Cardiogenic ShockPhase 1ICONENCT05699005

Individualized or Conventional Transfusion Strategies During Peripheral VA-ECMO

A Phase 1 study testing Packed Red Blood Cells (PRBCs) in people with Cardiogenic Shock and Extracorporeal Membrane Oxygenation, run by University Hospital, Lille at 4 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

This multicenter randomized controlled trial compare two transfusion strategies of red blood cells transfusion in patients supported by veno-arterial extracorporeal membrane oxygenation for refractory cardiogenic shock. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Cardiogenic Shock, Extracorporeal Membrane Oxygenation, Transfusion Related Complication
What is being tested?: Packed Red Blood Cells (PRBCs)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 236 participants
Where: 4 sitesFrance
Study dates: 18 Sep 2023to 18 Dec 2028
Phase: Phase 1
Are there results?: Not yet: the study is under way

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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age of 18 and older,
supported by peripheral VA-ECMO
for cardiogenic shock
Life expentency >90 days
Central venous line available ScVO2 measurement

Who cannot join

Pregnancy,
Lack of health insurance,
Opposition to blood transfusion,
Known congenital hemoglobin disease or disorder,
Metabolic alcaloosis with pH>7.8,
eCPR,
Legally incapacitated adults

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Mouhamed MOUSSA, MD contact

0320445962

mouhamed.moussa@chru-lille.fr

France4 sites, 4 recruiting

CHU Amiens
Amiens
Yazine MAHJOUB, MD, 0033320444145, DRC@chu-lille.fr
Yazine MAHJOUB, MD
Recruiting
CHU Dijon
Dijon
Pierre-Grégoire GUINOT, MD, 0033320444145, DRC@chu-lille.fr
Pierre-Grégoire GUINOT, MD
Recruiting
Service d'Anesthésie-Réanimation CCV Hôpital Cardiologique Centre Hospitalier et Universitaire de Lille
Lille, NORD, 59000
Mouhamed D Moussa, MD, =33659248780, mouhamed.moussa@chru-lille.fr
julien.tabareau@chru-lille.fr
Recruiting
Centre de Réanimation, Hôpital Salengro, CHU Lille
Lille
Céline Boens, 0033320444145, DRC@chu-lille.fr
Thibault DUBURCQ, MD
Recruiting

Other trials in France

About this study

Official title: Comparison of an Individualized Transfusion Strategy to a Conventional Strategy in Patients Undergoing Peripheral Veno-arterial ECMO for Refractory Cardiogenic Shock: a Randomized Controlled Trial - ICONE

An individualized transfusion strategy based on ScVO2 level, is compared to a conventionnal strategy based on predefined hemoglobin threshold. The primary endpoint is the consumption of packed red blod cells, secondary endpoints are subgroup analysis, mortality, morbidity, and cost-effectiveness

Read the detailed description

Peripheral VA-ECMO is the mainstay of mechanical circulatory support in refractory cardiogenic shock. This treatment is associated with a high consumption of packed red blood cells (PRBCs), which can reach 1 to 3 units of PRBCs per day of support. The main reasons for such a high consumption of PRBCs are the very frequent hemorrhagic complications and the prevalence of anemias not directly related to the hemorrhagic episodes. These anemias are frequent during VA-ECMO support owing to hemolysis, hemodilution, previous bleeding episodes, thrombosis, etc.

In order to restore, maintain, or increase oxygen delivery (DO2) to peripheral organs, RGCs are often performed when anemia is observed. Several studies have reported an association between transfusion of these PRBCs with morbidity and mortality in this ECMO setting.

There is no appropriate strategy to reduce PRBC consumption, taking into account other determinants of DO2. In addition, there is currently no validated or consensus hemoglobin threshold to guide transfusion in this specific population. Furthermore, this predefined threshold-based approach may be inappropriate in the setting of VA-ECMO due to differences in DO2 requirements between patients based on their etiology, disease severity, and ECMO modality. In addition, large variations in DO2 can be observed in the same patient and between ECMO settings. Therefore, a more individualized strategy guided by a DO2 surrogate, ScVO2, may be more appropriate in this population. This ScVO2 approach has recently been shown to be associated with reduced PRBCs in two randomized controlled trials in cardiac surgery patients.

The objective of this multicenter randomized controlled trial is to compare two red cell transfusion strategies in patients receiving extracorporeal veno-arterial membrane oxygenation for refractory cardiogenic shock.

