Brain Tissue Oxygen Saturation and Blood Transfusion in Cardiac Surgery (INVOS)

• The INVOS values electronically and continuously [ Time Frame: one year ] [ Designated as safety issue: Yes ]
• The volume of any kind of intravenous fluids administered to the patient [ Time Frame: one year ] [ Designated as safety issue: Yes ]
• The volume of urine output from the initiation to termination of CPB and to the end [ Time Frame: one year ] [ Designated as safety issue: Yes ]
• The hematocrit values at certain timeframes [ Time Frame: one year ] [ Designated as safety issue: Yes ]

In cardiac operations under cardiopulmonary bypass(CPB), monitoring of brain tissue oxygen saturation with infrared spectrophotoscopy leads to a reduction of the number of packed red cell(PRC) transfusions during the period of extracorporeal circulation.

The purpose of this study is to investigate whether the use of brain tissue oxygen saturation monitoring will lead to a reduction of the intra-operative use of packed red cell units.

Patients randomly allocated to groups A and B. In group A INVOS monitoring available. In group B, no access to INVOS for the attending anesthesiologist. An "observer" anesthesiologist has access to INVOS and provides information if it is considered necessary.

For BOTH GROUPS:

During CBP and before aortic unclamping, PRC not to be given if hemoglobin is >7g/dl. For values less than 5.5g/dl, one unit of PRC is transfused and the patient is reevaluated. After weaning from CPB and retransfusion of the salvaged shed blood, transfusion when hemoglobin is <8g/dl. During ICU stay, transfusion when hemoglobin is <8g/dl. Between 8-10g/dl evaluation for transfusion in a multimodal manner.

For GROUP A:

As above and during CBP and before aortic unclamping, if hemoglobin is between 5.5-7g/dl, transfusion when INVOS is less than 60%.

For GROUP B:

As above and during CBP and before aortic unclamping, if hemoglobin is between 5.5-7g/dl, decision for transfusion is taken by the attending anesthesiologist (judgment).

• Blood Transfusion
• Cardiac Surgery

• Procedure: Brain tissue oxygen saturation monitoring
  Brain tissue oxygen saturation monitoring with infrared spectrophotoscopy
• Procedure: Transfusion according to the anesthesiologist's judgement
  Transfusion if hemoglobin is between 5.5-7 mg/dl

• Active Comparator: GROUP A
  Brain tissue oxygen saturation monitoring
  Intervention: Procedure: Brain tissue oxygen saturation monitoring
• Active Comparator: GROUP B
  CONTROL GROUP
  Intervention: Procedure: Transfusion according to the anesthesiologist's judgement

• Goodnough LT, Shander A. Evolution in alternatives to blood transfusion. Hematol J. 2003;4(2):87-91. Review. No abstract available.
• Tinmouth A, Macdougall L, Fergusson D, Amin M, Graham ID, Hebert PC, Wilson K. Reducing the amount of blood transfused: a systematic review of behavioral interventions to change physicians' transfusion practices. Arch Intern Med. 2005 Apr 25;165(8):845-52. Review.

Inclusion Criteria:

• Cardiac operations under cardiopulmonary bypass, consequently (including coronary-aortic bypass graft), valve replacement, surgery of the ascending aorta, combined procedures, redo-operations)

Exclusion Criteria:

• Cardiac operations without the aid of extracorporeal circulation (ex. "off-pump" techniques)
• Emergency operations