Acute bleeding while undergoing aortic replacement surgery MedDRA version: 9.1 Level: LLT Classification code 10061651 Term: Aortic surgery
Conditions
Interventions
Trade Name: Haemocomplettan® P
Product Code: BI3023
Pharmaceutical Form: Powder and solvent for solution for infusion
Other descriptive name: HUMAN FIBRINOGEN
Concentration unit: % (W/V) percent weigh
Sponsors
CSL Behring GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: · 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 AND - Intraoperative conditions prior to administration of study medication are - Body temperature > 36°C - Blood pH > 7.3 - Hb > 8.5 g/dL - ACT =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 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 ( 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 |
|---|---|
| Main Objective: To determine if Haemocomplettan® P effectively reduces the amount of allogeneic blood products needed in patients experiencing acute bleeding during aortic-replacement surgery;Secondary Objective: To determine if Haemocomplettan® P is safe and well-tolerated in patients experiencing acute bleeding during aortic-replacement surgery;Primary end point(s): Combined number of units of allogeneic blood products (platelets + FFP + RBCs) administered to subjects, between administration of study medication and 24 hours thereafter | — |
Countries
Germany
Outcome results
None listed