Skip to main content
Clinical Trials/NCT00879463
NCT00879463
Completed
Not Applicable

The Impact of Brain Tissue Oxygen Saturation Monitoring in Reducing the Use of Red Blood Cells in Cardiac Surgery

Larissa University Hospital1 site in 1 country150 target enrollmentJune 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Blood Transfusion
Sponsor
Larissa University Hospital
Enrollment
150
Locations
1
Primary Endpoint
The number of packed red cell units transfused intra-operatively
Status
Completed
Last Updated
13 years ago

Overview

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.

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).

Registry
clinicaltrials.gov
Start Date
June 2009
End Date
April 2012
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Larissa University Hospital
Responsible Party
Principal Investigator
Principal Investigator

STAVROULA GEORGOPOULOU

MD

Larissa University Hospital

Eligibility 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

Outcomes

Primary Outcomes

The number of packed red cell units transfused intra-operatively

Time Frame: one year

Secondary Outcomes

  • The volume of any kind of intravenous fluids administered to the patient(one year)
  • The hematocrit values at certain timeframes(one year)
  • The INVOS values electronically and continuously(one year)
  • The volume of urine output from the initiation to termination of CPB and to the end(one year)

Study Sites (1)

Loading locations...

Similar Trials