An individualized transfusion strategy based on ScVO2 level is compared with a conventional strategy based on a predefined hemoglobin threshold. The primary endpoint is red blood cell consumption, the secondary endpoints are subgroup analysis, mortality, morbidity, and cost-effectiveness.

Conditions: Cardiogenic Shock, Extracorporeal Membrane Oxygenation, Transfusion Related Complication, Anemia, Oxygen Delivery
Being tested: Packed Red Blood Cells (PRBCs)
Keywords: ECMO, ECLS, Refractory cardiogenic shock, Transfusion, ScVO2, Outcome
Medical subject headings: Shock, Cardiogenic, Anemia

What participants receive

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

Packed Red Blood Cells (PRBCs)Drug
Also called ScVO2 assesment to guide transfusion
Patient will recieve PRBCs transfusion only in case of ScVO2 level<65% after assessment of patient for optimisation of SaO2 targeting 100%, volume status, ECMO flow (increase to 20% in relevant), pain, anxiety and fever (body temperature >38°3).
In both groups transfusion may be performed in case massive bleeding according to local protocols, STEMI, Hyperlactatemia >4 that can be related to oxygen demand and supply DO2/VO2 ratio impairement, in all groups, transfusion should be performed in case of hemolobin level <7g/dL or worsening of neurological condition (Increase in Neurological SOFA component of 1 and more) related to DO2/VO2 impairement.

Study groups in NCT05699005
Study group	Role	What they receive
Individulised transfusion strategy group	Experimental	Patients will recieve red blood cells transfusion in case of a drop of ScVO2 <65% after an assessment for the optimisation of SaO2 normalisation (SaO2>94%), volume optimisation, ECMO output increase, Fever (body temperature 38°3 C°), Anxiety and Pain Receives: Drug: Packed Red Blood Cells (PRBCs)
Conventionnal transfusion strategy group	Active comparator	Transfusion will be performed in case of a hemoglobin drop <9 g/dL Receives: Drug: Packed Red Blood Cells (PRBCs)

What is being measured

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

Number of PRBCs transfused per VA-ECMO day of support
Total number of PRBCs transfused during support adjusted for VA- ECMO duration
Measured: From randomisation until VA-ECMO weanning assessed up to 28 days

Secondary outcomes (23)

Number of PRBCs transfused per VA-ECMO day of support in postcardiotomy patients
Total number of PRBCs transfused during support adjusted for VA- ECMO duration in patients that underwent cardiac surgery
Measured: From randomisation until VA-ECMO weanning assessed up to 28 days
Total number of PRBCs transfused during the 28-day following cannulation
Total number of PRBCs transfused during the 28-day following cannulation
Measured: From randomisation until 28 days
Changes in hemoglobin levels during VA-ECMO support
daily hemoglobin levels
Measured: From randomisation until VA-ECMO weanning assessed up to 28 days
Changes in ScVO2 levels during VA-ECMO support
daily ScVO2 levels
Measured: From randomisation until VA-ECMO weanning assessed up to 28 days
Changes in vosoactive index score levels during VA-ECMO support
daily vasoactive index score levels
Measured: From randomisation until VA-ECMO weanning assessed up to 28 days
Mortality under ECMO support
All cause mortality before ECMO weaning
Measured: From randomisation until VA-ECMO weanning assessed up to 28 days
90-day Mortality
All cause mortality from cannulation untill 90 days
Measured: 90 days from cannulation
ECMO removal modalities
Proportion of patients that according to each reason for removal ( Recovery, heart transplantation, Left ventricle or biventricle assist device or death under support)
Measured: From randomisation until VA-ECMO weanning assessed up to 28 days
Duration of mechanical ventilation
Duration of mechnanical ventilation from cannulation untill 28 days
Measured: 28 days from cannulation
Proportion of patient that received a renal replacement therapy and its duration
Number of patient that underwent a renal replacement therapy and duration of renal replacement therapy from cannulation untill 28 days
Measured: 28 days from cannulation
Duration of vasoactive support
Duration of vasoactive drug support from cannulation untill 28 days
Measured: 28 days from cannulation
Hospital lenght of stay
Length of stay from cannulation censored at 90 day
Measured: 28 days from cannulation
HLA immuno-sensitisation
Proportion of HLA immunosensitisation occuring after cannulation
Measured: 28 and 90 days from cannulation
Proportion of patient with Transfusion related immunologic ( non HLA-related) complications
Transfusion related acute lung injury, hemolytic anemia, irregular antibodies
Measured: From randomisation until 28 days
Proportion of patients with nex onset of sepsis
Sepsis is defined according to Surviving Sepsis Campaign guideline
Measured: From randomisation until 28 days
Proportion of patients with a new onset of acute kidney injury
Acute kidney injury is define according to KDIGO classification
Measured: From randomisation until 28 days
Proportion of patients with liver failure
Liver failure is defined as Hepatic component of SOFA score, Transaminasis Levels
Measured: From randomisation until 28 days
Ischemic stroke
Ischemic stroke is defined as clinical symptoms confirmed by aCT Scan of MRI imaging
Measured: From randomisation until 28 days
Myocardial infarction
According to the Universal definition of myocardial infarction, ESC guidelines
Measured: From randomisation until 28 days
Pulmonary oedema
Dignose by the attending physician based on (Dyspnae, Thoracic X-rays), bowel ischemia ( Abdominal CT or endoscopy proven)
Measured: From randomisation until 28 days
Anaphylactic complications
Anaphylaxis defined according to Ring and Messer Classification
Measured: From randomisation until 28 days
Bowel Ischemia
Proven by Abdominal CT or endoscopy
Measured: From randomisation until 28 days
Cost effectiveness analysis
Actual costs at 28 and 90 days and modelisation for 5 years
Measured: 28 days, 90 days and 5 years from randomisation

