Blood Transfusion; HemoglobinemiaNCT03138200
The Role of Central Venous Oxygen Saturation (ScvO2) as an Indicator of Blood Transfusion in the Critically Ill
A study testing Blood transfusion in people with Blood Transfusion; Hemoglobinemia and Hypoxia, run by Szeged University at 2 sites in Hungary.
Trial summary
Transfusion of red blood cells is an everyday practice in critical care with the primary aim of restoring adequate tissue oxygenation. However, blood transfusion may also be harmful and costly, therefore a so called restrictive transfusion regime has been suggested by recent guidelines. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Transfusion; Hemoglobinemia, Hypoxia, Anemia
- What is being tested?
- Blood transfusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 2 sitesHungary
- Study dates
- 8 Mar 2017to 1 Mar 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (>18 y)
- Critically ill anemic but hemodynamically stable patients treated on the ICU in whom transfusion is considered by the attending physician
- Routine ICU monitoring: invasive blood pressure, CVC, hourly urine output
- Anemia is defined as Hb<100 g/L
- Hemodynamic stability is defined as:
- heart rate (HR)<100/min,
Show all 11Show fewer
- mean arterial pressure (MAP)>60 mmHg
- no or "minimal" requirement of noradrenaline (NA): compensation for sedation not exceeding 5 µg/min
- stable homeostasis:
- pH: 7.30-7.45 ii. HCO3 > 20 mmol/L iii. lactate < 2 mmol/L e. normal hourly urine output for the last 2 hours not facilitated by diuretics: >0.5ml/kg/h
- Central venous catheter in situ (position in the v. cava superior confirmed by chest x-ray)
Who cannot join
- Pregnancy
- Head injury requiring ICP monitoring guided control of ICP
- Shock of any origin
- Patients with heart failure
- Patients with renal failure
Trial locations and contacts
2 sites in 1 country.
Hungary2 sites, 1 recruiting
- Active, not recruiting
Department of Anaesthesia and Intensive Care, Medical Centre, Hungarian Defence Force
Budapest, 1134
- Recruiting
Department of Anaesthesiology and Intensive Therapy
Szeged, Csongrád megye, 6725
Petra Dalmann, +36 62 - 545 168, office.aiti@med.u-szeged.hu
About this study
Transfusion of red blood cells is an everyday practice in critical care with the primary aim of restoring adequate tissue oxygenation. However, blood transfusion may also be harmful and costly, therefore a so called restrictive transfusion regime has been suggested by recent guidelines. These transfusion guidelines consider certain levels of hemoglobin as transfusion trigger, which on its own gives little information if any about the balance between oxygen delivery (DO2) and consumption (VO2). Hence, there is a clear need for additional physiologic transfusion trigger values. One of the potentially useful and easily obtainable physiological parameters is the central venous oxygen saturation (ScvO2), which has been shown to be a potential transfusion trigger value in hemodynamically stable but anemic patients. However, the role of ScvO2 as a transfusion trigger value was examined only in a retrospective observational study and in animal experiment.
The normal value of ScvO2 in a resting adult at rest is around 70-75%, which is the product of the VO2 and DO2 relationship. Low ScvO2 usually indicates inadequate DO2. It was found in an observational study that if ScvO2>70% before transfusion due to transfusion only the value of hemoglobin increased but the value of ScvO2 did not change. This finding indicates that the DO2 may have been adequate in spite of the low hemoglobin value and the transfusion may have been unnecessary. In one of their recent animal experiments, the investigators reported that in an isovolemic-anemia model the value of ScvO2<70% was only reached when the value of hemoglobin was far less, 59 g/L, than the recommended lowest value of 70g/L as transfusion trigger by guidelines.
Read more
Despite the pathophysiological rationale and the encouraging results of retrospective studies and animal experiments, prospective randomized trials in order to test the effects of an ScvO2-assisted transfusion protocol are yet to be performed.
The aim of this study is to investigate the effects of an ScvO2-assisted transfusion protocol as compared to the guideline-based, hemoglobin levels guided transfusion practice.
