Efficacy and Safety of Haemocomplettan® P in Patients Experiencing Microvascular Bleeding While Undergoing Elective Complex Cardiac Surgery
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Isala
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- To determine whether fibrinogen concentrate infusion reduces perioperative blood loss.
研究概览
简要总结
Fibrinogen concentrate is increasingly used in cardiac surgery to reverse coagulopathy. Whether its use reduces blood loss, transfusion and occurrence of clinical adverse events remains unknown.
详细描述
Fibrinogen concentrate is increasingly used in surgical patients suffering excessive bleeding refractory to conventional hemostasis treatment. However, these studies published so far comprise small study groups with questionable study designs.
The aim of this study is to determine whether fibrinogen concentrate reduces blood loss and transfusion in patients undergoing elective complex cardiac surgery.
By choosing the domain of complex cardiac surgery which is prone for excessive blood loss and transfusion, we will focus on subjects undergoing high risk procedures. Hereby we hypothesize that administration of fibrinogen concentrate improves hemostasis in patients experiencing microvascular bleeding during complex cardiac surgery. This improvement of the hemostasis is measured by reduced blood loss and transfusion of blood products during surgery and the postoperative period.
Furthermore, we hypothesize that fibrinogen concentrate is safe and well tolerated in patients undergoing complex cardiac surgery. This hypothesis will be investigated by a detailed study of clinical outcomes.
Update regarding interim-analysis:
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eighteen years of age or older.
- •Undergoing elective complex cardiac surgery.
- •Understood and willingly given written informed consent.
- •Experience clinically relevant non-surgical microvascular bleeding following removal of cardiopulmonary bypass.
排除标准
- •Positive pregnancy test, pregnancy or lactation.
- •Undergoing an emergency operation.
- •Proof or suspicion of a congenital or acquired coagulation disorder.
- •Clopidogrel use in the 5 days preceding surgery.
- •INR >1.4 if on coumadin.
研究组 & 干预措施
Albumin
干预措施: Human albumin (Placebo) (Drug)
Haemocomplettan® P
干预措施: Haemocomplettan® P (Drug)
结局指标
主要结局
To determine whether fibrinogen concentrate infusion reduces perioperative blood loss.
时间窗: within 12 hours.
Perioperative blood loss measured as blood loss in ml between infusion of study medication and closure of chest.
次要结局
- To determine whether fibrinogen concentrate infusion reduces postoperative blood loss.(within 24 hours after infusion of study medication.)
- To determine whether fibrinogen concentrate infusion reduces postoperative transfusion of blood products during elective complex cardiac surgery.(within 24 hours after infusion of study medication.)
- To determine whether fibrinogen concentrate infusion is safe and well-tolerated.(30 days)