Timeline

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

18 Sep 202318 Dec 2028

First posted26 Jan 2023
Study start18 Sep 2023
Primary completion18 Mar 2028 (estimated)
Study completion18 Dec 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (17)Papers the sponsor has linked to this study.
Other trials for Cardiogenic ShockStudies of the same condition, open and under way.
More trials run by University Hospital, LilleThe 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 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 236 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05699005
Sponsor's protocol ID: 2020_04
Other IDs: 2021-A01925-36, PHRCI-19-032
Acronym: ICONE
Status last verified: Jun 2026
First submitted: 21 Dec 2022
Last updated: 17 Sep 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

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
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
Vallet B, Robin E, Lebuffe G. Venous oxygen saturation as a physiologic transfusion trigger. Crit Care. 2010;14(2):213. doi: 10.1186/cc8854. Epub 2010 Mar 9.
PubMed 20236457
Aubron C, Cheng AC, Pilcher D, Leong T, Magrin G, Cooper DJ, Scheinkestel C, Pellegrino V. Factors associated with outcomes of patients on extracorporeal membrane oxygenation support: a 5-year cohort study. Crit Care. 2013 Apr 18;17(2):R73. doi: 10.1186/cc12681.
PubMed 23594433
Mazzeffi M, Greenwood J, Tanaka K, Menaker J, Rector R, Herr D, Kon Z, Lee J, Griffith B, Rajagopal K, Pham S. Bleeding, Transfusion, and Mortality on Extracorporeal Life Support: ECLS Working Group on Thrombosis and Hemostasis. Ann Thorac Surg. 2016 Feb;101(2):682-9. doi: 10.1016/j.athoracsur.2015.07.046. Epub 2015 Oct 9.
PubMed 26443879
Holst LB. Benefits and harms of red blood cell transfusions in patients with septic shock in the intensive care unit. Dan Med J. 2016 Feb;63(2):B5209.
PubMed 26836806
Rohde JM, Dimcheff DE, Blumberg N, Saint S, Langa KM, Kuhn L, Hickner A, Rogers MA. Health care-associated infection after red blood cell transfusion: a systematic review and meta-analysis. JAMA. 2014 Apr 2;311(13):1317-26. doi: 10.1001/jama.2014.2726.
PubMed 24691607
Leffell MS, Kim D, Vega RM, Zachary AA, Petersen J, Hart JM, Rossert J, Bradbury BD. Red blood cell transfusions and the risk of allosensitization in patients awaiting primary kidney transplantation. Transplantation. 2014 Mar 15;97(5):525-33. doi: 10.1097/01.tp.0000437435.19980.8f.
PubMed 24300013
Vlaar AP, Hofstra JJ, Determann RM, Veelo DP, Paulus F, Kulik W, Korevaar J, de Mol BA, Koopman MM, Porcelijn L, Binnekade JM, Vroom MB, Schultz MJ, Juffermans NP. The incidence, risk factors, and outcome of transfusion-related acute lung injury in a cohort of cardiac surgery patients: a prospective nested case-control study. Blood. 2011 Apr 21;117(16):4218-25. doi: 10.1182/blood-2010-10-313973. Epub 2011 Feb 16.
PubMed 21325598
Lorusso R, Gelsomino S, Parise O, Mendiratta P, Prodhan P, Rycus P, MacLaren G, Brogan TV, Chen YS, Maessen J, Hou X, Thiagarajan RR. Venoarterial Extracorporeal Membrane Oxygenation for Refractory Cardiogenic Shock in Elderly Patients: Trends in Application and Outcome From the Extracorporeal Life Support Organization (ELSO) Registry. Ann Thorac Surg. 2017 Jul;104(1):62-69. doi: 10.1016/j.athoracsur.2016.10.023. Epub 2017 Jan 26.
PubMed 28131429