- Conditions
- Blood Transfusion; Hemoglobinemia, Hypoxia, Anemia
- Being tested
- Blood transfusion
- Keywords
- Transfusion, ScvO2, Hemoglobin
- Medical subject headings
- Hypoxia, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood transfusionBiological
Blood transfusion is a safe, routine procedure in which blood is given to a patient through an intravenous cannula inserted into one of the patient's veins.
| Study group | Role | What they receive |
|---|---|---|
| Blood transfusion based on central venous oxygen saturation | Other | Not described Receives: Biological: Blood transfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of number of transfuion events in the two groups
Comparison of how many tranfusions were performed based on ScvO2 to conventional, hemoglobin based transfusion.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2017
- Study start8 Mar 2017
- Primary completion1 Mar 2019 (estimated)
- Study completion1 Mar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Blood Transfusion; HemoglobinemiaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Szeged University
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Centre Hungarian Defence Forces
- Responsible party
- Principal investigator, Zsolt Molnár, MD, PhD, DEAA, Szeged University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03138200
- Sponsor's protocol ID
- ScvO2 transfusion
- Status last verified
- Apr 2017
- First submitted
- 8 Mar 2017
- Last updated
- 3 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Blood Observational Study Investigators of ANZICS-Clinical Trials Group; Westbrook A, Pettila V, Nichol A, Bailey MJ, Syres G, Murray L, Bellomo R, Wood E, Phillips LE, Street A, French C, Orford N, Santamaria J, Cooper DJ. Transfusion practice and guidelines in Australian and New Zealand intensive care units. Intensive Care Med. 2010 Jul;36(7):1138-46. doi: 10.1007/s00134-010-1867-8. Epub 2010 May 4.
PubMed 20440603Vallet B, Robin E, Lebuffe G. Venous oxygen saturation as a physiologic transfusion trigger. Crit Care. 2010;14(2):213. doi: 10.1186/cc8854. Epub 2010 Mar 9.
PubMed 20236457Adamczyk S, Robin E, Barreau O, Fleyfel M, Tavernier B, Lebuffe G, Vallet B. [Contribution of central venous oxygen saturation in postoperative blood transfusion decision]. Ann Fr Anesth Reanim. 2009 Jun;28(6):522-30. doi: 10.1016/j.annfar.2009.03.013. Epub 2009 May 20. French.
PubMed 19467825Kocsi S, Demeter G, Fogas J, Erces D, Kaszaki J, Molnar Z. Central venous oxygen saturation is a good indicator of altered oxygen balance in isovolemic anemia. Acta Anaesthesiol Scand. 2012 Mar;56(3):291-7. doi: 10.1111/j.1399-6576.2011.02622.x. Epub 2012 Jan 19.
PubMed 22260228
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Central Venous Oxygen Saturation (ScvO2) as an Indicator of Blood Transfusion in the Critically Ill
- ClinicalTrials.gov ID
- NCT03138200
- Acronym / sponsor ID
- ScvO2 transfusion
- Conditions
- Blood Transfusion; Hemoglobinemia, Hypoxia, Anemia
- Keywords
- Transfusion, ScvO2, Hemoglobin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Szeged UniversityUniversity, hospital or other
- Collaborators
- Medical Centre Hungarian Defence Forces
- Study start
- 8 Mar 2017 (actual)
- Primary completion
- 1 Mar 2019 (estimated)
- Study completion
- 1 Mar 2019 (estimated)
- First posted
- 3 May 2017 (actual)
- 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.
Transfusion of red blood cells is an everyday practice in critical care with the primary aim of restoring adequate tissue oxygenation. However, blood transfusion may also be harmful and costly, therefore a so called restrictive transfusion regime has been suggested by recent guidelines. These transfusion guidelines consider certain levels of hemoglobin as transfusion trigger, which on its own gives little information if any about the balance between oxygen delivery (DO2) and consumption (VO2). Hence, there is a clear need for additional physiologic transfusion trigger values. One of the potentially useful and easily obtainable physiological parameters is the central venous oxygen saturation (ScvO2), which has been shown to be a potential transfusion trigger value in hemodynamically stable but anemic patients. However, the role of ScvO2 as a transfusion trigger value was examined only in a retrospective observational study and in animal experiment.
