Anemia Clinical Trial
— ICONEOfficial 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
Status | Recruiting |
Enrollment | 238 |
Est. completion date | December 18, 2025 |
Est. primary completion date | September 18, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age of 18 and older, - supported by peripheral VA-ECMO - for cardiogenic shock - Life expentency >90 days - Central venous line available ScVO2 measurement Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
France | Service d'Anesthésie-Réanimation CCV Hôpital Cardiologique Centre Hospitalier et Universitaire de Lille | Lille | Nord |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Lille | Amiens University Hospital, Centre hospitalier de Dunkerque, Centre Hospitalier de Lens, Centre Hospitalier Universitaire Dijon, University Hospital, Caen, University Hospital, Rouen |
France,
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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. — View Citation
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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 — View Citation
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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. — View Citation
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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 17 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of PRBCs transfused per VA-ECMO day of support | Total number of PRBCs transfused during support adjusted for VA- ECMO duration | From randomisation until VA-ECMO weanning assessed up to 28 days | |
Secondary | 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 | From randomisation until VA-ECMO weanning assessed up to 28 days | |
Secondary | Total number of PRBCs transfused during the 28-day following cannulation | Total number of PRBCs transfused during the 28-day following cannulation | From randomisation until 28 days | |
Secondary | Changes in hemoglobin levels during VA-ECMO support | daily hemoglobin levels | From randomisation until VA-ECMO weanning assessed up to 28 days | |
Secondary | Changes in ScVO2 levels during VA-ECMO support | daily ScVO2 levels | From randomisation until VA-ECMO weanning assessed up to 28 days | |
Secondary | Changes in vosoactive index score levels during VA-ECMO support | daily vasoactive index score levels | From randomisation until VA-ECMO weanning assessed up to 28 days | |
Secondary | Mortality under ECMO support | All cause mortality before ECMO weaning | From randomisation until VA-ECMO weanning assessed up to 28 days | |
Secondary | 90-day Mortality | All cause mortality from cannulation untill 90 days | 90 days from cannulation | |
Secondary | 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) | From randomisation until VA-ECMO weanning assessed up to 28 days | |
Secondary | Duration of mechanical ventilation | Duration of mechnanical ventilation from cannulation untill 28 days | 28 days from cannulation | |
Secondary | 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 | 28 days from cannulation | |
Secondary | Duration of vasoactive support | Duration of vasoactive drug support from cannulation untill 28 days | 28 days from cannulation | |
Secondary | Hospital lenght of stay | Length of stay from cannulation censored at 90 day | 28 days from cannulation | |
Secondary | HLA immuno-sensitisation | Proportion of HLA immunosensitisation occuring after cannulation | 28 and 90 days from cannulation | |
Secondary | Proportion of patient with Transfusion related immunologic ( non HLA-related) complications | Transfusion related acute lung injury, hemolytic anemia, irregular antibodies | From randomisation until 28 days | |
Secondary | Proportion of patients with nex onset of sepsis | Sepsis is defined according to Surviving Sepsis Campaign guideline | From randomisation until 28 days | |
Secondary | Proportion of patients with a new onset of acute kidney injury | Acute kidney injury is define according to KDIGO classification | From randomisation until 28 days | |
Secondary | Proportion of patients with liver failure | Liver failure is defined as Hepatic component of SOFA score, Transaminasis Levels | From randomisation until 28 days | |
Secondary | Ischemic stroke | Ischemic stroke is defined as clinical symptoms confirmed by aCT Scan of MRI imaging | From randomisation until 28 days | |
Secondary | Myocardial infarction | According to the Universal definition of myocardial infarction, ESC guidelines | From randomisation until 28 days | |
Secondary | Pulmonary oedema | Dignose by the attending physician based on (Dyspnae, Thoracic X-rays), bowel ischemia ( Abdominal CT or endoscopy proven) | From randomisation until 28 days | |
Secondary | Anaphylactic complications | Anaphylaxis defined according to Ring and Messer Classification | From randomisation until 28 days | |
Secondary | Bowel Ischemia | Proven by Abdominal CT or endoscopy | From randomisation until 28 days | |
Secondary | Cost effectiveness analysis | Actual costs at 28 and 90 days and modelisation for 5 years | 28 days, 90 days and 5 years from randomisation |
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