Aortic Aneurysm
Conditions
Brief summary
The primary purpose is to show that administration of Haemocomplettan® P significantly reduces the amount of blood products needed during aortic surgery.
Interventions
BIOLOGICALHaemocomplettan® P
Single intravenous infusion
BIOLOGICALSaline solution
Single intravenous infusion
Sponsors
CSL Behring
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Combined number of units of allogeneic blood products (platelets + FFP + RBCs) administered to subjects. | From administration of Haemocomplettan® P until 24 hours later |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Duration of hospital stay | Last suture of initial surgery to end of hospital stay |
| Mortality | 45 days post surgery |
Countries
Germany
Outcome results
None listed