Cardiac SurgeryPITTNCT02963883
Erythrocyte Transfusion Based on the Measurement of Central Venous Oxygen Saturation in Postoperative Cardiac Surgery
A study of Cardiac Surgery, run by Centre Hospitalier Universitaire, Amiens at 2 sites in France.
Trial summary
Postoperative erythrocytes transfusion is associated with morbidity and excess mortality, which should lead to ask the indication for RBC transfusions only on metabolic needs. Currently, the majority of studies used to put hemoglobin values indicating red cell transfusions. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cardiac Surgery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 2 sitesFrance
- Study dates
- Dec 2016to 28 May 2020
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient ≥ 18 years
- programmed cardiac surgery
- Central venous catheter placed in territory SVC
- Affiliation to a social security system
- Hemoglobin <9 g / dL (transfusion threshold retained by the recommendations the HAS in November 2014 for perioperative patients with cardiovascular antecedents)
Who cannot join
- Patient minor or under court protection
- Pregnant or lactating women
- severe acute hemorrhagic syndrome (defined by bleeding rate greater than 1.5 ml / kg / hour for 6 consecutive hours and / or surgical revision within the first 24 postoperative hours)
- Installation of an external or internal circulatory support
- emergency surgery (<24 hours from admission)
- Complex Aortic Surgery
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- Sepsis
- Patient Refusal of transfusion (religious belief)
- Patient under guardianship
- Renal failure with dialysis treatment
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Erythrocyte Transfusion Based on the Measurement of Central Venous Oxygen Saturation in Postoperative Cardiac Surgery: a Bicentric, Prospective Randomized Study
Postoperative erythrocytes transfusion is associated with morbidity and excess mortality, which should lead to ask the indication for RBC transfusions only on metabolic needs. Currently, the majority of studies used to put hemoglobin values indicating red cell transfusions. Two observational studies have confirmed that a transfusion strategy based on a metabolic index (ScvO2) individual was accompanied by a different transfusion strategy than using the hemoglobin threshold values. We propose to conduct the first randomized multicenter study to evaluate erythrocyte transfusion strategy in postoperative cardiac surgery using the ScvO2 each patient versus a threshold value usually recommended for all patients.
Read the detailed description
Postoperative erythrocytes transfusion is associated with morbidity and excess mortality, which should lead to ask the indication for RBC transfusions only on metabolic needs. Currently, the majority of studies used to put hemoglobin values indicating red cell transfusions. Two observational studies have confirmed that a transfusion strategy based on a metabolic index (ScvO2) individual was accompanied by a different transfusion strategy than using the hemoglobin threshold values. We propose to conduct the first randomized multicenter study to evaluate erythrocyte transfusion strategy in postoperative cardiac surgery using the ScvO2 each patient versus a threshold value usually recommended for all patients.
- Conditions
- Cardiac Surgery
- Being tested
- SVO2 group / control group
- Keywords
- ScVO2, Post operative red cell transfusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SVO2 group / control groupOther
| Study group | Role | What they receive |
|---|---|---|
| SVO2 group | Experimental | After optimization of oxygenation and blood volume, concentrate transfusion (s) of red blood cells by the individual value of ScvO2, whose value must be greater than 70% after elimination of hypovolemia, hypotension or hypoxemia. Receives: Other: SVO2 group / control group |
| control group | Active comparator | After optimization of oxygenation and blood volume, concentrate transfusion (s) of red blood cells based on the hemoglobin values, as recommended by the National Health Authority for Anesthesiology, Surgery, Emergency (November 2014 ): transfusion threshold of <9 g / dl for patients with cardiovascular antecedents. Receives: Other: SVO2 group / control group |
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 at least one red blood cell concentrate in postoperative cardiac surgery for the ScvO2 group compared to the control group
Measured: 15 dys
Secondary outcomes (19)
acute pulmonary edema due to the overload
acute pulmonary edema due to overload or TACO, defined as acute pulmonary edema overload confirmed by clinical examination and echocardiography and leading to medical treatment
Measured: 15 days
lesional pulmonary edema or TRALI,
lesional pulmonary edema or TRALIassociating acute respiratory distress within 6 hours of transfusion, bilateral infiltrates on chest radiograph, but without respiratory or elevated left ventricular load conditions precedent to echocardiography, and possibly confirmed by tests biological HLA
Measured: 6 h
myocardial infarction
