Clinical Trials Directory

Trials / Completed

CompletedNCT00879463

Brain Tissue Oxygen Saturation and Blood Transfusion in Cardiac Surgery

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
150 (actual)
Sponsor
Larissa University Hospital · Academic / Other
Sex
All
Age
Healthy volunteers
Not accepted

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).

Conditions

Interventions

TypeNameDescription
PROCEDUREBrain tissue oxygen saturation monitoringBrain tissue oxygen saturation monitoring with infrared spectrophotoscopy
PROCEDURETransfusion according to the anesthesiologist's judgementTransfusion if hemoglobin is between 5.5-7 mg/dl

Timeline

Start date
2009-06-01
Primary completion
2010-12-01
Completion
2012-04-01
First posted
2009-04-10
Last updated
2012-07-25

Locations

1 site across 1 country: Greece

Source: ClinicalTrials.gov record NCT00879463. Inclusion in this directory is not an endorsement.