A Phase IV, Randomized, Single Center, Parallel Group Trial of Human Fibrinogen Concentrate (Haemocomplettan) in the Treatment of Dilutional Coagulopathy During Major Pediatric Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- Total amount of transfused red cell concentrate
研究概览
简要总结
The purpose of this study is to compare two different thromboelastometry (ROTEM) trigger levels for administration of human fibrinogen concentrate (Haemocomplettan P) in the treatment of perioperative dilutional coagulopathy during major pediatric surgery. The study hypothesis is that administration of fibrinogen concentrate triggered by a ROTEM FibTEM MCF < 13 mm might reduce the total amount of transfused red cell concentrate during 24 hours after start of surgery as compared to a trigger level of ROTEM FibTEM MCF < 8 mm.
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
- Single (Participant)
入排标准
- 年龄范围
- 6 Months 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and Females
- •Age 6 months to 17 years
- •Scheduled for elective scoliosis surgery or major craniofacial surgery
- •Written informed consent has been obtained
- •Intraoperative hypofibrinogenemia according to definition of treatment groups
排除标准
- •Preexisting congenital or acquired coagulation disorder
- •Medical history of estimated increased bleeding tendency
- •Ongoing coagulation therapy
- •Clinical signs or diagnosis of acute thromboembolism
- •Intolerance of study drug
- •Participation at another clinical trial
- •Pregnant or lactating women
研究组 & 干预措施
Fibrinogen if FibTEM < 8 mm
Administration of fibrinogen concentrate if ROTEM FibTEM revealed MCF < 8 mm
干预措施: Human fibrinogen concentrate (Drug)
Fibrinogen if FibTEM < 13 mm
Administration of fibrinogen concentrate if ROTEM FibTEM revealed MCF < 13 mm
干预措施: Human fibrinogen concentrate (Drug)
结局指标
主要结局
Total amount of transfused red cell concentrate
时间窗: 24 hours after start of surgery
次要结局
- length of stay on PICU(14 days after surgery or discharge of hospital, whatever occurs earlier)
- Additional transfusion/blood products requirements(24 hours after start of surgery)
- Occurence of re-bleeding, surgical revision(14 days after surgery or discharge of hospital, whatever occurs earlier)
- Occurence of (severe) adverse events(14 days after surgery or discharge of hospital, whatever occurs earlier)
- coagulation measurements(24 hours after start of surgery)