Brain Tissue Oxygen Saturation and Blood Transfusion in Cardiac Surgery (INVOS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
STAVROULA GEORGOPOULOU, Larissa University Hospital
ClinicalTrials.gov Identifier:
NCT00879463
First received: April 9, 2009
Last updated: July 24, 2012
Last verified: July 2012
  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

Resource links provided by NLM:


Further study details as provided by Larissa University Hospital:

Primary Outcome Measures:
  • The number of packed red cell units transfused intra-operatively [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 July 24, 2014