Brain Tissue Oxygen Saturation and Blood Transfusion in Cardiac Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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The Impact of Brain Tissue Oxygen Saturation Monitoring in Reducing the Use of Red Blood Cells in Cardiac Surgery

Conditions
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Blood Transfusion, Cardiac Surgery

Intervention / Treatment
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* Procedure: Brain tissue oxygen saturation monitoring
* Procedure: Transfusion according to the anesthesiologist's judgement


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: GROUP A<br>Brain tissue oxygen saturation monitoring | Procedure: Brain tissue oxygen saturation monitoring<br>* Brain tissue oxygen saturation monitoring with infrared spectrophotoscopy<br>|
| Active Comparator: GROUP B<br>CONTROL GROUP | Procedure: Transfusion according to the anesthesiologist's judgement<br>* Transfusion if hemoglobin is between 5.5-7 mg/dl<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of packed red cell units transfused intra-operatively |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The INVOS values electronically and continuously |  | one year | 
| The volume of any kind of intravenous fluids administered to the patient |  | one year | 
| The volume of urine output from the initiation to termination of CPB and to the end |  | one year | 
| The hematocrit values at certain timeframes |  | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Blood transfusion in cardiac operations under CPB, Infrared spectrophotoscopy