Brain Tissue Oxygen Saturation and Blood Transfusion in Cardiac Surgery

Not Applicable

Completed

• Conditions: Blood Transfusion; Cardiac Surgery
• Interventions: Procedure: Brain tissue oxygen saturation monitoring; Procedure: Transfusion according to the anesthesiologist's judgement

• Registration Number: NCT00879463
• Lead Sponsor: Larissa University Hospital

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).

Study Timeline

• Study First Submitted: 2009-04-09
• Study First Submitted QC: 2009-04-09
• Study First Posted: 2009-04-10
• Study Start: 2009-06
• Primary Completion: 2010-12
• Study Completion: 2012-04
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-24
• Last Update Posted: 2012-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GROUP A	Brain tissue oxygen saturation monitoring	Brain tissue oxygen saturation monitoring
GROUP B	Transfusion according to the anesthesiologist's judgement	CONTROL GROUP

Primary Outcome Measures

Name	Time	Method
The number of packed red cell units transfused intra-operatively	one year

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Larissa University Hospital; 🇬🇷 Larissa, Thessalia, Greece