Profilatic Fibrinogen Concentrate Reduces Postoperative Bleeding in Pediatric Cardiac Surgery With Cardiopulmonary Bypass: Randomized Study
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- The amount of postoperative bleeding
研究概览
简要总结
The purporse of this study is evaluate whether fibrinogen concentrate reduces postoperative bleeding in pediatric cardiac surgery with cardiopulmonary by-pass.
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. Fibrinogen concentrate (Haemocomplettan P)may reduce perioperative bleeding, requirements of blood transfusion and clinical outcomes in children undergoing cardiac surgery with pump.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- — 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cardiac surgery with pump
- •Written informed consent
- •Age under 28 days of life or RACHS-1 equal or greater than 3 or reoperation with age under 10 years
排除标准
- •Coagulopathy (INR > 1.5)
- •Low platelet count (lower than 100.000)
- •Product or albumin allergy
- •Active endocarditis
- •Blalock-Taussig
- •Heart transplant
- •Anemia (hemoglobin < 10 g/dL)
- •Impossibility to receive blood transfusion
- •Hepatic dysfunction (total bilirubin > 1.5 mg/dL)
- •Known or suspected hypersensitivity to fibrinogen concentrate
- •Thrombophilia or previous thrombosis
- •Participation in another study
研究组 & 干预措施
fibrinogen concentrate
patients randomized to fibrinogen group receive intravenous infusion of drug prepared based on ROTEM measurement of maximum clot firmness (MCF)
干预措施: Fibrinogen Concentrate (Drug)
control
patients randomized to the control group will receive the infusion of 0.9% saline (SF0,9%) prepared based on ROTEM measurement of maximum clot firmness (MCF)
干预措施: control (Other)
结局指标
主要结局
The amount of postoperative bleeding
时间窗: Within 7 days after cardiac surgery
The amount of blood loss (tube drainage) in the first 6 hours of ICU admission and daily until the seventh day of ICU. Re-exploration is mandatory if the patient presente excessive bleeding not responsive to clinical measures (warming, coagulopathy correction and/or thrombocytopenia correction), associated hemodynamic instability or evidence of cardiac tamponade.
次要结局
- The amount and type of blood transfusion(within 7 days after cardiac surgery)
- Rate of mortality(within 28 days after cardiac surgery)
- Evaluation of the clot firmness before and after the intervention(After the cardiopulmonary bypass (CPB) weaning and after drug administration during the surgery.)
- Correlation between clot firmness (FIBTEM) and plasma fibrinogen(After the cardiopulmonary bypass (CPB) weaning and after drug administration during the surgery.)
- Evaluation of plasma fibrinogen before and after the intervention(After the cardiopulmonary bypass (CPB) weaning, after drug administration during the surgery and in ICU admission.)
- Length of ICU stay(within 28 days after cardiac surgery)
- Rate of acute kidney injury(within 28 days after cardiac surgery)
- Rate of cardiac complications(within 28 days after cardiac surgery)
- Rate of neurological complications(within 28 days after cardiac surgery)
- Rate of infection complications(within 28 days after cardiac surgery)
- Duration of mechanical ventilation(within 28 days after cardiac surgery)
- Length of vasoactive drugs(within 28 days after cardiac surgery)
- Length of hospital stay(within 28 days after cardiac surgery)
研究者
Filomena R B G Galas
Associate Professor of Anesthesiology at University São Paulo Medical School
Instituto do Coracao