Study terminated prematurely due to futility

Cardiac surgery patients have a risk to need allogeneic blood transfusions that depends on several risk factors, e.g. the type of surgery, concomitant medication with anticoagulants, and postoperative chest tube output. Allogeneic blood transfusion is associated with transfusion reactions, infection transmission, and postoperative morbidity and mortality. The aim of this study is to investigate, whether cardiac surgery patients have a reduced postoperative chest tube output and transfusion need when using a point-of-care guided transfusion algorithm compared to standard of care transfusion protocols.

Cardiac surgery patients have a risk to need allogeneic blood transfusions that depends on several risk factors, e.g. the type of surgery, concomitant medication with anticoagulants, and postoperative chest tube output. Allogeneic blood transfusion is associated with transfusion reactions, infection transmission, and postoperative morbidity and mortality. The aim of this study is to investigate, whether cardiac surgery patients have a reduced postoperative chest tube output and transfusion need when using a point-of-care guided transfusion algorithm compared to standard of care transfusion protocols .

Inclusion Criteria:

• elective cardiac surgery patient requiring cardiopulmonary bypass
• moderate or high transfusion risk
• signed informed consent

Exclusion Criteria:

• age <18 or >80 years
• known hemophilia
• known thrombophilia
• known thrombocytopathy
• hereditary or acquired coagulation disorder
• active endocarditis
• ejection fraction <30%
• BSA < 1.8 sqm
• planned aortic arch surgery
• preoperative thrombocytopenia <150/nl
• underlying hemostaseological disease
• preoperative anemia
• liver cirrhosis Child B or higher
• preoperative creatinine > 2mg/dl
• terminal renal insufficiency requiring dialysis
• vitamin k antagonists during 5 days prior to surgery
• pregnant or breast-feeding women
• known allergy against allogeneic blood products or coagulation factors
• refusal of blood transfusions
• any concomitant investigational agent or participation in another trial