Undergoing Nonemergent Cardiac SurgeryReTSEACSNCT02761564
SvO2 Trigger in Transfusion Strategy After Cardiac Surgery
A study testing Red blood cell tranfusion and ScvO2 measure in people with Undergoing Nonemergent Cardiac Surgery and Central Venous Catheter on the Superior Vena Cava (to Perform ScVO2 Measure), run by University Hospital, Montpellier at 1 site in France.
Trial summary
Current international guidelines suggest a restrictive transfusion strategy, setting that Hb level at 7 g/dl is a reasonable threshold. However, the idea of having only one threshold for all the patients has been challenged by authors, suggesting a more liberal strategy for certain cases. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Undergoing Nonemergent Cardiac Surgery, Central Venous Catheter on the Superior Vena Cava (to Perform ScVO2 Measure), Anemia (<9g/dL) Requiring Blood Transfusion
- What is being tested?
- Red blood cell tranfusion and ScvO2 measure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 6 Oct 2016to 17 Oct 2018
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age over 18 years
- Patients admitted to intensive care after heart surgery
- Anemic patient (Hb < 9 g/dL)
- Patient with a central venous catheter in the territory SVC
Who cannot join
- Patient with acute bleeding defined as a postoperative bleeding over 1000 ml in 12 hours or the need for a recovery operation for hemostasis or the transfusion of blood units over 4
- Patient with severe sepsis or septic shock criteria defined by the Surviving Sepsis compaign
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Restrictive Transfusion Strategy Early After Cardiac Surgery
Current international guidelines suggest a restrictive transfusion strategy, setting that Hb level at 7 g/dl is a reasonable threshold. However, the idea of having only one threshold for all the patients has been challenged by authors, suggesting a more liberal strategy for certain cases. At the moment, there is no other parameter considered accurate enough to be taken into consideration for transfusion strategy management.
This study is to use ScVO2, a current, easily accessible parameter, before blood transfusion in order to stratify its indication after cardiac surgery.
Read more
Monocentric, randomised, single blind study (patient not aware of the group assignments) Patient inclusion will be made in ICU if the physician decides to perform blood transfusion according to standard transfusion strategy to treat a postoperative anemia (Hb<9g/dL).
Every patient will go through randomization to be placed in one of the two groups of the study: either the one whose transfusion strategy is adjusted by the pretransfusion ScvO2 (group ScvO2), or the control group.
Our main objective is to evaluate the impact of a new transfusion strategy founded on guidelines, but provided ScvO2 is less than 65%, on the incidence of red blood cells transfusion for anemia early after cardiac surgery.
Read the detailed description
Currently, the rate of transfusion of cardiac surgery patients is approximately 50%. The decision to transfuse is based on the hemoglobin (Hb), the transfusion threshold from 7 to 9 g / dL seems to be reasonable, based on clinical parameters, as well as patient history, as the degree of coronary stenosis . Several randomized studies have shown that a restrictive transfusion strategy was superior to a liberal strategy.
ScvO2 is a parameter reflecting the balance between transport O2 and O2 in tissue consumption, which Hb is one of the determinants. It requires that a levy on central venous used frequently for such patients. ScvO2 could make better account of the actual tolerance of anemia that the only value of Hb and the patient's clinical characteristics.
We therefore hypothesize that ScvO2 can help with the decision of RBC transfusions after heart surgery.
Primary and secondary endpoints Principal: To assess the value of ScvO2 threshold (65%) in the restrictive transfusion strategy on the incidence of transfusion after cardiac surgery.
secondary:
- Assess the impact of transfusion strategy based on ScvO2 on the number of transfused patients at D28
- Assess the impact of transfusion strategy based on ScvO2 on the number of cells transfused concentrates.
- Assess the impact of transfusion strategy based on ScvO2 on mortality or incidence of disease events such as cardiac complications, renal, respiratory or neurological dysfunction in the immediate aftermath of surgery.
