Comparison of Fresh Frozen Plasma and Plasmalyte ® for Priming Cardiopulmonary Bypass in Infants and Children Undergoing Open-heart Surgery: A Double-blind Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Increased risk of of donor exposure intraoperatively and postoperatively.
研究概览
简要总结
Coagulation abnormalities after pediatric open-heart surgery are complex and very often multifactorial. Besides the cardiopulmonary bypass (CPB), the congenital pathology and the coagulation tests during CPB, the younger age has been the most significant risk factor for bleeding and transfusion requirements. In children the volume of pump priming is much higher compared with the patient's circulating blood volume. For this reason the CPB tubing system is primed with packed red blood cells and fresh frozen plasma (FFP) to avoid excessive hemodilution and induced coagulopathy. While this is routinely performed in neonates and small infants, the routine priming of CPB system with FFP has been questioned in several randomized prospective studies in older infants. However, the results of these studies are conflicting. Moreover, they show methodological issues.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 2 Months 至 70 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children weighing between 7 and 15 kg and admitted to undergo open-heart surgery with CPB
排除标准
- •Patients with preoperative coagulation abnormalities
- •Parental refusal
- •Emergency surgery
- •Patients with preoperative renal or hepatic dysfunction
研究组 & 干预措施
Fresh Frozen Plasma
The priming of the CPB oxygenator will be done with 15 ml/kg of FFP in addition to packed red blood cells.
干预措施: Surgery with CPB (Procedure)
Plasmalyte
The priming of the CPB oxygenator will be done with 15 ml/kg of Plasmalyte in addition to packed red blood cells.
干预措施: Surgery with CPB (Procedure)
Plasmalyte
The priming of the CPB oxygenator will be done with 15 ml/kg of Plasmalyte in addition to packed red blood cells.
干预措施: Plasmalyte (Other)
Fresh Frozen Plasma
The priming of the CPB oxygenator will be done with 15 ml/kg of FFP in addition to packed red blood cells.
干预措施: Fresh Frozen Plasma (Other)
结局指标
主要结局
Increased risk of of donor exposure intraoperatively and postoperatively.
时间窗: The first 6 hours postoperatively
The total number of different packs of allogeneic blood products administered per child.
Postoperative bleeding (mL blood in the chest tubes). Significant postoperative bleeding is defined as a bleeding of > 5ml/kg/h in the first 6hours postoperatively.
时间窗: The first 6 hours postoperatively
The exact amount of blood loss in the postoperative period per kilogram weight of child.
次要结局
- Comparison of Rotem and Multiplate between both groups.(The first 6 hours postoperatively)
- Volume of transfused allogenic blood products (mL).(The first 6 hours postoperatively)
研究者
Mona Momeni, MD, PhD
Clinical Professor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain