Restrictive Transfusion StratEgy Adjusted by SvO2 During Cardiac Surgery

Cardiac Surgery Clinical Trial

— RETSEACSII  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05740059
• Other study ID #: 21_0529
• Status: Recruiting
• Phase: N/A
• Start date: March 14, 2023
• Est. completion date: December 12, 2025

Study information

• Verified date: January 2024
• Source: University Hospital, Montpellier
• Contact: Pascal COLSON, MD
• Phone: +33467335957
• Email: p-colson[@]chu-montpellier.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 676
• Est. completion date: December 12, 2025
• Est. primary completion date: November 19, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Cardiac Surgery
• Cardiopulmonary Bypass

Intervention

Other:
• Adjusted Transfusion
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.

Locations

Country	Name	City	State
France	Departement d'anesthésie et réanimation D - Arnaud de Villeneuve	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

References & Publications (14)

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*. Anest — View Citation

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. — View Citation

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. do — View Citation

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 — View Citation

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 — View Citation

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. — View Citation

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, M — View Citation

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/CIRCULA — View Citation

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 Cardio — View Citation

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 — View Citation

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-Lesserso — View Citation

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 Bl — View Citation

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 — View Citation

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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	RBC transfusion incidence	Proportion of RBC transfused patients	During cardiac surgery and postoperative ICU stay up to postoperative day 5
Secondary	RBC transfusion incidence during surgery	Proportion of patients transfused with RBC during surgery	During cardiac surgery
Secondary	RBC units transfused during surgery	Number of RBC units transfused during surgery	During cardiac surgery
Secondary	RBC transfusion incidence during postoperative ICU stay	Proportions of patients transfused with RBC during postoperative ICU stay	During postoperative ICU stay
Secondary	RBC units transfused during postoperative ICU stay	Number of RBC units transfused during postoperative stay in ICU	During postoperative ICU stay
Secondary	RBC transfusion incidence at hospital discharge or day 28	Proportions of patients transfused with RBC at hospital discharge or day 28	From cadiac surgery to hospital discharge or day 28
Secondary	RBC units transfused at hospital discharge or day 28	Number of RBC units transfused at hospital discharge or day 28	From cardiac surgery to hospital discharge or day 28
Secondary	Postoperative septic complications	Proportion of postoperative septic complications	From cardiac surgery to hospital discharge or day 28
Secondary	Postoperative ischemic complications	Proportion of postoperative ischemic complications (myocardial infarction, stroke, mesenteric)	From cardiac surgery to hospital discharge or day 28
Secondary	Postoperative acute kidney injury	Proportion postoperative AKI according to Kdigo stages	From cardiac surgery to hospital discharge or day 28
Secondary	Postoperative liver dysfuncion	Proportion of postoperative increase in binirubin or plasma hepatic enzymes	From cardiac surgery to hospital discharge or day 28
Secondary	Postoperative respiratory failure	Proportion of postoperative of Pa/Fi<200	From cardiac surgery to hospital discharge or day 28
Secondary	Postoperative low cardiac output syndrome	Proportion of low cardiac output	From cardiac surgery to hospital discharge or day 28
Secondary	Postoperative arythmias	Proportion of atrial fibrillation	From cardiac surgery to hospital discharge or day 28
Secondary	Length of ICU stay	ICU length of stay (number of days)	From ICU admission to ICU discharge ofr day 28
Secondary	Length of hospital stay	Hospital length of stay (number of days)	From ICU admission to hospital discharge or day 28
Secondary	Postoperative anemia	Hemoglobin concentration	From ICU admission to hospital discharge or day 28
Secondary	Death	Proportion of deaths	From cardiac surgery to hospital discharge or day 28
Secondary	Effect of RBC transfusion on Hb	Hb changes after RBC transfusion	During cardiac surgery and postoperative ICU stay up to postoperative day 5
Secondary	Effect of RBC transfusion on central SvO2	Central SvO2 changes after RBC transfusion	During cardiac surgery and postoperative ICU stay up to postoperative day 5