- Conditions
- Undergoing Nonemergent Cardiac Surgery, Central Venous Catheter on the Superior Vena Cava (to Perform ScVO2 Measure), Anemia (<9g/dL) Requiring Blood Transfusion, Hemodynamic and Respiratory Stability, Bleeding Graded as Insignificant, Mild, Moderate of Universal Definition of Perioperative Bleeding
- Being tested
- Red blood cell tranfusion, ScvO2 measure
- Keywords
- Cardiac surgery, Blood transfusion, ScvO2
- Medical subject headings
- Anemia, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Red blood cell tranfusionOther
Red blood cell transfusion according to transfusion guidelines.
ScvO2 measureOther
ScvO2 (oximetry) is measured at the distal lumen of the central venous catheter placed in the superior vena cava. Transfusion is performed if ScvO2 is inferior or equal to 65%.
| Study group | Role | What they receive |
|---|---|---|
| ScVO2 group | Experimental | Anemia (<9g/dL) requiring blood transfusion Measure of ScvO2 : ScVO2 is measured using the central venous catheter placed in the superior vena cava. Transfusion is performed if the ScVO2 is inferior or equal to 65%. Receives: Other: ScvO2 measure |
| Control group | Other | Anemia (<9g/dL) requiring blood transfusion : Transfusion is performed following national guidelines for red blood cell transfusion Receives: Other: Red blood cell tranfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients transfused
Number of patients transfused during ICU stay
Measured: Between 1 and 28 days (ICU stay)
Secondary outcomes (3)
Number of patients transfused
Number of patients transfused on day 28
Measured: Day 28
Number of blood units transfused in ICU
Number of blood units transfused during ICU stay
Measured: Between 1 and 28 days (ICU stay)
Number of blood units transfused on day 28
Number of blood units transfused
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2016 (estimated)
- Study start6 Oct 2016
- Primary completion17 Sep 2018
- Study completion17 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Undergoing Nonemergent Cardiac SurgeryStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Norddine ZEOURAL, MD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02761564
- Sponsor's protocol ID
- 9655
- Acronym
- ReTSEACS
- Status last verified
- May 2016
- First submitted
- 28 Apr 2016
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Zeroual N, Blin C, Saour M, David H, Aouinti S, Picot MC, Colson PH, Gaudard P. Restrictive Transfusion Strategy after Cardiac Surgery. Anesthesiology. 2021 Mar 1;134(3):370-380. doi: 10.1097/ALN.0000000000003682.
PubMed 33475735
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Restrictive Transfusion Strategy Early After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT02761564
- Acronym / sponsor ID
- ReTSEACS / 9655
- Conditions
- Undergoing Nonemergent Cardiac Surgery, Central Venous Catheter on the Superior Vena Cava (to Perform ScVO2 Measure), Anemia (<9g/dL) Requiring Blood Transfusion, Hemodynamic and Respiratory Stability, Bleeding Graded as Insignificant, Mild, Moderate of Universal Definition of Perioperative Bleeding
- Keywords
- Cardiac surgery, Blood transfusion, ScvO2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 6 Oct 2016 (actual)
- Primary completion
- 17 Sep 2018 (actual)
- Study completion
- 17 Oct 2018 (actual)
- First posted
- 4 May 2016 (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.
Current international guidelines suggest a restrictive transfusion strategy, setting that Hb level at 7 g/dl is a reasonable threshold. However, the idea of having only one threshold for all the patients has been challenged by authors, suggesting a more liberal strategy for certain cases. At the moment, there is no other parameter considered accurate enough to be taken into consideration for transfusion strategy management.
This study is to use ScVO2, a current, easily accessible parameter, before blood transfusion in order to stratify its indication after cardiac surgery.
Monocentric, randomised, single blind study (patient not aware of the group assignments) Patient inclusion will be made in ICU if the physician decides to perform blood transfusion according to standard transfusion strategy to treat a postoperative anemia (Hb<9g/dL).
Every patient will go through randomization to be placed in one of the two groups of the study: either the one whose transfusion strategy is adjusted by the pretransfusion ScvO2 (group ScvO2), or the control group.
