Health Condition 1: null- Complex Cardiovascular Surgery
Conditions
Interventions
Intervention1: Fibrinogen: Single IV dose, individually determined dose of Fibrinogen Concentrate (Human) (FCH) based on intraoperative FIBTEM (Fibrinogen thrombelastometry) maximum clot firmness (MCF
Sponsors
CSL Behring GmbH
PAREXEL International Clinical Research Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: Subjects meeting all of the following inclusion criteria at the corresponding time points may be enrolled into the study: At Screening: •Undergoing elective open surgical procedures on any part of the aorta requiring CPB, with or without other cardiac surgical procedures (e.g. valve replacement or repair, coronary artery bypass grafting, etc.). •18 years of age or older. •Written informed consent for study participation obtained before undergoing any study specific procedures. Intraoperative (at the 1st 5-minute bleeding mass) •A 5-minute bleeding mass of 60 to 250 g after discontinuation of CPB, administration of protamine, and establishment of surgical hemostasis. •Minimum core body temperature 35°C, measured according to local practice. •Activated clotting time (ACT) ±25% of baseline levels. •Blood pH >7.3
Exclusion criteria
Exclusion criteria: Subjects meeting any of the following exclusion criteria must not be enrolled into the study At Screening and/or baseline: • Undergoing emergency aortic repair surgery. • Reoperative aortic surgery at the same anatomic site as the original procedure (including resternotomy). • Any operation for infection. • Proof or suspicion of a congenital or acquired coagulation disorder (e.g. Von Willebrandâ??s disease, hemophilia or severe liver disease) or a prothrombotic disorder (e.g. protein C or S deficiency). • Myocardial infarction (MI), acute coronary syndrome or stroke in the 2 months preceding study surgery. • Symptomatic carotid or vertebral artery disease. • Planned concomitant peripheral vascular procedure (e.g. carotid endarterectomy). • Low molecular weight or unfractionated heparin in the 24 hours preceding study surgery. • Clopidogrel administration within 5 days preceding study surgery or prasugrel administration within 7 days preceding study surgery or ticagrelor administration in the 24 hours preceding study surgery. • Factor Xa inhibitors within 2 days preceding study surgery. • IIb/IIIa antagonist administration in the 24 hours preceding study surgery. • Use of direct thrombin inhibitors: within 3 days preceding study surgery for dabigatran and within 24 hours preceding study surgery for all others. • An international normalized ratio (INR) >1.3 immediately preceding the start of surgery. • Multiple morbidities, including those that may be discovered during pre-operative evaluation, that result in an anticipated life expectancy • Participation in another interventional clinical study (or use of another IMP) within 30 days before, or during, the study. Participation in an observational clinical study is permitted. • Alcohol, drug, or medication abuse within 1 year before the study that would preclude participation and compliance with study requirements. • Use of concomitant therapy not permitted during the study are: o Therapy with coagulation-promoting medicinal products, including cryoprecipitate, other than those antifibrinolytics listed above and topical hemostatic agents in the 24 hours after IMP administration. o Anti-coagulation medicinal products as defined in the exclusion criteria should not be administered in the 24 hours after IMP administration. o FFP and hydroxyethyl starch are to be excluded from the fluids used to prime the CPB circuit o Hydroxyethyl starch during the surgical procedure o Subjects are not to be enrolled into the study if they receive any prohibited concomitant therapy that cannot be discontinued or are anticipated to require any prohibited concomitant therapy • Suspected inability to understand or unwillingness to comply with study procedures. • Mental condition rendering the subject (or the subjectâ??s legally acceptable representative[s]) unable to understand the nature, scope, and possible consequences of the study. • Known or suspected hypersensitivity to the IMP, or to any excipients of the IMP. • Known or suspected antibodies to the IMP, or to any
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of units of all allogeneic blood products combined (FFP, platelets, and/or red blood cells [RBCs]) administered during the first 24 hours (Time-point) after administration of IMP.Timepoint: First 24 hours (Time-point) after administration of IMP. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in 5-minute bleeding mass between the pre-treatment and the first post-treatment measurementsTimepoint: 1st 5-min bleeding mass measurement and 2nd 5-min bleeding mass measurement.;Consumption of each individual blood product administered (FFP, platelets, and RBCs) during the first 24 hours after administration of IMP and up to 10 days post surgeryTimepoint: First 24 hours after administration of IMP and up to 10 days post surgery;Mortality with adjudicated cause of death during the first 24 hours after administration of IMP, and up to 10 days and 30 days post surgery.Timepoint: First 24 hours after administration of IMP, up to 10 days and 30 days post surgery;Number of units of all allogeneic blood products combined (FFP, platelets, and/or RBCs) administered during the first 6 and 12 hours after administration of IMPTimepoint: First 6 and 12 hours after administration of IMP;Quantity of blood loss (blood drainage volume from the chest) 6 hours, 12 hours and 24 hours after skin closure.Timepoint: 6 hours, 12 hours and 24 hours after skin closure.;Time from administration of study drug to completion of skin closureTimepoint: IMP infusion and Skin Closure;Total avoidance of allogeneic blood transfusions: number and proportion of subjects who are alive and do not have any administration of platelets, FFP, and RBCs during the first 24 hours after administration of IMP.Timepoint: First 24 hours after administration of IMP.;Volume of all allogeneic blood products combined (FFP, platelets, and/or RBCs) administered during the first 6, 12, and 24 hours after administration of IMP.Timepoint: First 6, 12, and 24 hours after administration of IMP | — |
Countries
Austria, Brazil, Canada, Czech Republic, Denmark, Finland, Germany, India, Italy, Japan, Poland, United Kingdom
Contacts
Public ContactDr Annappa Kamath
PAREXEL International Clinical Research Private Limited
Outcome results
None listed