Brain Tissue Oxygen Saturation and Blood Transfusion in Cardiac Surgery

Cardiac Surgery Clinical Trial

— INVOS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00879463
• Other study ID #: UH 1969 TT
• Status: Completed
• Phase: N/A
• First received: April 9, 2009
• Last updated: July 24, 2012
• Start date: June 2009
• Est. completion date: April 2012

Study information

• Verified date: July 2012
• Source: Larissa University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ethics CommitteeGreece: Ministry of Health and WelfareGreece: National Organization of Medicines
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: April 2012
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Blood Transfusion
• Cardiac Surgery

Intervention

Procedure:
• Brain tissue oxygen saturation monitoring
Brain tissue oxygen saturation monitoring with infrared spectrophotoscopy
• Transfusion according to the anesthesiologist's judgement
Transfusion if hemoglobin is between 5.5-7 mg/dl

Locations

Country	Name	City	State
Greece	Larissa University Hospital	Larissa	Thessalia

Sponsors (1)

Lead Sponsor	Collaborator
Larissa University Hospital

Country where clinical trial is conducted

Greece, 

References & Publications (2)

Goodnough LT, Shander A. Evolution in alternatives to blood transfusion. Hematol J. 2003;4(2):87-91. Review. — View Citation

Tinmouth A, Macdougall L, Fergusson D, Amin M, Graham ID, Hebert PC, Wilson K. Reducing the amount of blood transfused: a systematic review of behavioral interventions to change physicians' transfusion practices. Arch Intern Med. 2005 Apr 25;165(8):845-52. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of packed red cell units transfused intra-operatively		one year	Yes
Secondary	The INVOS values electronically and continuously		one year	Yes
Secondary	The volume of any kind of intravenous fluids administered to the patient		one year	Yes
Secondary	The volume of urine output from the initiation to termination of CPB and to the end		one year	Yes
Secondary	The hematocrit values at certain timeframes		one year	Yes