EUCTR2007-004612-31-DE进行中（未招募）不适用
Efficacy and safety of Haemocomplettan® P in patients experiencing acute bleedingwhile undergoing aortic replacement surgery - Haemocomplettan® P during aortic replacement
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •· Eighteen years of age or older
- •· Undergoing elective thoracoabdominal aortic replacement surgery (TAAA) or thoracic aortic replacment 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
- •- Clinically relevant bleeding (microvasculature) defined as a 5-minute bleeding mass of 60 to 250 g
- •- Intraoperative conditions prior to administration of study medication are
- •- Body temperature > 36°C
- •- Blood pH > 7.3
- •- Hb > 8.5 g/dL
- •- ACT < 150 seconds
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
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 surgery)
- •· 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.
研究者
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