Restrictive Transfusion StratEgy Adjusted by SvO2 During Cardiac Surgery

NCT05740059 | Completed DMC

• 1 other identifier: RECHMPL21_0529
• Study Type: interventional
• Target: 676
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Cardiac Surgery; Cardiopulmonary Bypass

Keywords

Blood transfusion; Cardiac surgery

Outcome Measures

Primary Outcomes (1)

• RBC transfusion incidence

  Proportion of RBC transfused patients

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

Secondary Outcomes (19)

• RBC transfusion incidence during surgery

  During cardiac surgery

• RBC units transfused during surgery

  During cardiac surgery

• RBC transfusion incidence during postoperative ICU stay

  During postoperative ICU stay

• RBC units transfused during postoperative ICU stay

  During postoperative ICU stay

• RBC transfusion incidence at hospital discharge or day 28

  From cadiac surgery to hospital discharge or day 28

Study Arms (2)

Control

NO INTERVENTION

Patients assigned to the Control group will be transfused if hemoglobin (Hb) concentration is lower than 9 g/d.

Adjusted transfusion

ACTIVE COMPARATOR

Patients assigned to the SvO2 group will be transfused if Hb concentration is lower than 9 g/dL and central SvO2 ≤ 65%.

Other: Adjusted Transfusion

Interventions

Adjusted Transfusion OTHER

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.

Adjusted transfusion

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged above 18 years and under 85 years
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Departement d'anesthésie et réanimation D - Arnaud de Villeneuve

Montpellier, 34295, France

Location

Related Publications (14)

• 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.

  PMID: 20940382 RESULT

• 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.

  PMID: 17462454 RESULT

• 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.

  PMID: 20940381 RESULT

• 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.

  PMID: 9477051 RESULT

• 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.

  PMID: 17998460 RESULT

• 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.

  PMID: 16631651 RESULT

• 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.

  PMID: 24094521 RESULT

• 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.

  PMID: 25545654 RESULT

• 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.

  PMID: 21353044 RESULT

• 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.

  PMID: 29029100 RESULT

• 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.

  PMID: 29130845 RESULT

• 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.

  PMID: 26385661 RESULT

• 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.

  PMID: 33475735 RESULT

• 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.

  PMID: 27588817 RESULT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients won't be aware of the assignment group
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multi-center, single-blinded, and randomized controlled trial.

Study Record Dates

• First Submitted: February 6, 2023
• First Posted: February 22, 2023
• Study Start: March 14, 2023
• Primary Completion: October 15, 2025
• Study Completion: October 21, 2025
• Last Updated: January 16, 2026

Record last verified: 2025-12

Locations

FR (1)