Blood TransfusionINVOSNCT00879463
Brain Tissue Oxygen Saturation and Blood Transfusion in Cardiac Surgery
A study testing Brain tissue oxygen saturation monitoring and Transfusion according to the anesthesiologist's judgement in people with Blood Transfusion and Cardiac Surgery, run by Larissa University Hospital at 1 site in Greece.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Blood Transfusion, Cardiac Surgery
- What is being tested?
- Brain tissue oxygen saturation monitoring and Transfusion according to the anesthesiologist's judgement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteGreece
- Study dates
- Jun 2009to Apr 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Cardiac operations under cardiopulmonary bypass, consequently (including coronary-aortic bypass graft), valve replacement, surgery of the ascending aorta, combined procedures, redo-operations)
Who cannot join
- Cardiac operations without the aid of extracorporeal circulation (ex. "off-pump" techniques)
- Emergency operations
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Brain Tissue Oxygen Saturation Monitoring in Reducing the Use of Red Blood Cells 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.
Read the 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).
- Conditions
- Blood Transfusion, Cardiac Surgery
- Being tested
- Brain tissue oxygen saturation monitoring, Transfusion according to the anesthesiologist's judgement
- Keywords
- Blood transfusion in cardiac operations under CPB, Infrared spectrophotoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain tissue oxygen saturation monitoringProcedure or surgery
Brain tissue oxygen saturation monitoring with infrared spectrophotoscopy
Transfusion according to the anesthesiologist's judgementProcedure or surgery
Transfusion if hemoglobin is between 5.5-7 mg/dl
| Study group | Role | What they receive |
|---|---|---|
| GROUP A | Active comparator | Brain tissue oxygen saturation monitoring Receives: Procedure: Brain tissue oxygen saturation monitoring |
| GROUP B | Active comparator | CONTROL GROUP Receives: Procedure: Transfusion according to the anesthesiologist's judgement |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of packed red cell units transfused intra-operatively
Measured: one year
Secondary outcomes (4)
The INVOS values electronically and continuously
Measured: one year
The volume of any kind of intravenous fluids administered to the patient
Measured: one year
The volume of urine output from the initiation to termination of CPB and to the end
Measured: one year
The hematocrit values at certain timeframes
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2009 (estimated)
- Study startJun 2009
- Primary completionDec 2010
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Blood TransfusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Larissa University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, STAVROULA GEORGOPOULOU, Larissa University Hospital
- Investigators
- STAVROULA GEORGOPOULOU, M.D., Principal investigator, Cardiac Anesthesia Unit, Department of Anesthesiology, University Hospital of Larissa, GreeceGEORGE VRETZAKIS, M.D. PhD, Study director, Cardiac Anesthesia Unit, Department of Anesthesiology, University Hospital of Larissa, GreeceKONSTANTINOS STAMOULIS, MD, Study chair, Cardiac Anesthesia Unit, Department of Anesthesiology, University Hospital of Larissa, GreeceATHINA KLEITSAKI, MD, Study chair, Cardiac Anesthesia Unit, Department of Anesthesiology, University Hospital of Larissa, Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00879463
- Sponsor's protocol ID
- UH 1969 TT
- Acronym
- INVOS
- Status last verified
- Jul 2012
- First submitted
- 9 Apr 2009
- Last updated
- 25 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 12750725Tinmouth 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.
PubMed 15851633Vretzakis 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.
PubMed 23758929
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Brain Tissue Oxygen Saturation Monitoring in Reducing the Use of Red Blood Cells in Cardiac Surgery
- ClinicalTrials.gov ID
- NCT00879463
- Acronym / sponsor ID
- INVOS / UH 1969 TT
- Conditions
- Blood Transfusion, Cardiac Surgery
- Keywords
- Blood transfusion in cardiac operations under CPB, Infrared spectrophotoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Larissa University HospitalUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 10 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GROUP A | Active comparator | Procedure: Brain tissue oxygen saturation monitoringBrain tissue oxygen saturation monitoring |
| GROUP B | Active comparator | Procedure: Transfusion according to the anesthesiologist's judgementCONTROL GROUP |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Cardiac operations under cardiopulmonary bypass, consequently (including coronary-aortic bypass graft), valve replacement, surgery of the ascending aorta, combined procedures, redo-operations)
Key exclusion criteria (2 listed)
- Cardiac operations without the aid of extracorporeal circulation (ex. "off-pump" techniques)
- Emergency operations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brain tissue oxygen saturation monitoringBrain tissue oxygen saturation monitoring with infrared spectrophotoscopy | Procedure or surgery | GROUP A |
| Transfusion according to the anesthesiologist's judgementTransfusion if hemoglobin is between 5.5-7 mg/dl | Procedure or surgery | GROUP B |
Primary outcome
The number of packed red cell units transfused intra-operatively
Time frame: one year
4 secondary outcomes
The INVOS values electronically and continuously
Time frame: one year
The volume of any kind of intravenous fluids administered to the patient
Time frame: one year
The volume of urine output from the initiation to termination of CPB and to the end
Time frame: one year
The hematocrit values at certain timeframes
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2012.
- Background: PubMed 12750725Goodnough 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.
- Background: PubMed 15851633Tinmouth 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.
- Derived from this study: PubMed 23758929Vretzakis 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
STAVROULA GEORGOPOULOU, M.D. principal investigator
Cardiac Anesthesia Unit, Department of Anesthesiology, University Hospital of Larissa, Greece
GEORGE VRETZAKIS, M.D. PhD study director
Cardiac Anesthesia Unit, Department of Anesthesiology, University Hospital of Larissa, Greece
KONSTANTINOS STAMOULIS, MD study chair
Cardiac Anesthesia Unit, Department of Anesthesiology, University Hospital of Larissa, Greece
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brain tissue oxygen saturation monitoring and Transfusion according to the anesthesiologist's judgement in people with Blood Transfusion and Cardiac Surgery, run by Larissa University Hospital at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of packed red cell units transfused intra-operatively (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00879463, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2012.