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.
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
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.
France4 sites, 4 recruiting
- 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
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
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.
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 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.
- 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.
- 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)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Amiens University Hospital, University Hospital, Caen, University Hospital, Rouen, Centre Hospitalier Universitaire Dijon, Centre Hospitalier de Lens
- Responsible party
- Sponsor
- Investigators
- Mouhamed MOUSSA, MD, Principal investigator, University Hospital, Lille
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 29130845Fischer 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 34862002Vallet 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 20236457Aubron 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 23594433Mazzeffi 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 26443879Holst 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 26836806Rohde 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 24691607Leffell 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 24300013Vlaar 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 21325598Lorusso 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 28131429Kim 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 31723612Hebert 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 9971864Holst 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 25805204Mueller 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 30860564Guimbretiere 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