CTRI/2019/11/021886尚未招募3 期
Allogeneic umbilical cord blood for red cell concentrates (RCC) transfusion in preterminfants - An exploratory clinical trial.
Intramural GATE Research fund from SRIHER1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2019年1月12日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Proportion of red cell concentrates (RCC) transfusions in preterm infants that are covered by UCB
研究概览
简要总结
- The objective of the study is to assess the feasibility and safety of collection, storage and clinical use of allogeneic umbilical cord blood (UCB) for red cell concentrates (RCC) transfusion in preterm infants. UCB will be collected from term neonates born by elective caesarean section using the cord blood collection kit. RCC will be separated from UCB and stored in the blood bank at 2-6’C. Quality parameters namely, blood culture, screen for transfusion transmitted infections, biochemical and haematological parameters will be done in UCB-RCC at weekly intervals. For preterm infants <1500 g birth weight requiring transfusion during NICU stay, RCC from UCB will be used after cross-matching and irradiation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 0.00 Day(s) 至 28.00 Day(s)（—）
- 性别
- All
入选标准
- •For collection of UCB.
- •Term (≥37 weeks gestation) infants delivered by elective caesarean section
- •For transfusion of UCB.
- •Premature infants <1500 g birth weight requiring transfusion during the NICU stay.
排除标准
- •For collection of UCB
- •Mothers positive for HIV, HBsAg, HCV or VDRL
- •Mothers positive for unusual RBC antibodies screen
- •Mother who opt for cord blood banking
- •Maternal-fetal iso-immunization
- •Lack of consent For transfusion of UCB
- •UCB compatible with baby’s blood not available
- •Lack of consent.
结局指标
主要结局
Proportion of red cell concentrates (RCC) transfusions in preterm infants that are covered by UCB
时间窗: Until discharge from the NICU
次要结局
- 1. Success rate of UCB collection after DCC (defined as absolute UCB volume ≥ 25 mL)(2. Volume of UCB collected/volume of RCC obtained)
研究者
研究点 (1)
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