Kim HS, Park S. Blood Transfusion Strategies in Patients Undergoing Extracorporeal Membrane Oxygenation. Korean J Crit Care Med. 2017 Feb;32(1):22-28. doi: 10.4266/kjccm.2016.00983. Epub 2017 Feb 28.
PubMed 31723612
Hebert PC, Wells G, Blajchman MA, Marshall J, Martin C, Pagliarello G, Tweeddale M, Schweitzer I, Yetisir E. A multicenter, randomized, controlled clinical trial of transfusion requirements in critical care. Transfusion Requirements in Critical Care Investigators, Canadian Critical Care Trials Group. N Engl J Med. 1999 Feb 11;340(6):409-17. doi: 10.1056/NEJM199902113400601.
PubMed 9971864
Holst LB, Petersen MW, Haase N, Perner A, Wetterslev J. Restrictive versus liberal transfusion strategy for red blood cell transfusion: systematic review of randomised trials with meta-analysis and trial sequential analysis. BMJ. 2015 Mar 24;350:h1354. doi: 10.1136/bmj.h1354.
PubMed 25805204
Mueller MM, Van Remoortel H, Meybohm P, Aranko K, Aubron C, Burger R, Carson JL, Cichutek K, De Buck E, Devine D, Fergusson D, Follea G, French C, Frey KP, Gammon R, Levy JH, Murphy MF, Ozier Y, Pavenski K, So-Osman C, Tiberghien P, Volmink J, Waters JH, Wood EM, Seifried E; ICC PBM Frankfurt 2018 Group. Patient Blood Management: Recommendations From the 2018 Frankfurt Consensus Conference. JAMA. 2019 Mar 12;321(10):983-997. doi: 10.1001/jama.2019.0554.
PubMed 30860564
Guimbretiere G, Anselmi A, Roisne A, Lelong B, Corbineau H, Langanay T, Flecher E, Verhoye JP. Prognostic impact of blood product transfusion in VA and VV ECMO. Perfusion. 2019 Apr;34(3):246-253. doi: 10.1177/0267659118814690. Epub 2018 Nov 16.
PubMed 30444173

Interested in taking part?

Mouhamed MOUSSA, MD

0320445962

mouhamed.moussa@chru-lille.fr

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of an Individualized Transfusion Strategy to a Conventional Strategy in Patients Undergoing Peripheral Veno-arterial ECMO for Refractory Cardiogenic Shock: a Randomized Controlled Trial - ICONE
ClinicalTrials.gov ID: NCT05699005
Acronym / sponsor ID: ICONE / 2020_04
Conditions: Cardiogenic Shock, Extracorporeal Membrane Oxygenation, Transfusion Related Complication, Anemia, Oxygen Delivery
Keywords: ECMO, ECLS, Refractory cardiogenic shock, Transfusion, ScVO2, Outcome
Phase: Phase 1
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 236 participants (estimated)
Lead sponsor: University Hospital, LilleUniversity, hospital or other
Collaborators: Amiens University Hospital, University Hospital, Caen, University Hospital, Rouen, Centre Hospitalier Universitaire Dijon, Centre Hospitalier de Lens
Study start: 18 Sep 2023 (actual)
Primary completion: 18 Mar 2028 (estimated)
Study completion: 18 Dec 2028 (estimated)
First posted: 26 Jan 2023 (actual)
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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Individulised transfusion strategy group	Experimental	Drug: Packed Red Blood Cells (PRBCs)Patients will recieve red blood cells transfusion in case of a drop of ScVO2 <65% after an assessment for the optimisation of SaO2 normalisation (SaO2>94%), volume optimisation, ECMO output increase, Fever (body temperature 38°3 C°), Anxiety and Pain
Conventionnal transfusion strategy group	Active comparator	Drug: Packed Red Blood Cells (PRBCs)Transfusion will be performed in case of a hemoglobin drop <9 g/dL

