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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00879463
Acronym
INVOS
Enrollment
150
Registered
2009-04-10
Start date
2009-06-30
Completion date
2012-04-30
Last updated
2012-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Transfusion, Cardiac Surgery

Keywords

Blood transfusion in cardiac operations under CPB, Infrared spectrophotoscopy

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).

Interventions

PROCEDUREBrain tissue oxygen saturation monitoring

Brain tissue oxygen saturation monitoring with infrared spectrophotoscopy

PROCEDURETransfusion according to the anesthesiologist's judgement

Transfusion if hemoglobin is between 5.5-7 mg/dl

Sponsors

Larissa University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
The number of packed red cell units transfused intra-operativelyone year

Secondary

MeasureTime frame
The INVOS values electronically and continuouslyone year
The volume of any kind of intravenous fluids administered to the patientone year
The volume of urine output from the initiation to termination of CPB and to the endone year
The hematocrit values at certain timeframesone year

Countries

Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026