Brain Tissue Oxygen Saturation and Blood Transfusion in Cardiac Surgery (INVOS)
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|ClinicalTrials.gov Identifier: NCT00879463|
Recruitment Status : Completed
First Posted : April 10, 2009
Last Update Posted : July 25, 2012
|Condition or disease||Intervention/treatment||Phase|
|Blood Transfusion Cardiac Surgery||Procedure: Brain tissue oxygen saturation monitoring Procedure: Transfusion according to the anesthesiologist's judgement||Not Applicable|
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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Care Provider, Investigator)|
|Primary Purpose:||Supportive Care|
|Official Title:||The Impact of Brain Tissue Oxygen Saturation Monitoring in Reducing the Use of Red Blood Cells in Cardiac Surgery|
|Study Start Date :||June 2009|
|Actual Primary Completion Date :||December 2010|
|Actual Study Completion Date :||April 2012|
Active Comparator: GROUP A
Brain tissue oxygen saturation monitoring
Procedure: Brain tissue oxygen saturation monitoring
Brain tissue oxygen saturation monitoring with infrared spectrophotoscopy
Active Comparator: GROUP B
Procedure: Transfusion according to the anesthesiologist's judgement
Transfusion if hemoglobin is between 5.5-7 mg/dl
- The number of packed red cell units transfused intra-operatively [ Time Frame: one year ]
- The INVOS values electronically and continuously [ Time Frame: one year ]
- The volume of any kind of intravenous fluids administered to the patient [ Time Frame: one year ]
- The volume of urine output from the initiation to termination of CPB and to the end [ Time Frame: one year ]
- The hematocrit values at certain timeframes [ Time Frame: one year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00879463
|Larissa University Hospital|
|Larissa, Thessalia, Greece|
|Principal Investigator:||STAVROULA GEORGOPOULOU, M.D.||Cardiac Anesthesia Unit, Department of Anesthesiology, University Hospital of Larissa, Greece|
|Study Director:||GEORGE VRETZAKIS, M.D. PhD||Cardiac Anesthesia Unit, Department of Anesthesiology, University Hospital of Larissa, Greece|
|Study Chair:||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|