myocardial infarction, defined by elevated serum troponin dosing greater than 10 times the 99th percentile associated with electrocardioscopic changes (appearance of new Q waves or left bundle branch block), ultrasound (appearance of segmental disorder myocardial kinetics) or angiographic (occlusion of a coronary artery or bypass surgery), as defined by the European society of cardiology in 2012,
Measured: 15 days
stroke
stroke, defined by a computed tomography documentation
Measured: 15 days
acute renal failure,
acute renal failure, defined as an increase of at least 50% and / or 26.5 micromol / l of postoperative serum creatinine with respect to the preoperative baseline value and / or urine output less than 0.5 mL / kg / hr about 6 hours (definition of the international society of nephrology KDIGO)
Measured: 15 days
immunological complications including allo-immunization
immunological complications including allo-immunization, immunological incompatibility and hemolytic accidents involving clinical symptoms (chills, fever, back pain), increased serum bilirubin, decreased the haptoglobinemy the positivization direct antiglobulin test ( DAT), or even looking for irregular antibodies as well as disseminated intravascular coagulation, renal failure, anuria or death in case of conflict in the ABO system,
Measured: 15 days
allergic complications including anaphylactic shock
allergic complications including anaphylactic shock involving care in intensive care with intravenous injection of adrenaline, vis-à-vis precautions subsequent transfusions and biological investigations and immediate allergy and distance
Measured: 15 days
infectious complications
infectious complications, including bacterial infections, viral, parasitic, including by poorly known or emerging agents
Measured: 15 days
metabolic complications including febrile non-haemolytic reactions
metabolic complications including febrile non-haemolytic reactions, haemosiderosis and massive transfusion syndrome with hypocalcemia, acid-base imbalance, hyperkalemia, hemostasis disorders and hypothermia
Measured: 15 days
lactate Rate
Measured: 15 days
central venous O2 saturation (SVO2)
Measured: 15 days
SOFA score (sepsis organ failure assessment)
Measured: 15 days
BNP Rate
Measured: 15 days
Death
Measured: 15 days
Cost reduction of transfusion
Cost reduction of transfusion support by reducing the number of PRBC transfusions, including costs related to medical and nursing time, biological examinations pre and post-transfusion, and packed red blood cells.
Measured: 15 days
Rate of lactate
Rate of lactate
Measured: 15 days
central venous O2 saturation (SVO2)
central venous O2 saturation (SVO2)
Measured: 15 days
SOFA score (sepsis organ failure assessment)
SOFA score (sepsis organ failure assessment)
Measured: 15 days
Rate BNP
Rate BNP
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2016 (estimated)
- Study startDec 2016
- Primary completion28 May 2020
- Study completion28 May 2020
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 Cardiac SurgeryStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Osama Abou Arab, Doctor, Principal investigator, CHU Amiens-Picardie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02963883
- Sponsor's protocol ID
- PI2016_843_0015
- Acronym
- PITT
- Status last verified
- Sep 2025
- First submitted
- 10 Nov 2016
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Fischer MO, Guinot PG, Debroczi S, Huette P, Beyls C, Babatasi G, Bafi K, Guilbart M, Caus T, Lorne E, Dupont H, Hanouz JL, Diouf M, Abou-Arab O. Individualised or liberal red blood cell transfusion after cardiac surgery: a randomised controlled trial. Br J Anaesth. 2022 Jan;128(1):37-44. doi: 10.1016/j.bja.2021.09.037. Epub 2021 Nov 30.
PubMed 34862002
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Erythrocyte Transfusion Based on the Measurement of Central Venous Oxygen Saturation in Postoperative Cardiac Surgery: a Bicentric, Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT02963883
- Acronym / sponsor ID
- PITT / PI2016_843_0015
- Conditions
- Cardiac Surgery
- Keywords
- ScVO2, Post operative red cell transfusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- Dec 2016 (actual)
- Primary completion
- 28 May 2020 (actual)
- Study completion
- 28 May 2020 (actual)
- First posted
- 15 Nov 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.
Postoperative erythrocytes transfusion is associated with morbidity and excess mortality, which should lead to ask the indication for RBC transfusions only on metabolic needs. Currently, the majority of studies used to put hemoglobin values indicating red cell transfusions. Two observational studies have confirmed that a transfusion strategy based on a metabolic index (ScvO2) individual was accompanied by a different transfusion strategy than using the hemoglobin threshold values. We propose to conduct the first randomized multicenter study to evaluate erythrocyte transfusion strategy in postoperative cardiac surgery using the ScvO2 each patient versus a threshold value usually recommended for all patients.