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Age of 18 and older,
supported by peripheral VA-ECMO
for cardiogenic shock
Life expentency >90 days
Central venous line available ScVO2 measurement

Key exclusion criteria (7 listed)

Pregnancy,
Lack of health insurance,
Opposition to blood transfusion,
Known congenital hemoglobin disease or disorder,
Metabolic alcaloosis with pH>7.8,

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
Packed Red Blood Cells (PRBCs)Also: ScVO2 assesment to guide transfusionPatient will recieve PRBCs transfusion only in case of ScVO2 level<65% after assessment of patient for optimisation of SaO2 targeting 100%, volume status, ECMO flow (increase to 20% in relevant), pain, anxiety and fever (body temperature >38°3). In both groups transfusion may be performed in case massive bleeding according to local protocols, STEMI, Hyperlactatemia >4 that can be related to oxygen demand and supply DO2/VO2 ratio impairement, in all groups, transfusion should be performed in case of hemolobin level <7g/dL or worsening of neurological condition (Increase in Neurological SOFA component of 1 and more) related to DO2/VO2 impairement.	Drug	Conventionnal transfusion strategy group, Individulised transfusion strategy group

Primary outcome

Number of PRBCs transfused per VA-ECMO day of support
Time frame: From randomisation until VA-ECMO weanning assessed up to 28 days
Total number of PRBCs transfused during support adjusted for VA- ECMO duration

23 secondary outcomes

Number of PRBCs transfused per VA-ECMO day of support in postcardiotomy patients
Time frame: From randomisation until VA-ECMO weanning assessed up to 28 days
Total number of PRBCs transfused during the 28-day following cannulation
Time frame: From randomisation until 28 days
Changes in hemoglobin levels during VA-ECMO support
Time frame: From randomisation until VA-ECMO weanning assessed up to 28 days
Changes in ScVO2 levels during VA-ECMO support
Time frame: From randomisation until VA-ECMO weanning assessed up to 28 days
Changes in vosoactive index score levels during VA-ECMO support
Time frame: From randomisation until VA-ECMO weanning assessed up to 28 days
Mortality under ECMO support
Time frame: From randomisation until VA-ECMO weanning assessed up to 28 days
90-day Mortality
Time frame: 90 days from cannulation
ECMO removal modalities
Time frame: From randomisation until VA-ECMO weanning assessed up to 28 days
Duration of mechanical ventilation
Time frame: 28 days from cannulation
Proportion of patient that received a renal replacement therapy and its duration
Time frame: 28 days from cannulation
Duration of vasoactive support
Time frame: 28 days from cannulation
Hospital lenght of stay
Time frame: 28 days from cannulation
HLA immuno-sensitisation
Time frame: 28 and 90 days from cannulation
Proportion of patient with Transfusion related immunologic ( non HLA-related) complications
Time frame: From randomisation until 28 days
Proportion of patients with nex onset of sepsis
Time frame: From randomisation until 28 days
Proportion of patients with a new onset of acute kidney injury
Time frame: From randomisation until 28 days
Proportion of patients with liver failure
Time frame: From randomisation until 28 days
Ischemic stroke
Time frame: From randomisation until 28 days
Myocardial infarction
Time frame: From randomisation until 28 days
Pulmonary oedema
Time frame: From randomisation until 28 days
Anaphylactic complications
Time frame: From randomisation until 28 days
Bowel Ischemia
Time frame: From randomisation until 28 days
Cost effectiveness analysis
Time frame: 28 days, 90 days and 5 years from randomisation

