Albumin vs. Plasma for PEdiAtric pRiming Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Volume of postoperative bleeding
研究概览
简要总结
This is a randomized controlled trial that compares two different priming composition (albumin vs. fresh frozen plasma) for extracorporeal circulation of pediatric patients under 10 kg of weight. The two approaches are both employed at the moment but there is actually no evidence on the superiority of one over the other. This study is aimed to test the hypothesis that Albumin is superior to fresh frozen plasma in terms of minor bleeding and transfusional requirements.
详细描述
Extracorporeal circulation (ECC) in neonates and infants undergoing cardiac surgery for the correction or palliation of cardiac defects is characterized by temperature variation, activation of coagulation and inflammatory cascades, hemodilution.
An excessive dilution of circulating mass determines a variation in colloid-oncotic pressure (COP) that, together with hydrostatic pressure, induces liquids exchange between interstitial space and plasma. COP variation together with inflammatory response due to extracorporeal circulation and temperature variation is the main determinant of interstitial and pulmonary edema occurrence. Intravascular albumin is responsible for 80% for the COP. Golab et al. randomized a population of neonates and infants undergoing to pediatric cardiac surgery procedures in order to reach two different targets of COP through administration of different albumin amounts. His results didn't show significant differences for primary and secondary endpoints except for postoperative ventilation duration.
Trials on adult patients undergoing cardiac surgery haven't showed differences in bleeding when varying colloid solution employed. Albumin is preferred to artificial colloids due to reduced risk of anaphylactic reactions and for its capacity to maintain COP.
Hemodilution is associated to a reduction in hematocrit, platelet count, fibrinogen and other coagulation factor concentration. Solutions employed for ECC (Extracorporeal Circulation) circuits priming also contain components that could impair hemostasis.
In order to reduce the negative effects on the coagulation, many centers for pediatric surgery employ fresh frozen plasma (FFP) for priming solution. Oliver et al randomized a population of 51 cardiopathic, acyanotic children under 10 kg of weight to receive either albumin or FFP as ECC priming. The authors showed a reduction of postoperative bleeding in the group receiving FFP. No significant differences were detected in postoperative coagulation tests. Other studies with small cohorts weren't able to detect significant differences between the two regimens applied by Oliver and colleagues.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •weight under 10 kg
- •cardiovascular surgery procedure with extracorporeal circulation
- •need for hematic priming solution
- •elective surgery
- •informed consent signed
排除标准
- •congenital disorders of coagulation system
- •emergency surgery
研究组 & 干预措施
Albumin
5% Albumin to be added to the priming solution composed of concentrated red cells to reach a target of 28-30% hematocrit and albumin to reach the standard volume administered to these patients (400 ml)
干预措施: Albumin (Drug)
Fresh Frozen Plasma
Fresh Frozen Plasma to be added to the priming solution composed of concentrated red cells to reach a target of 28-30% hematocrit and plasma to reach the standard volume administered to these patients (400 ml)
干预措施: Fresh Frozen Plasma (Biological)
结局指标
主要结局
Volume of postoperative bleeding
时间窗: 24 hours
Postoperative bleeding in ml/kg, as measured by chest drainage
次要结局
- Hours on artificial ventilation(hours until extubation, an average of 72 hours)
- Number of units of blood components transfused(48 hours)
- Days of hospital stay(days until discharge, an average of 10 days)
- Thromboembolic complications(Postoperative hospital stay until discharge, an average of 10 days)
研究者
Marco Ranucci
MD, FESC
IRCCS Policlinico S. Donato
