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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
Sponsor:
Information provided by (Responsible Party):
STAVROULA GEORGOPOULOU, Larissa University Hospital

Brief Summary:
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 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

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 : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
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

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U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. The number of packed red cell units transfused intra-operatively [ Time Frame: one year ]

Secondary Outcome Measures :
  1. The INVOS values electronically and continuously [ Time Frame: one year ]
  2. The volume of any kind of intravenous fluids administered to the patient [ Time Frame: one year ]
  3. The volume of urine output from the initiation to termination of CPB and to the end [ Time Frame: one year ]
  4. The hematocrit values at certain timeframes [ Time Frame: one year ]


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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
Greece
Larissa University Hospital
Larissa, Thessalia, Greece
Sponsors and Collaborators
Larissa University Hospital
Investigators
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