Individualized or Conventional Transfusion Strategies During Peripheral VA-ECMO

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

• Препарат Packed Red Blood Cells (PRBCs)
  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

Первичные конечные точки

• Number of PRBCs transfused per VA-ECMO day of support [Срок оценки: From randomisation until VA-ECMO weanning assessed up to 28 days]

Вторичные конечные точки (12)

• Number of PRBCs transfused per VA-ECMO day of support in postcardiotomy patients [Срок оценки: From randomisation until VA-ECMO weanning assessed up to 28 days]
• Total number of PRBCs transfused during the 28-day following cannulation [Срок оценки: From randomisation until 28 days]
• Changes in hemoglobin levels during VA-ECMO support [Срок оценки: From randomisation until VA-ECMO weanning assessed up to 28 days]
• Changes in ScVO2 levels during VA-ECMO support [Срок оценки: From randomisation until VA-ECMO weanning assessed up to 28 days]
• Changes in vosoactive index score levels during VA-ECMO support [Срок оценки: From randomisation until VA-ECMO weanning assessed up to 28 days]
• Mortality under ECMO support [Срок оценки: From randomisation until VA-ECMO weanning assessed up to 28 days]
• 90-day Mortality [Срок оценки: 90 days from cannulation]
• ECMO removal modalities [Срок оценки: From randomisation until VA-ECMO weanning assessed up to 28 days]
• Duration of mechanical ventilation [Срок оценки: 28 days from cannulation]
• Proportion of patient that received a renal replacement therapy and its duration [Срок оценки: 28 days from cannulation]
• Duration of vasoactive support [Срок оценки: 28 days from cannulation]
• Hospital lenght of stay [Срок оценки: 28 days from cannulation]

Критерии участия

Критерии включения

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Франция · 1 центр

• Service d'Anesthésie-Réanimation CCV Hôpital Cardiologique Centre Hospitalier et Universit — Lille

Публикации

• 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 PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 24300013

Идентификаторы

NCT: NCT05699005 · 2020_04 · 2021-A01925-36 · PHRCI-19-032

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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