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Completed

NCT Number: NCT00879463

Brain Tissue Oxygen Saturation and Blood Transfusion in Cardiac Surgery

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Larissa University Hospital

Larissa, Thessaly, Greece

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brain tissue oxygen saturation monitoring

Procedure

Brain tissue oxygen saturation monitoring with infrared spectrophotoscopy

Transfusion according to the anesthesiologist's judgement

Procedure

Transfusion if hemoglobin is between 5.5-7 mg/dl

Primary outcomes

  1. The number of packed red cell units transfused intra-operatively

    Time frame: one year

Secondary outcomes

  1. The INVOS values electronically and continuously

    Time frame: one year

  2. The volume of any kind of intravenous fluids administered to the patient

    Time frame: one year

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

    Time frame: one year

  4. The hematocrit values at certain timeframes

    Time frame: one year

Sponsors and collaborators

Lead sponsor

Larissa University Hospital

Other

Registry information

Official study title

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

Acronym: INVOS

Important dates

Study start
2009
Primary completion
2010
Study completion
2012
First posted
Apr 10, 2009
Registry last updated
Jul 25, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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