Differences in coagulation between fresh frozen plasma and Solvent-detergent plasma in pediatric congenital heart surgery
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Primary outcome involves the difference of coagulation variables measured just after surgery between FFP or Omniplasma use. The coagulation variables of interest are protein C activity, protein S activity, α2-antiplasmin, antithrombin, plasminogen, Hb, thrombocyte count, ROTEM, aPTT, PT and fibrinogen.
研究概览
简要总结
To investigate the differences in coagulation variables just after surgery between FFP and S/D plasma (Omniplasma) use. The main coagulation variables of interest are protein S activity and α2-ntiplasmin. Other important coagulation variables are aPTT, PT, ROTEM, fibrinolysis (measured with ROTEM) fibrinogen, Hb, thrombocyte count, protein C activity, antithrombin and plasminogen.
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 否
入选标准
- •Informed consent
- •Cardiac surgery with the use of CPB
- •Group 1A and Group 2A children < 1 year old
- •Group 1B and Group 2B Glenn / Fontan surgery
排除标准
- •No informed consent
- •Cardiac surgery without the use of CPB
- •Preoperative known coagulation disorders
- •Known allergy for FFP or Omniplasma
结局指标
主要结局
Primary outcome involves the difference of coagulation variables measured just after surgery between FFP or Omniplasma use. The coagulation variables of interest are protein C activity, protein S activity, α2-antiplasmin, antithrombin, plasminogen, Hb, thrombocyte count, ROTEM, aPTT, PT and fibrinogen.
Primary outcome involves the difference of coagulation variables measured just after surgery between FFP or Omniplasma use. The coagulation variables of interest are protein C activity, protein S activity, α2-antiplasmin, antithrombin, plasminogen, Hb, thrombocyte count, ROTEM, aPTT, PT and fibrinogen.
次要结局
未报告次要终点
研究者
Research office Cardiothoracic Surgery
Scientific
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)