60 patients undergoing coronary artery bypass surgery MedDRA version: 9.1 Level: LLT Classification code 10011077 Term: Coronary artery bypass
Conditions
Interventions
Trade Name: Haemocomplettan
Product Name: Haemocomplettan
Pharmaceutical Form: Concentrate for solution for infusion
Other descriptive name: FIBRINOGEN, HUMAN
Concentration unit: g gram(s)
Concentrati
Sponsors
Sahlgrenska Universitetssjukhuset
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Males and females; age 18 years and above • Patients eligible for a first-time coronary artery bypass graft (CABG) surgery with a preoperative fibrinogen plasma concentration =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Patients undergoing reoperation • Clinical or laboratory signs of known bleeding disorder, • Clinical or laboratory signs of significant liver disease, or other significant disease or condition which in the investigators judgment may interfere with hemostasis • Any medication with agents which may interfere with hemostasis within 14 days prior to study start. Clopidogrel och warfarin are withdrawn at least five days before surgery. Heparin and low-molecular heparin are withdrawn at least 24 hours before surgery. Oral aspirin is allowed co-medication. • Administration of other investigational drugs within eight weeks preceding the pre-entry examination • Pregnant or lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To confirm safety and efficacy of prophylactic fibrinogen infusion in patients with fibrinogen levels in the lower normal range undergoing coronary artery bypass grafting (CABG). Primary effect variables is efficacy of fibrinogen infusion on number of transfusions with blood products during hospital stay. ;Secondary Objective: Secondary effects variables are effects of fibrinogen on bleeding volume after surgery, postoperative haemoglobin levels 12 and 24 h after surgery, pharmacoecomic effects, and effects of fibrinogen infusions on laboratory variables assessing global hemostasis, coagulation, fibrinolysis and platelet function. Primary safety variables safety and tolerability as assessed by clinically detectable adverse events during hospital stay. Further on, overall safety and tolerability variables such as adverse events, vital signs (BP, HR, ECG), haematology, biochemistry, and urine analysis will also be evaluated. ;Primary end point(s): Primary effect variables is efficacy of fibrinogen infusion on number of transfusions with blood products during hospital stay. | — |
Countries
Sweden
Outcome results
None listed