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Cardiac SurgeryRETSEACSIINCT05740059

Restrictive Transfusion StratEgy Adjusted by SvO2 During Cardiac Surgery

A study testing Adjusted Transfusion in people with Cardiac Surgery and Cardiopulmonary Bypass, run by University Hospital, Montpellier at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of the clinical trial is to evaluate whether a restrictive transfusion strategy adjusted by SvO2 during the perioperative period of cardiac surgery may reduce the incidence of red blood cell transfusion. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Cardiac Surgery, Cardiopulmonary Bypass
What is being tested?
Adjusted Transfusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
676 participants
Where
1 siteFrance
Study dates
14 Mar 2023to 21 Oct 2025
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 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged above 18 years and under 85 years
  • Signed informed consent form from the patient or his/her close relative or surrogate (if present) before inclusion or when possible when the patient has been included in an emergency setting
  • Anaemic (Haemoglobin at inclusion ≤ 13 g/dL)
  • Operated on elective, on-pump cardiac surgery for : Coronary artery bypass graft (CABG); Aortic, mitral or tricuspid valve (replacement or repair); Ascending aorta;Left ventricle assistance device (LVAD)
  • Operated on urgent on-pump cardiac surgery for : CABG;Endocarditis;Aortic dissection; Heart transplantation
  • Subjects must be covered by public health insurance

Who cannot join

  • Patient with no central venous catheter inserted in the superior vena cava
  • Pregnant or breast feeding patient
  • Subject unable to read or/and write
  • Participation in another interventional clinical trial or administration of an unapproved drug within the last 4 weeks before the screening date
  • Medical history of heparin-induced thrombocytopenia contraindicating heparin use during surgery
  • Persons deprived of their liberty by a judicial or administrative decision, persons undergoing psychiatric care and persons admitted to a health or social establishment for purposes other than research

Trial locations and contacts

1 site in 1 country.

France1 site
  • Departement d'anesthésie et réanimation D - Arnaud de Villeneuve

    Montpellier, 34295

Other trials in France

About this study

Official title: Restrictive Transfusion StratEgy Adjusted by SvO2 During Cardiac Surgery: Multicenter, Single-blinded, Randomised Controlled Trial.

The goal of the clinical trial is to evaluate whether a restrictive transfusion strategy adjusted by SvO2 during the perioperative period of cardiac surgery may reduce the incidence of red blood cell transfusion. Adult patients operated on cardiac surgery will be randomly allocated into two groups, one receiving standard restrictive transfusion, the other receiving SvO2 adjusted restrictive transfusion.The proportion of patients transfused will be compared between the 2 groups.

Read the detailed description

Cardiac surgery represents only a small fraction of all surgical procedures, but consumes a significant proportion of the stored red blood cells (RBC), with almost 50% of patients receiving a perioperative transfusion. Since RBC transfusion is associated with an increased risk of morbidity and mortality, blood patient management strategy has been promoted to favour prevention of anaemia, reduction of bleeding and limitation of transfusion. Current guidelines recommend haemoglobin (Hb) threshold as low as 7 g/dL, but still with a wide possible range (7 to 9 g/dl) and suggest that Hb alone may not be the best criteria for triggering transfusion. As Hb is an oxygen carrier, the rationale for RBC transfusion should be to increase tissue oxygen delivery. Central venous oxygen saturation (central SvO2), which is related to the balance between tissue oxygen delivery and consumption, is easily measurable in cardiac surgery. In a previous study, the investigators showed that in anaemic patients having undergone cardiac surgery, restrictive transfusion according to central SvO2 allowed a significant reduction in RBC transfusion incidence in the ICU. The investigators hypothesize that a restrictive transfusion strategy adjusted by SvO2 during all the perioperative period of cardiac surgery may reduce further the incidence of RBC transfusion. Limiting RBC transfusion to patients with a low SvO2 could save unnecessary transfusions, without increasing the anaemia related risk.

