Fibrinogen Concentrate to Treat Bleeding in Children Undergoing Cardiac Surgery With Pump: a Randomised Controlled Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Number of patients receiving any allogeneic blood products
研究概览
简要总结
The purpose of this study is to evaluate prospectively whether concentrate fibrinogen reduces blood losses, transfusion requirements and occurrence of clinical complications compared to cryoprecipitate in children after cardiac surgery with pump.
详细描述
Cardiac surgery in children may be associated with excessive perioperative bleeding. Perioperative excessive bleeding is associated with need of transfusion with allogeneic blood products such as red blood cells, fresh frozen plasma, platelet pools, and cryoprecipitate. Furthermore, bleeding may result in re-exploration, which is associated with increased morbidity and mortality.Recent studies have shown that patients and children undergoing cardiac surgery with pump often experience a significant drop in their levels and function of fibrinogen, and it would be in part responsible for the bleeding. In most centre world-wide, it is common practice to treat bleeding in these patients with cryoprecipitate in order to substitute fibrinogen. Fibrinogen concentrate (Haemocomplettan P)may reduce perioperative bleeding, requirements of blood transfusion and clinical outcomes in children undergoing cardiac surgery with pump, compared to cryoprecipitate.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cardiac surgery with pump
- •Age until 18 years
- •Written informed consent
- •Clinically important bleeding in intraoperative
- •Fibrinogen lower than 1 g/L or TEG < 7 mm
排除标准
- •Previous coagulopathy (clinical history or INR > 1.5)
- •Low platelet count (lower than 100.000)
- •Product allergy
- •Urgent procedures
- •Active infection
研究组 & 干预措施
Fibrinogen concentrate
干预措施: Fibrinogen concentrate (Drug)
Cryoprecipitate
干预措施: Cryoprecipitate (Drug)
结局指标
主要结局
Number of patients receiving any allogeneic blood products
时间窗: From ICU admission until hospital discharge
Percentage of patients exposed to allogeneic blood products (red blood cells, FFP, platelet concentrate and cryoprecipitate) after ICU admission until hospital discharge.
次要结局
- Vasopressors free-days(Up to ICU discharge)
- intraoperative transfusion(intraoperative period)
- Length of ICU stay(Up to ICU discharge)
- Clinical complications - renal failure, respiratory failure,sepsis, myocardial ischemia, stroke(Up to hospital discharge)
- Mechanical ventilation free-days(Up to ICU discharge)
- Length of hospital stay(Up to hospital discharge)
- postoperative blood losses(from ICU admission until hospital discharge)
研究者
Ludhmila Abrahão Hajjar
Principal Investigator
University of Sao Paulo