The normal value of ScvO2 in a resting adult at rest is around 70-75%, which is the product of the VO2 and DO2 relationship. Low ScvO2 usually indicates inadequate DO2. It was found in an observational study that if ScvO2>70% before transfusion due to transfusion only the value of hemoglobin increased but the value of ScvO2 did not change. This finding indicates that the DO2 may have been adequate in spite of the low hemoglobin value and the transfusion may have been unnecessary. In one of their recent animal experiments, the investigators reported that in an isovolemic-anemia model the value of ScvO2<70% was only reached when the value of hemoglobin was far less, 59 g/L, than the recommended lowest value of 70g/L as transfusion trigger by guidelines.
Despite the pathophysiological rationale and the encouraging results of retrospective studies and animal experiments, prospective randomized trials in order to test the effects of an ScvO2-assisted transfusion protocol are yet to be performed.
The aim of this study is to investigate the effects of an ScvO2-assisted transfusion protocol as compared to the guideline-based, hemoglobin levels guided transfusion practice.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Blood transfusion based on central venous oxygen saturation | Other | Biological: Blood transfusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Adult (>18 y)
- Critically ill anemic but hemodynamically stable patients treated on the ICU in whom transfusion is considered by the attending physician
- Routine ICU monitoring: invasive blood pressure, CVC, hourly urine output
- Anemia is defined as Hb<100 g/L
- Hemodynamic stability is defined as:
Key exclusion criteria (5 listed)
- Pregnancy
- Head injury requiring ICP monitoring guided control of ICP
- Shock of any origin
- Patients with heart failure
- Patients with renal failure
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 |
|---|---|---|
| Blood transfusionBlood transfusion is a safe, routine procedure in which blood is given to a patient through an intravenous cannula inserted into one of the patient's veins. | Biological | Blood transfusion based on central venous oxygen saturation |
Primary outcome
Comparison of number of transfuion events in the two groups
Time frame: 2 years
Comparison of how many tranfusions were performed based on ScvO2 to conventional, hemoglobin based transfusion.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2017.
- Background: PubMed 20440603Blood Observational Study Investigators of ANZICS-Clinical Trials Group; Westbrook A, Pettila V, Nichol A, Bailey MJ, Syres G, Murray L, Bellomo R, Wood E, Phillips LE, Street A, French C, Orford N, Santamaria J, Cooper DJ. Transfusion practice and guidelines in Australian and New Zealand intensive care units. Intensive Care Med. 2010 Jul;36(7):1138-46. doi: 10.1007/s00134-010-1867-8. Epub 2010 May 4.
- Background: PubMed 20236457Vallet B, Robin E, Lebuffe G. Venous oxygen saturation as a physiologic transfusion trigger. Crit Care. 2010;14(2):213. doi: 10.1186/cc8854. Epub 2010 Mar 9.
- Background: PubMed 19467825Adamczyk S, Robin E, Barreau O, Fleyfel M, Tavernier B, Lebuffe G, Vallet B. [Contribution of central venous oxygen saturation in postoperative blood transfusion decision]. Ann Fr Anesth Reanim. 2009 Jun;28(6):522-30. doi: 10.1016/j.annfar.2009.03.013. Epub 2009 May 20. French.
- Background: PubMed 22260228Kocsi S, Demeter G, Fogas J, Erces D, Kaszaki J, Molnar Z. Central venous oxygen saturation is a good indicator of altered oxygen balance in isovolemic anemia. Acta Anaesthesiol Scand. 2012 Mar;56(3):291-7. doi: 10.1111/j.1399-6576.2011.02622.x. Epub 2012 Jan 19.
- Individual participant dataSharing planned: Undecided
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.
Department of Anaesthesiology and Intensive Therapy
Szeged, Hungary
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood transfusion in people with Blood Transfusion; Hemoglobinemia and Hypoxia, run by Szeged University at 2 sites in Hungary.
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 11 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 3 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Hungary. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of number of transfuion events in the two groups (time frame: 2 years). 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 NCT03138200, which also lists 4 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 3 May 2017.