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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GROUP A | Active Comparator | Brain tissue oxygen saturation monitoring |
|
| GROUP B | Active Comparator | CONTROL GROUP |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brain tissue oxygen saturation monitoring | Procedure | Brain tissue oxygen saturation monitoring with infrared spectrophotoscopy |
|
| Measure | Description | Time Frame |
|---|---|---|
| The number of packed red cell units transfused intra-operatively | one year |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| STAVROULA GEORGOPOULOU, M.D. | Cardiac Anesthesia Unit, Department of Anesthesiology, University Hospital of Larissa, Greece | Principal Investigator |
| GEORGE VRETZAKIS, M.D. PhD | Cardiac Anesthesia Unit, Department of Anesthesiology, University Hospital of Larissa, Greece | Study Director |
| KONSTANTINOS STAMOULIS, MD | Cardiac Anesthesia Unit, Department of Anesthesiology, University Hospital of Larissa, Greece | Study Chair |
| ATHINA KLEITSAKI, MD | Cardiac Anesthesia Unit, Department of Anesthesiology, University Hospital of Larissa, Greece | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Larissa University Hospital | Larissa | Thessaly | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12750725 | Background | Goodnough LT, Shander A. Evolution in alternatives to blood transfusion. Hematol J. 2003;4(2):87-91. doi: 10.1038/sj.thj.6200237. No abstract available. | |
| 15851633 | Background | 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. doi: 10.1001/archinte.165.8.845. |
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| Transfusion according to the anesthesiologist's judgement | Procedure | Transfusion if hemoglobin is between 5.5-7 mg/dl |
|
| one year |
| The hematocrit values at certain timeframes | one year |
| 23758929 | Derived | Vretzakis G, Georgopoulou S, Stamoulis K, Tassoudis V, Mikroulis D, Giannoukas A, Tsilimingas N, Karanikolas M. Monitoring of brain oxygen saturation (INVOS) in a protocol to direct blood transfusions during cardiac surgery: a prospective randomized clinical trial. J Cardiothorac Surg. 2013 Jun 7;8:145. doi: 10.1186/1749-8090-8-145. |