NCT00701142已完成2 期
Haemocomplettan® P in Patients Experiencing Acute Bleeding While Undergoing Aortic Replacement Surgery
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- CSL Behring
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Combined number of units of allogeneic blood products (platelets + FFP + RBCs) administered to subjects.
研究概览
简要总结
The primary purpose is to show that administration of Haemocomplettan® P significantly reduces the amount of blood products needed during aortic surgery.
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, Investigator)
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 thoracoabdominal aortic replacement surgery (TAAA) or thoracic aortic replacement surgery (TAA)
- •Understood and willingly given written informed consent (German language) to participate following an explanation of study background, restrictions, and procedures
- •Experience clinically relevant bleeding of the microvasculature following removal of CPB during surgery
排除标准
- •Positive pregnancy test, pregnancy or lactation
- •Women of child bearing age not using a medically approved method of contraception during the study
- •Previous aortic replacement at the same aortic site (redo surgeries)
- •Undergoing an emergency operation
- •Proof or suspicion of a congenital or acquired coagulation disorder (e.g. VWD or via severe liver disease)
- •Myocardial Infarction (MI) or apoplexy in the 2 months preceding study surgery
- •ASA administration in the 3 days preceding study surgery, and a pathological (<74.5 U) ASPI Multiplate® test immediately preceding surgery begin
- •Clopidogrel administration in the 5 days preceding study surgery, and a pathological (<31.1 U) ADP/PG Multiplate® test immediately preceding surgery begin
- •Tirofiban administration in the 2 days preceding study surgery, and a pathological (<94.1 U) TRAP Multiplate® test immediately preceding surgery begin
- •Phenprocoumon administration in the 5 days preceding study surgery, and an INR > 1.28 immediately preceding surgery begin
- •Participation in another clinical study in the 4 weeks preceding aortic replacement
- •Sensitivity to any of the components of study medication, or to MPs with a similar chemical structure to any of the components of study medication
- •Any indication that the restrictions or procedures of the study may not be adhered to (e.g. an uncooperative attitude)
- •Any indication that the study restrictions, procedures, or consequences therein have not been considered or understood, such that informed consent cannot be convincingly given
- •Multiple morbidities, with a notably constrained remaining length of life
研究组 & 干预措施
Saline solution
Placebo Comparator
干预措施: Saline solution (Biological)
Haemocomplettan® P
Active Comparator
Intravenous infusion during aortic surgery
干预措施: Haemocomplettan® P (Biological)
结局指标
主要结局
Combined number of units of allogeneic blood products (platelets + FFP + RBCs) administered to subjects.
时间窗: From administration of Haemocomplettan® P until 24 hours later
次要结局
- Duration of hospital stay(Last suture of initial surgery to end of hospital stay)
- Proportion of subjects that receive no allogeneic blood products (neither platelets, FFP, nor RBCs)(From administration of Haemocomplettan® P until 24 hours later)
- Duration of stay in ICU(Last suture of initial surgery to end of ICU stay)
- Mortality(45 days post surgery)
研究者
研究点 (1)
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