Fibrinogen and Bleeding After Cardiac Surgery
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- To evaluate safety of prophylactic fibrinogen infusion in patients with fibrinogen levels in the lower normal range undergoing cardiac surgery
研究概览
简要总结
The study hypothesis is that prophylactic fibrinogen infusion reduces postoperative bleeding and transfusion requirements after coronary artery bypass surgery (CABG) in patients with endogenous fibrinogen levels in the lower normal range. 60 patients will be included in a prospective, randomized double-blind placebo-controlled single center study.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and Females
- •Age 18 years and above
- •Patients eligible for a first-time coronary artery bypass(CABG) surgery with a preoperative fibrinogen plasma concentration under 3,8 g/L
- •Signed informed consent to participate in the study
排除标准
- •Patients undergoing redo surgery
- •Clinical or laboratory signs of bleeding disorder
- •Clinical or laboratory signs of significant liver disease, or,other significant disease or condition which in the investigators judgment interfere with hemostasis
- •Any medications with agents which may interfere with hemostasis within 14 days prior to study start. Clopidogrel and warfarin are withdrawn at least 24 hours before surgery. Oral aspirin is allowed co-medication.
- •Administration of other investigational drugs within eight weeks preceding the preentry examination
- •Pregnant or lactating women
研究组 & 干预措施
Placebo
100 ml infusion of saline is given during 15 minutes after anesthesia induction before start of surgery.
干预措施: Fibrinogen (Drug)
Study drug
Fibrinogen 2g in 100 ml sterile water given during 15 minutes after anestesiainduction before surgery start
干预措施: Fibrinogen (Drug)
结局指标
主要结局
To evaluate safety of prophylactic fibrinogen infusion in patients with fibrinogen levels in the lower normal range undergoing cardiac surgery
时间窗: 2 years
Blood loss first 12 postoperative hours
时间窗: 12h
次要结局
- Transfusions(7 days)
- Biomarkers of coagulation, fibrinolysis and platelet function(7 days)
- Pharmcoeconomic analysis(2 years)
研究者
Anders Jeppssons
Professor
Sahlgrenska University Hospital, Sweden