Our main objective is to evaluate the impact of a new transfusion strategy founded on guidelines, but provided ScvO2 is less than 65%, on the incidence of red blood cells transfusion for anemia early after cardiac surgery.
Detailed description
Currently, the rate of transfusion of cardiac surgery patients is approximately 50%. The decision to transfuse is based on the hemoglobin (Hb), the transfusion threshold from 7 to 9 g / dL seems to be reasonable, based on clinical parameters, as well as patient history, as the degree of coronary stenosis . Several randomized studies have shown that a restrictive transfusion strategy was superior to a liberal strategy.
ScvO2 is a parameter reflecting the balance between transport O2 and O2 in tissue consumption, which Hb is one of the determinants. It requires that a levy on central venous used frequently for such patients. ScvO2 could make better account of the actual tolerance of anemia that the only value of Hb and the patient's clinical characteristics.
We therefore hypothesize that ScvO2 can help with the decision of RBC transfusions after heart surgery.
Primary and secondary endpoints Principal: To assess the value of ScvO2 threshold (65%) in the restrictive transfusion strategy on the incidence of transfusion after cardiac surgery.
secondary:
- Assess the impact of transfusion strategy based on ScvO2 on the number of transfused patients at D28
- Assess the impact of transfusion strategy based on ScvO2 on the number of cells transfused concentrates.
- Assess the impact of transfusion strategy based on ScvO2 on mortality or incidence of disease events such as cardiac complications, renal, respiratory or neurological dysfunction in the immediate aftermath of surgery.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ScVO2 group | Experimental | Other: ScvO2 measureAnemia (<9g/dL) requiring blood transfusion Measure of ScvO2 : ScVO2 is measured using the central venous catheter placed in the superior vena cava. Transfusion is performed if the ScVO2 is inferior or equal to 65%. |
| Control group | Other | Other: Red blood cell tranfusionAnemia (<9g/dL) requiring blood transfusion : Transfusion is performed following national guidelines for red blood cell transfusion |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age over 18 years
- Patients admitted to intensive care after heart surgery
- Anemic patient (Hb < 9 g/dL)
- Patient with a central venous catheter in the territory SVC
Key exclusion criteria (2 listed)
- Patient with acute bleeding defined as a postoperative bleeding over 1000 ml in 12 hours or the need for a recovery operation for hemostasis or the transfusion of blood units over 4
- Patient with severe sepsis or septic shock criteria defined by the Surviving Sepsis compaign
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 |
|---|---|---|
| Red blood cell tranfusionRed blood cell transfusion according to transfusion guidelines. | Other | Control group |
| ScvO2 measureScvO2 (oximetry) is measured at the distal lumen of the central venous catheter placed in the superior vena cava. Transfusion is performed if ScvO2 is inferior or equal to 65%. | Other | ScVO2 group |
Primary outcome
Number of patients transfused
Time frame: Between 1 and 28 days (ICU stay)
Number of patients transfused during ICU stay
3 secondary outcomes
Number of patients transfused
Time frame: Day 28
Number of blood units transfused in ICU
Time frame: Between 1 and 28 days (ICU stay)
Number of blood units transfused on day 28
Time frame: Day 28
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 12 Jun 2026.
- Results publication: PubMed 33475735Zeroual N, Blin C, Saour M, David H, Aouinti S, Picot MC, Colson PH, Gaudard P. Restrictive Transfusion Strategy after Cardiac Surgery. Anesthesiology. 2021 Mar 1;134(3):370-380. doi: 10.1097/ALN.0000000000003682.
- 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.
Norddine ZEOURAL, MD principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Red blood cell tranfusion and ScvO2 measure in people with Undergoing Nonemergent Cardiac Surgery and Central Venous Catheter on the Superior Vena Cava (to Perform ScVO2 Measure), run by University Hospital, Montpellier at 1 site in France.
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 4 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 12 Jun 2026. 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 France. 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?
Number of patients transfused (time frame: Between 1 and 28 days (ICU stay)). 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 NCT02761564, which also lists 1 linked publication.
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 12 Jun 2026.