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

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.

Study Overview

• Status: Completed
• Conditions: Cardiac Surgery; Blood Transfusion
• Intervention / Treatment: Procedure: Brain tissue oxygen saturation monitoring; Procedure: Transfusion according to the anesthesiologist's judgement

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
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Thessalia
    • Larissa, Thessalia, Greece
      • Larissa University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The number of packed red cell units transfused intra-operatively	one year

Secondary Outcome Measures

Outcome Measure	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	one year
The hematocrit values at certain timeframes	one year

Collaborators and Investigators

• Sponsor: Larissa University Hospital
• 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: June 1, 2009
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): April 1, 2012

Study Registration Dates

• First Submitted: April 9, 2009
• First Submitted That Met QC Criteria: April 9, 2009
• First Posted (Estimate): April 10, 2009

Study Record Updates

• Last Update Posted (Estimate): July 25, 2012
• Last Update Submitted That Met QC Criteria: July 24, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Keywords: Blood transfusion in cardiac operations under CPB; Infrared spectrophotoscopy
• Other Study ID Numbers: UH 1969 TT