Brain Tissue Oxygen Saturation and Blood Transfusion in Cardiac Surgery (INVOS)
The Impact of Brain Tissue Oxygen Saturation Monitoring in Reducing the Use of Red Blood Cells in Cardiac Surgery
Study Overview
Status
Conditions
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).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Thessalia
-
Larissa, Thessalia, Greece
- Larissa University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: GROUP A
Brain tissue oxygen saturation monitoring
|
Brain tissue oxygen saturation monitoring with infrared spectrophotoscopy
|
|
Active Comparator: GROUP B
CONTROL GROUP
|
Transfusion if hemoglobin is between 5.5-7 mg/dl
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
The number of packed red cell units transfused intra-operatively
Time Frame: one year
|
one year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
The INVOS values electronically and continuously
Time Frame: one year
|
one year
|
|
The volume of any kind of intravenous fluids administered to the patient
Time Frame: one year
|
one year
|
|
The volume of urine output from the initiation to termination of CPB and to the end
Time Frame: one year
|
one year
|
|
The hematocrit values at certain timeframes
Time Frame: one year
|
one year
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: GEORGE VRETZAKIS, M.D. PhD, Cardiac Anesthesia Unit, Department of Anesthesiology, University Hospital of Larissa, Greece
- Principal Investigator: STAVROULA GEORGOPOULOU, M.D., 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
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- UH 1969 TT
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