Being tested
Adjusted Transfusion
Keywords
Blood transfusion, Cardiac surgery

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Adjusted TransfusionOther

    Patients assigned to the SvO2 group will be transfused if Hb concentration is lower than 9 g/dL and central SvO2 ≤ 65%. Transfusion will be repeated whenever Hb concentration is lower than 9 g/dL and central SvO2 ≤ 65% during surgery and in the ICU (until day 5). Central SvO2 will be measured on a blood sample obtained from the distal lumen of the central venous catheter. Oximetry will be used for measurement with a point-of-care of gas analysis.

Study groups in NCT05740059
Study groupRoleWhat they receive
ControlNo interventionPatients assigned to the Control group will be transfused if hemoglobin (Hb) concentration is lower than 9 g/d.
Adjusted transfusionActive comparatorPatients assigned to the SvO2 group will be transfused if Hb concentration is lower than 9 g/dL and central SvO2 ≤ 65%.
Receives: Other: Adjusted Transfusion

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. RBC transfusion incidence

    Proportion of RBC transfused patients

    Measured: During cardiac surgery and postoperative ICU stay up to postoperative day 5

Secondary outcomes (19)
  1. RBC transfusion incidence during surgery

    Proportion of patients transfused with RBC during surgery

    Measured: During cardiac surgery

  2. RBC units transfused during surgery

    Number of RBC units transfused during surgery

    Measured: During cardiac surgery

  3. RBC transfusion incidence during postoperative ICU stay

    Proportions of patients transfused with RBC during postoperative ICU stay

    Measured: During postoperative ICU stay

  4. RBC units transfused during postoperative ICU stay

    Number of RBC units transfused during postoperative stay in ICU

    Measured: During postoperative ICU stay

  5. RBC transfusion incidence at hospital discharge or day 28

    Proportions of patients transfused with RBC at hospital discharge or day 28

    Measured: From cadiac surgery to hospital discharge or day 28

  6. RBC units transfused at hospital discharge or day 28

    Number of RBC units transfused at hospital discharge or day 28

    Measured: From cardiac surgery to hospital discharge or day 28

  7. Postoperative septic complications

    Proportion of postoperative septic complications

    Measured: From cardiac surgery to hospital discharge or day 28

  8. Postoperative ischemic complications

    Proportion of postoperative ischemic complications (myocardial infarction, stroke, mesenteric)

    Measured: From cardiac surgery to hospital discharge or day 28

  9. Postoperative acute kidney injury

    Proportion postoperative AKI according to Kdigo stages

    Measured: From cardiac surgery to hospital discharge or day 28

  10. Postoperative liver dysfuncion

    Proportion of postoperative increase in binirubin or plasma hepatic enzymes

    Measured: From cardiac surgery to hospital discharge or day 28

  11. Postoperative respiratory failure

    Proportion of postoperative of Pa/Fi<200

    Measured: From cardiac surgery to hospital discharge or day 28

  12. Postoperative low cardiac output syndrome

    Proportion of low cardiac output

    Measured: From cardiac surgery to hospital discharge or day 28

  13. Postoperative arythmias

    Proportion of atrial fibrillation

    Measured: From cardiac surgery to hospital discharge or day 28

  14. Length of ICU stay

    ICU length of stay (number of days)

    Measured: From ICU admission to ICU discharge ofr day 28

  15. Length of hospital stay

    Hospital length of stay (number of days)

    Measured: From ICU admission to hospital discharge or day 28

  16. Postoperative anemia

    Hemoglobin concentration

    Measured: From ICU admission to hospital discharge or day 28

  17. Death

    Proportion of deaths

    Measured: From cardiac surgery to hospital discharge or day 28

  18. Effect of RBC transfusion on Hb

    Hb changes after RBC transfusion

    Measured: During cardiac surgery and postoperative ICU stay up to postoperative day 5

  19. Effect of RBC transfusion on central SvO2

    Central SvO2 changes after RBC transfusion

    Measured: During cardiac surgery and postoperative ICU stay up to postoperative day 5

