NCT00879463

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 9, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 10, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2009

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

July 25, 2012

Status Verified

July 1, 2012

Enrollment Period

1.5 years

First QC Date

April 9, 2009

Last Update Submit

July 24, 2012

Conditions

Blood TransfusionCardiac Surgery

Keywords

Blood transfusion in cardiac operations under CPBInfrared spectrophotoscopy

Outcome Measures

Primary Outcomes (1)

  • The number of packed red cell units transfused intra-operatively

    one year

Secondary Outcomes (4)

  • The INVOS values electronically and continuously

    one year

  • The volume of any kind of intravenous fluids administered to the patient

    one year

  • The volume of urine output from the initiation to termination of CPB and to the end

    one year

  • The hematocrit values at certain timeframes

    one year

Study Arms (2)

GROUP A

ACTIVE COMPARATOR

Brain tissue oxygen saturation monitoring

Procedure: Brain tissue oxygen saturation monitoring

GROUP B

ACTIVE COMPARATOR

CONTROL GROUP

Procedure: Transfusion according to the anesthesiologist's judgement

Interventions

Brain tissue oxygen saturation monitoringPROCEDURE

Brain tissue oxygen saturation monitoring with infrared spectrophotoscopy

GROUP A
Transfusion according to the anesthesiologist's judgementPROCEDURE

Transfusion if hemoglobin is between 5.5-7 mg/dl

GROUP B

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Cardiac operations under cardiopulmonary bypass, consequently (including coronary-aortic bypass graft), valve replacement, surgery of the ascending aorta, combined procedures, redo-operations)

You may not qualify if:

  • Cardiac operations without the aid of extracorporeal circulation (ex. "off-pump" techniques)
  • Emergency operations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Larissa University Hospital

Larissa, Thessaly, Greece

Location

Related Publications (3)

  • 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.

    PMID: 12750725BACKGROUND

  • 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.

    PMID: 15851633BACKGROUND

  • 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.

    PMID: 23758929DERIVED

Study Officials

  • STAVROULA GEORGOPOULOU, M.D.

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

    PRINCIPAL INVESTIGATOR

  • GEORGE VRETZAKIS, M.D. PhD

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

    STUDY DIRECTOR

  • KONSTANTINOS STAMOULIS, MD

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

    STUDY CHAIR

  • ATHINA KLEITSAKI, MD

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

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

April 9, 2009

First Posted

April 10, 2009

Study Start

June 1, 2009

Primary Completion

December 1, 2010

Study Completion

April 1, 2012

Last Updated

July 25, 2012

Record last verified: 2012-07

Locations

GR(1)