A study of fibrinogen concentrate (FGTW) compared to placebo in the management of bleeding in patients undergoing complex cardiac surgery

INTERVENTION: Product Name: , Product Code:SCP12491473, Pharmaceutical Form: , Other descriptive name: , Strength: , Product Name: 0.9% Sodium Chloride Solution, Product Code:N/A, Pharmaceutical Form: N/A, Other descriptive name: N/A , Strength: , Pharmaceutical form of the placebo: N/A CONDITION: Bleeding in patients undergoing comple Xcardiac surgery involving Cardiopulmonary bypass ; MedDRA version: 20.0Level: LLTClassification code: 10017501Term: Functional disturbances following cardiac surgery Class: 10022117 MedDRA version: 20.0Level: LLTClassification code: 10017501Term: Functional disturbances following cardiac surgery Class: 10022117 Therapeutic area: Diseases [C] ‐ Cardiovascular Diseases [C14] PRIMARY OUTCOME: Main Objective: The primary objective of the study is to evaluate the efficacy of FGTW in combination with Standard of care in reducing the need for allogeneic transfusions within the first 24 hours after randomization in complex cardiac surgery patients. Primary end point(s): The primary efficacy endpoint is the number of units of allogeneic blood products (RBC plus FFP plus platelet concentrate) given to patients between randomization and 24 hours thereafter. Secondary Objective: To evaluate the efficacy associated with the use of FGTW versus Placebo in reducing the number and volume of RBC, FFP, and platelet concentrate transfusions between 24 hours after randomization and the hospital discharge ‐ To evaluate the efficacy associated with the use of FGTW versus Placebo in reducing the blood drainage volume within 12 hours after randomization ‐ To evaluate the number of patients with total avoidance of allogeneic transfusions after randomization ‐ To evaluate the safety of FGTW ‐ To evaluate the impact of FGTW on mortality and surgical morbidity ‐ To evaluate the duration of hospitalization in both treatment arms ‐ To evaluate the length of stay in ICU in both treatment arms SECONDARY OUTCOME: Secondary end point(s):Blood drainage volume within 12 hours after randomization Secondary end point(s):Duration of hospitalization Secondary end point(s):Length of stay in ICU Secondary end point(s):Mortality at 24 hours, 7 days, and 30 days after randomization Secondary end point(s):Number of pre‐donated autologous RBC concentrate units, RBC concentrate prepared by cell‐saver, colloids, and crystalloids after randomization Secondary end point(s):Number of transfusion units infused between 24 hours after randomization and the hospital discharge for each class of allogeneic blood product (RBC, FFP, and platelet concentrate) Secondary end point(s):Percentage of patients receiving aPCCs, rFVIIa, cryoprecipitate or additional FC as rescue therapy within 24 hours after randomization Secondary end point(s):Percentage of patients with each surgical morbidity at 24 hours, 7 days, and 30 days after randomization (see Section 9.2.8) Secondary end point(s):Percentage of patients with fibrinogen concentration below the LLN from visit 2 to visit 5 Secondary end point(s):Percentage of patients with post‐surgery stage 1 AKI (with increase in creatinine by >50% from baseline until hospital discharge) Secondary end point(s):Percentage of patients with surgical re‐exploration for bleeding within 24 hours after randomization Secondary end point(s):Percentage of patients with total avoidance of allogeneic transfusions within 24 hours after randomization Secondary end point(s):Volume of transfusion units infused between 24 hours after randomization and the hospital discharge for each class of allogeneic blood product (RBC, FFP, and platelet concentrate) INCLUSION CRITERIA: Male or female adult patients =18 years, Patients undergoing a planned comple Xcardiac surgery procedure involving CPB, including reoperation and/or comple Xsurgical procedures. Comple Xsurgical procedures are defined as any procedure other than first time isolated coronary artery bypass grafting (CABG), single valve repair/replacement and repair of atrial septal defect (ASD). This criterion represents the main eligibility criterion and so used in the definition of the full analysis set., With a FIBTEM MCF =10 mm during the last 20 minutes of CPB., Patients requiring an IMP dose =8 g calculated with the formula based on patient's weight and the value of FIBTEM MCF, Signed and dated informed consent form (ICF), Willingness to comply with all study procedures and availability for the duration of the study, Covered by healthcare insurance in accordance with local requirements, FIBTEM MCF =14 mm during the screening period prior to the surgery. FIBTEM MCF is the recomme