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Feb 2023
  2. Study start14 Mar 2023
  3. Primary completion15 Oct 2025
  4. Study completion21 Oct 2025

Resources

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
Model description
Multi-center, single-blinded, and randomized controlled trial.
Masking
Single blind
Who is masked
Participant
Enrolment
676 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05740059
Sponsor's protocol ID
RECHMPL21_0529
Acronym
RETSEACSII
Status last verified
Dec 2025
First submitted
6 Feb 2023
Last updated
16 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Bennett-Guerrero E, Zhao Y, O'Brien SM, Ferguson TB Jr, Peterson ED, Gammie JS, Song HK. Variation in use of blood transfusion in coronary artery bypass graft surgery. JAMA. 2010 Oct 13;304(14):1568-75. doi: 10.1001/jama.2010.1406.

    PubMed 20940382
  • Society of Thoracic Surgeons Blood Conservation Guideline Task Force; Ferraris VA, Ferraris SP, Saha SP, Hessel EA 2nd, Haan CK, Royston BD, Bridges CR, Higgins RS, Despotis G, Brown JR; Society of Cardiovascular Anesthesiologists Special Task Force on Blood Transfusion; Spiess BD, Shore-Lesserson L, Stafford-Smith M, Mazer CD, Bennett-Guerrero E, Hill SE, Body S. Perioperative blood transfusion and blood conservation in cardiac surgery: the Society of Thoracic Surgeons and The Society of Cardiovascular Anesthesiologists clinical practice guideline. Ann Thorac Surg. 2007 May;83(5 Suppl):S27-86. doi: 10.1016/j.athoracsur.2007.02.099.

    PubMed 17462454
  • Hajjar LA, Vincent JL, Galas FR, Nakamura RE, Silva CM, Santos MH, Fukushima J, Kalil Filho R, Sierra DB, Lopes NH, Mauad T, Roquim AC, Sundin MR, Leao WC, Almeida JP, Pomerantzeff PM, Dallan LO, Jatene FB, Stolf NA, Auler JO Jr. Transfusion requirements after cardiac surgery: the TRACS randomized controlled trial. JAMA. 2010 Oct 13;304(14):1559-67. doi: 10.1001/jama.2010.1446.

    PubMed 20940381
  • Stover EP, Siegel LC, Parks R, Levin J, Body SC, Maddi R, D'Ambra MN, Mangano DT, Spiess BD. Variability in transfusion practice for coronary artery bypass surgery persists despite national consensus guidelines: a 24-institution study. Institutions of the Multicenter Study of Perioperative Ischemia Research Group. Anesthesiology. 1998 Feb;88(2):327-33. doi: 10.1097/00000542-199802000-00009.

    PubMed 9477051
  • Murphy GJ, Reeves BC, Rogers CA, Rizvi SI, Culliford L, Angelini GD. Increased mortality, postoperative morbidity, and cost after red blood cell transfusion in patients having cardiac surgery. Circulation. 2007 Nov 27;116(22):2544-52. doi: 10.1161/CIRCULATIONAHA.107.698977. Epub 2007 Nov 12.

    PubMed 17998460
  • Koch CG, Li L, Duncan AI, Mihaljevic T, Loop FD, Starr NJ, Blackstone EH. Transfusion in coronary artery bypass grafting is associated with reduced long-term survival. Ann Thorac Surg. 2006 May;81(5):1650-7. doi: 10.1016/j.athoracsur.2005.12.037.

    PubMed 16631651
  • Paone G, Likosky DS, Brewer R, Theurer PF, Bell GF, Cogan CM, Prager RL; Membership of the Michigan Society of Thoracic and Cardiovascular Surgeons. Transfusion of 1 and 2 units of red blood cells is associated with increased morbidity and mortality. Ann Thorac Surg. 2014 Jan;97(1):87-93; discussion 93-4. doi: 10.1016/j.athoracsur.2013.07.020. Epub 2013 Oct 3.