Detailed description
Postoperative erythrocytes transfusion is associated with morbidity and excess mortality, which should lead to ask the indication for RBC transfusions only on metabolic needs. Currently, the majority of studies used to put hemoglobin values indicating red cell transfusions. Two observational studies have confirmed that a transfusion strategy based on a metabolic index (ScvO2) individual was accompanied by a different transfusion strategy than using the hemoglobin threshold values. We propose to conduct the first randomized multicenter study to evaluate erythrocyte transfusion strategy in postoperative cardiac surgery using the ScvO2 each patient versus a threshold value usually recommended for all patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SVO2 group | Experimental | Other: SVO2 group / control groupAfter optimization of oxygenation and blood volume, concentrate transfusion (s) of red blood cells by the individual value of ScvO2, whose value must be greater than 70% after elimination of hypovolemia, hypotension or hypoxemia. |
| control group | Active comparator | Other: SVO2 group / control groupAfter optimization of oxygenation and blood volume, concentrate transfusion (s) of red blood cells based on the hemoglobin values, as recommended by the National Health Authority for Anesthesiology, Surgery, Emergency (November 2014 ): transfusion threshold of <9 g / dl for patients with cardiovascular antecedents. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient ≥ 18 years
- programmed cardiac surgery
- Central venous catheter placed in territory SVC
- Affiliation to a social security system
- Hemoglobin <9 g / dL (transfusion threshold retained by the recommendations the HAS in November 2014 for perioperative patients with cardiovascular antecedents)
Key exclusion criteria (10 listed)
- Patient minor or under court protection
- Pregnant or lactating women
- severe acute hemorrhagic syndrome (defined by bleeding rate greater than 1.5 ml / kg / hour for 6 consecutive hours and / or surgical revision within the first 24 postoperative hours)
- Installation of an external or internal circulatory support
- emergency surgery (<24 hours from admission)
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 |
|---|---|---|
| SVO2 group / control group | Other | SVO2 group, control group |
Primary outcome
Number of patients transfused
Time frame: 15 dys
Number of patients transfused at least one red blood cell concentrate in postoperative cardiac surgery for the ScvO2 group compared to the control group
19 secondary outcomes
acute pulmonary edema due to the overload
Time frame: 15 days
lesional pulmonary edema or TRALI,
Time frame: 6 h
myocardial infarction
Time frame: 15 days
stroke
Time frame: 15 days
acute renal failure,
Time frame: 15 days
immunological complications including allo-immunization
Time frame: 15 days
allergic complications including anaphylactic shock
Time frame: 15 days
infectious complications
Time frame: 15 days
metabolic complications including febrile non-haemolytic reactions
Time frame: 15 days
lactate Rate
Time frame: 15 days
central venous O2 saturation (SVO2)
Time frame: 15 days
SOFA score (sepsis organ failure assessment)
Time frame: 15 days
BNP Rate
Time frame: 15 days
Death
Time frame: 15 days
Cost reduction of transfusion
Time frame: 15 days
Rate of lactate
Time frame: 15 days
central venous O2 saturation (SVO2)
Time frame: 15 days
SOFA score (sepsis organ failure assessment)
Time frame: 15 days
Rate BNP
Time frame: 15 days
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 22 Sep 2025.
- Results publication: PubMed 34862002Fischer MO, Guinot PG, Debroczi S, Huette P, Beyls C, Babatasi G, Bafi K, Guilbart M, Caus T, Lorne E, Dupont H, Hanouz JL, Diouf M, Abou-Arab O. Individualised or liberal red blood cell transfusion after cardiac surgery: a randomised controlled trial. Br J Anaesth. 2022 Jan;128(1):37-44. doi: 10.1016/j.bja.2021.09.037. Epub 2021 Nov 30.
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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.
Osama Abou Arab, Doctor principal investigator
CHU Amiens-Picardie
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Cardiac Surgery, run by Centre Hospitalier Universitaire, Amiens at 2 sites 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 5 inclusion and 10 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 22 Sep 2025. 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 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: 15 dys). 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 NCT02963883, 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 22 Sep 2025.