Algorithm-Guided Transfusions in Cardiac Surgery Patients for Reduction of Drainage Blood Losses (HEART-PoC)

• need of allogeneic blood transfusions [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
• course of conventional coagulation parameters (aPTT, TPZ, fibrinogen, FXIII, ACT) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
• duration of mechanical ventilation [ Time Frame: hours (average) ] [ Designated as safety issue: No ]
• incidence of RRT [ Time Frame: during 30 days ] [ Designated as safety issue: No ]
  or until hospital discharge, whatever is earlier

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 .

• Chest Tube Output
• Allogeneic Blood Transfusions

• Other: Point of Care Coagulation Monitoring Guided Transfusion Algorithm
  (thromboelastometry, aggregometry, blood gas analysis)
  Other Name: ROTEM delta, Multiplate, ABL 725
• Other: standard coagulation monitoring guided transfusion algorithm
  aPTT, ACT, platelet count, hemoglobin, fibrinogen

• Experimental: PoC algorithm guided transfusions
  experimental arm
  Intervention: Other: Point of Care Coagulation Monitoring Guided Transfusion Algorithm
• Active Comparator: standard of care transfusions
  control arm
  Intervention: Other: standard coagulation monitoring guided transfusion algorithm

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