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Brain Tissue Oxygen Saturation and Blood Transfusion in Cardiac Surgery

NCT ID: NCT00879463

Last Updated: 2012-07-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2012-04-30

Brief Summary

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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

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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

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Blood Transfusion Cardiac Surgery

Keywords

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Blood transfusion in cardiac operations under CPB Infrared spectrophotoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Caregivers Investigators

Study Groups

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GROUP A

Brain tissue oxygen saturation monitoring

Group Type ACTIVE_COMPARATOR

Brain tissue oxygen saturation monitoring

Intervention Type PROCEDURE

Brain tissue oxygen saturation monitoring with infrared spectrophotoscopy

GROUP B

CONTROL GROUP

Group Type ACTIVE_COMPARATOR

Transfusion according to the anesthesiologist's judgement

Intervention Type PROCEDURE

Transfusion if hemoglobin is between 5.5-7 mg/dl

Interventions

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Brain tissue oxygen saturation monitoring

Brain tissue oxygen saturation monitoring with infrared spectrophotoscopy

Intervention Type PROCEDURE

Transfusion according to the anesthesiologist's judgement

Transfusion if hemoglobin is between 5.5-7 mg/dl

Intervention Type PROCEDURE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Larissa University Hospital

OTHER

Sponsor Role lead

Responsible Party

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STAVROULA GEORGOPOULOU

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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STAVROULA GEORGOPOULOU, M.D.

Role: PRINCIPAL_INVESTIGATOR

Cardiac Anesthesia Unit, Department of Anesthesiology, University Hospital of Larissa, Greece

GEORGE VRETZAKIS, M.D. PhD

Role: STUDY_DIRECTOR

Cardiac Anesthesia Unit, Department of Anesthesiology, University Hospital of Larissa, Greece

KONSTANTINOS STAMOULIS, MD

Role: STUDY_CHAIR

Cardiac Anesthesia Unit, Department of Anesthesiology, University Hospital of Larissa, Greece

ATHINA KLEITSAKI, MD

Role: STUDY_CHAIR

Cardiac Anesthesia Unit, Department of Anesthesiology, University Hospital of Larissa, Greece

Locations

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Larissa University Hospital

Larissa, Thessaly, Greece

Site Status

Countries

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Greece

References

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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.

Reference Type BACKGROUND
PMID: 12750725 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15851633 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23758929 (View on PubMed)

Other Identifiers

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UH 1969 TT

Identifier Type: -

Identifier Source: org_study_id