (Procedure)
Chronic transfusion
Blood donor heterozygous for the sickle cell disease allele (HbAS genotype)
干预措施: Blood sampling (Procedure)
Control - Chronic transfusion
Blood donor not bearer of the sickle cell disease allele (HbAA genotype)
干预措施: Blood sampling (Procedure)
Transfusion prior to surgery
Blood donor heterozygous for the sickle cell disease allele (HbAS genotype)
干预措施: Blood sampling (Procedure)
结局指标
主要结局
Hemoglobin level -patient
时间窗: 1 hour after blood transfusion
Hemoglobin level (g/dL)
% of 'S' type hemoglobin -transfused blood
时间窗: 1 hour before blood transfusion
% of 'S' type hemoglobin (assessed by means of hemoglobin electrophorese)
% of 'S' type hemoglobin -patient
时间窗: 1 hour after blood transfusion
% of 'S' type hemoglobin (assessed by means of hemoglobin electrophorese)
Hemoglobin level - transfused blood
时间窗: 1 hour before blood transfusion
Hemoglobin level (g/dL)
Transfusion yield
时间窗: 1 hour after blood transfusion
Computed by means of a formula taking the level of hemoglobin, the % of 'S' type hemoglobin and the body surface into account.
Medical complications
时间窗: 1 month
List of medical complications having occured after a surgery. Applicable only to the 'transfusion prior to surgery' groups.
Length of stay
时间窗: 1 month
Length of stay within the hospital. Applicable only to the 'acute transfusion' groups
Length of stay post transfusion
时间窗: 1 month
Length of stay within the hospital after a blood transfusion. Applicable only to the 'acute transfusion' groups
Number of blood transfusions
时间窗: 1 month
Number of blood transfusions. Applicable only to the 'acute transfusion' groups
Hospital re-admission
时间窗: 1 month
Hospital re-admission. Applicable only to the 'acute transfusion' groups
Mortality rate
时间窗: 1 month.
Mortality rate. Applicable only to the 'acute transfusion' groups
次要结局
未报告次要终点
研究者
Hanane EL KENZ
Head of Blood Bank
Brugmann University Hospital