Brain Tissue Oxygen Saturation and Blood Transfusion in Cardiac Surgery (INVOS)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Blood Transfusion Cardiac Surgery |
Procedure: Brain tissue oxygen saturation monitoring Procedure: Transfusion according to the anesthesiologist's judgement |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Caregiver, 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 |
- The number of packed red cell units transfused intra-operatively [ Time Frame: one year ] [ Designated as safety issue: Yes ]
- 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 ]
| Enrollment: | 150 |
| Study Start Date: | June 2009 |
| Study Completion Date: | April 2012 |
| Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
CONTROL GROUP
|
Procedure: Transfusion according to the anesthesiologist's judgement
Transfusion if hemoglobin is between 5.5-7 mg/dl
|
Detailed Description:
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).
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Greece | |
| 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 |
More Information
Publications:
| Responsible Party: | STAVROULA GEORGOPOULOU, MD, Larissa University Hospital |
| ClinicalTrials.gov Identifier: | NCT00879463 History of Changes |
| Other Study ID Numbers: | UH 1969 TT |
| Study First Received: | April 9, 2009 |
| Last Updated: | July 24, 2012 |
| Health Authority: | Greece: Ethics Committee Greece: Ministry of Health and Welfare Greece: National Organization of Medicines |
Keywords provided by Larissa University Hospital:
|
Blood transfusion in cardiac operations under CPB Infrared spectrophotoscopy |
ClinicalTrials.gov processed this record on May 16, 2013