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
Background: PubMed 29130845Mazer 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.
Background: 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.
Results publication: PubMed 20236457Vallet B, Robin E, Lebuffe G. Venous oxygen saturation as a physiologic transfusion trigger. Crit Care. 2010;14(2):213. doi: 10.1186/cc8854. Epub 2010 Mar 9.
Results publication: PubMed 23594433Aubron C, Cheng AC, Pilcher D, Leong T, Magrin G, Cooper DJ, Scheinkestel C, Pellegrino V. Factors associated with outcomes of patients on extracorporeal membrane oxygenation support: a 5-year cohort study. Crit Care. 2013 Apr 18;17(2):R73. doi: 10.1186/cc12681.
Results publication: PubMed 26443879Mazzeffi M, Greenwood J, Tanaka K, Menaker J, Rector R, Herr D, Kon Z, Lee J, Griffith B, Rajagopal K, Pham S. Bleeding, Transfusion, and Mortality on Extracorporeal Life Support: ECLS Working Group on Thrombosis and Hemostasis. Ann Thorac Surg. 2016 Feb;101(2):682-9. doi: 10.1016/j.athoracsur.2015.07.046. Epub 2015 Oct 9.
Results publication: PubMed 26836806Holst LB. Benefits and harms of red blood cell transfusions in patients with septic shock in the intensive care unit. Dan Med J. 2016 Feb;63(2):B5209.
Results publication: PubMed 24691607Rohde JM, Dimcheff DE, Blumberg N, Saint S, Langa KM, Kuhn L, Hickner A, Rogers MA. Health care-associated infection after red blood cell transfusion: a systematic review and meta-analysis. JAMA. 2014 Apr 2;311(13):1317-26. doi: 10.1001/jama.2014.2726.
Results publication: PubMed 24300013Leffell MS, Kim D, Vega RM, Zachary AA, Petersen J, Hart JM, Rossert J, Bradbury BD. Red blood cell transfusions and the risk of allosensitization in patients awaiting primary kidney transplantation. Transplantation. 2014 Mar 15;97(5):525-33. doi: 10.1097/01.tp.0000437435.19980.8f.
Results publication: PubMed 21325598Vlaar AP, Hofstra JJ, Determann RM, Veelo DP, Paulus F, Kulik W, Korevaar J, de Mol BA, Koopman MM, Porcelijn L, Binnekade JM, Vroom MB, Schultz MJ, Juffermans NP. The incidence, risk factors, and outcome of transfusion-related acute lung injury in a cohort of cardiac surgery patients: a prospective nested case-control study. Blood. 2011 Apr 21;117(16):4218-25. doi: 10.1182/blood-2010-10-313973. Epub 2011 Feb 16.
Results publication: PubMed 28131429Lorusso R, Gelsomino S, Parise O, Mendiratta P, Prodhan P, Rycus P, MacLaren G, Brogan TV, Chen YS, Maessen J, Hou X, Thiagarajan RR. Venoarterial Extracorporeal Membrane Oxygenation for Refractory Cardiogenic Shock in Elderly Patients: Trends in Application and Outcome From the Extracorporeal Life Support Organization (ELSO) Registry. Ann Thorac Surg. 2017 Jul;104(1):62-69. doi: 10.1016/j.athoracsur.2016.10.023. Epub 2017 Jan 26.
Results publication: PubMed 31723612Kim HS, Park S. Blood Transfusion Strategies in Patients Undergoing Extracorporeal Membrane Oxygenation. Korean J Crit Care Med. 2017 Feb;32(1):22-28. doi: 10.4266/kjccm.2016.00983. Epub 2017 Feb 28.
Results publication: PubMed 9971864Hebert PC, Wells G, Blajchman MA, Marshall J, Martin C, Pagliarello G, Tweeddale M, Schweitzer I, Yetisir E. A multicenter, randomized, controlled clinical trial of transfusion requirements in critical care. Transfusion Requirements in Critical Care Investigators, Canadian Critical Care Trials Group. N Engl J Med. 1999 Feb 11;340(6):409-17. doi: 10.1056/NEJM199902113400601.
Individual participant dataSharing planned: Undecided

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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.

Mouhamed MOUSSA, MD contact

0320445962

mouhamed.moussa@chru-lille.fr

Mouhamed MOUSSA, MD principal investigator

University Hospital, Lille

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Packed Red Blood Cells (PRBCs) in people with Cardiogenic Shock and Extracorporeal Membrane Oxygenation, run by University Hospital, Lille at 4 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 7 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: looking for participants now, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Mouhamed MOUSSA, MD (0320445962, mouhamed.moussa@chru-lille.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of PRBCs transfused per VA-ECMO day of support (time frame: From randomisation until VA-ECMO weanning assessed up to 28 days). 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 NCT05699005, which also lists 17 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 17 Sep 2026.