    PubMed 24094521
  • American Society of Anesthesiologists Task Force on Perioperative Blood Management. Practice guidelines for perioperative blood management: an updated report by the American Society of Anesthesiologists Task Force on Perioperative Blood Management*. Anesthesiology. 2015 Feb;122(2):241-75. doi: 10.1097/ALN.0000000000000463. No abstract available.

    PubMed 25545654
  • Society of Thoracic Surgeons Blood Conservation Guideline Task Force; Ferraris VA, Brown JR, Despotis GJ, Hammon JW, Reece TB, Saha SP, Song HK, Clough ER; Society of Cardiovascular Anesthesiologists Special Task Force on Blood Transfusion; Shore-Lesserson LJ, Goodnough LT, Mazer CD, Shander A, Stafford-Smith M, Waters J; International Consortium for Evidence Based Perfusion; Baker RA, Dickinson TA, FitzGerald DJ, Likosky DS, Shann KG. 2011 update to the Society of Thoracic Surgeons and the Society of Cardiovascular Anesthesiologists blood conservation clinical practice guidelines. Ann Thorac Surg. 2011 Mar;91(3):944-82. doi: 10.1016/j.athoracsur.2010.11.078.

    PubMed 21353044
  • Pagano D, Milojevic M, Meesters MI, Benedetto U, Bolliger D, von Heymann C, Jeppsson A, Koster A, Osnabrugge RL, Ranucci M, Ravn HB, Vonk ABA, Wahba A, Boer C. 2017 EACTS/EACTA Guidelines on patient blood management for adult cardiac surgery. Eur J Cardiothorac Surg. 2018 Jan 1;53(1):79-111. doi: 10.1093/ejcts/ezx325. No abstract available.

    PubMed 29029100
  • Mazer CD, Whitlock RP, Fergusson DA, Hall J, Belley-Cote E, Connolly K, Khanykin B, Gregory AJ, de Medicis E, McGuinness S, Royse A, Carrier FM, Young PJ, Villar JC, Grocott HP, Seeberger MD, Fremes S, Lellouche F, Syed S, Byrne K, Bagshaw SM, Hwang NC, Mehta C, Painter TW, Royse C, Verma S, Hare GMT, Cohen A, Thorpe KE, Juni P, Shehata N; TRICS Investigators and Perioperative Anesthesia Clinical Trials Group. Restrictive or Liberal Red-Cell Transfusion for Cardiac Surgery. N Engl J Med. 2017 Nov 30;377(22):2133-2144. doi: 10.1056/NEJMoa1711818. Epub 2017 Nov 12.

    PubMed 29130845
  • Fominskiy E, Putzu A, Monaco F, Scandroglio AM, Karaskov A, Galas FR, Hajjar LA, Zangrillo A, Landoni G. Liberal transfusion strategy improves survival in perioperative but not in critically ill patients. A meta-analysis of randomised trials. Br J Anaesth. 2015 Oct;115(4):511-9. doi: 10.1093/bja/aev317.

    PubMed 26385661
  • 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
  • Colson PH, Gaudard P, Fellahi JL, Bertet H, Faucanie M, Amour J, Blanloeil Y, Lanquetot H, Ouattara A, Picot MC; ARCOTHOVA group. Active Bleeding after Cardiac Surgery: A Prospective Observational Multicenter Study. PLoS One. 2016 Sep 2;11(9):e0162396. doi: 10.1371/journal.pone.0162396. eCollection 2016.

    PubMed 27588817

Questions about this trial

What is this clinical trial studying?

A study testing Adjusted Transfusion in people with Cardiac Surgery and Cardiopulmonary Bypass, 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 6 inclusion and 6 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 16 Jan 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?

RBC transfusion incidence (time frame: During cardiac surgery and postoperative ICU stay up to postoperative day 5). 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 NCT05740059, which also lists 14 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 16 Jan 2026.

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