Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
CSL Behring
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
