Aquired FXIII deficiency following cardiopulmonary bypass surgery (CABG (coronary atery bypass grafting) or CABG plus single heart valve replacement/repairs or planned replacement/repair of a single heart valve) MedDRA version: 9.1 Level: LLT Classification code 10063919 Term: Bypass surgery
Conditions
Interventions
Product Name: Recombinant Factor XIII (rFXIII)
Product Code: NN1810
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Catridecacog
CAS Number: 606138-08-3
Other descriptive n
Sponsors
Novo Nordisk A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Informed consent (IC) obtained before any trial-related activities. (Trial related activities are any procedure that would not have been performed during the normal management of the subject). 2. Age: = 18 - = 80 years 3. Subjects scheduled to undergo cardiac surgery (CS) requiring CPB 4. Planned: • CABG or • CABG plus single heart valve replacement/repair or • planned replacement/repair of a single heart valve 5. Intra-operative transfusion risk score of 2 or 3 (Table 3–1 in protocol) 6. Peri-operative use of an antifibrinolytic agent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Known or suspected allergy to trial drug(s) or related products 2. Known intolerance to protamine 3. Known or suspected allergy to the used antifibrinolytic agent 4. Previous randomisation and dosing in this trial 5. The receipt of any investigational drug within 30 days prior to surgery 6. Refusal to receive blood or blood product 7. Planned off pump coronary artery bypass (OPCAB) 8. Planned peri-operative use of Desmopressin (DDAVP) 9. Known heparin induced thrombocytopenia (HIT) 10. Known deficiency of protein C, protein S, antithrombin, or homozygous Factor V Leiden 11. Known congenital bleeding disorders 12. Planned surgery including the aortic arch and/or descending aorta 13. Planned surgery including any implantable ventricular assist device 14. Adult congenital heart diseases 15. Current endocarditis 16. Planned hypothermic circulatory arrest ( 1.5 on the day of surgery in patients treated with vitamin K antagonist 30. Liver dysfunction (aspartate aminotrasferase (AST) or alanine aminotransferase (ALT) increased = 2-fold above the upper limit of local laboratory normal ranges) 31. Renal failure (creatinine = 175 micromol/L or dialysis) 32. Most recent left ventricular ejection fraction < 30% 33. Current thromboembolic disease other than myocardial infarct 34. Planned peri-operative use of fibrin sealants 35. Use of any investigational agent 36. Weight = 140 kg 37. Patients who have pre-donated autologous blood.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate whether postoperative treatment with either of two doses (17.5 or 35 IU/kg LBM) of recombinant factor FXIII (rFXIII) is effective in avoiding any allogeneic transfusions in cardio pulmonary bypass (CPB) surgery subjects with a pre-operative transfusion risk score of 2 or 3;Secondary Objective: To document the safety profile of rFXIII used as replenishment therapy in cardiopulmonary bypass (CPB) surgery. ;Primary end point(s): Percentage of subjects avoiding any allogeneic transfusions (RBC, FFP, platelets, cryoprecipitate, fibrinogen concentrate, clotting factor concentrate) for seven days post-operative or until discharge, whichever comes first. | — |
Countries
Denmark, Germany, Italy, Spain, Sweden, United Kingdom
Outcome results
None listed