Clinical trial NCT00879463: Brain Tissue Oxygen Saturation and Blood Transfusion in Cardiac Surgery
Official title: The Impact of Brain Tissue Oxygen Saturation Monitoring in Reducing the Use of Red Blood Cells in Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Transfusion
Cardiac Surgery
Keywords: Blood transfusion in cardiac operations under CPB
Infrared spectrophotoscopy
Lead sponsor: Larissa University Hospital
Sponsor class: OTHER
First posted: 2009-04-10
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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).

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

Primary outcomes:
measure: The number of packed red cell units transfused intra-operatively
timeFrame: one year
Secondary outcomes:
measure: The INVOS values electronically and continuously
timeFrame: one year
measure: The volume of any kind of intravenous fluids administered to the patient
timeFrame: one year
measure: The volume of urine output from the initiation to termination of CPB and to the end
timeFrame: one year
measure: The hematocrit values at certain timeframes
timeFrame: one year
Other outcomes:
Locations:
city: Larissa
country: Greece
facility: Larissa University Hospital
state: Thessalia
Study officials:
affiliation: Cardiac Anesthesia Unit, Department of Anesthesiology, University Hospital of Larissa, Greece
name: STAVROULA GEORGOPOULOU, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Cardiac Anesthesia Unit, Department of Anesthesiology, University Hospital of Larissa, Greece
name: GEORGE VRETZAKIS, M.D. PhD
role: STUDY_DIRECTOR
affiliation: Cardiac Anesthesia Unit, Department of Anesthesiology, University Hospital of Larissa, Greece
name: KONSTANTINOS STAMOULIS, MD
role: STUDY_CHAIR
affiliation: Cardiac Anesthesia Unit, Department of Anesthesiology, University Hospital of Larissa, Greece
name: ATHINA KLEITSAKI, MD
role: STUDY_CHAIR
References:
citation: Goodnough LT, Shander A. Evolution in alternatives to blood transfusion. Hematol J. 2003;4(2):87-91. doi: 10.1038/sj.thj.6200237. No abstract available.
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. doi: 10.1001/archinte.165.8.845.
citation: Vretzakis G, Georgopoulou S, Stamoulis K, Tassoudis V, Mikroulis D, Giannoukas A, Tsilimingas N, Karanikolas M. Monitoring of brain oxygen saturation (INVOS) in a protocol to direct blood transfusions during cardiac surgery: a prospective randomized clinical trial. J Cardiothorac Surg. 2013 Jun 7;8:145. doi: 10.1186/1749-8090-8-145.