Cost-effectiveness and cost usefulness of a liberal versus other restrictive blood cell transfusion strategy in patients with acute myocardial infarction and anemia. Studio REALITY. (Q3142985)
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Project Q3142985 in Spain
| Language | Label | Description | Also known as |
|---|---|---|---|
| English | Cost-effectiveness and cost usefulness of a liberal versus other restrictive blood cell transfusion strategy in patients with acute myocardial infarction and anemia. Studio REALITY. |
Project Q3142985 in Spain |
Statements
25,200.0 Euro
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31,500.0 Euro
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80.0 percent
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1 January 2016
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31 October 2019
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FUNDACION INSTITUTO DE INVESTIGACION SANITARIA DE SANTIAGO DE COMPOSTELA
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42°52'49.51"N, 8°32'45.10"W
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15078
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La anemia es frecuente en pacientes con infarto de miocardio (IM) y es un predictor independiente de morbimortalidad. Sin embargo, se desconoce si transfundir hematíes incrementa efectivamente la entrega de oxígeno a los tejidos o si incluso podría ser perjudicial en pacientes con enfermedad cardiovascular (CV). En pacientes con IM, tanto los efectos de la anemia como los riesgos de la transfusión podrían estar amplificados, lo que incrementa la incertidumbre sobre qué estrategia de transfusión se debería seguir (liberal vs restrictiva). Las únicas recomendaciones al respecto son las de la ESC en SCASEST, que sugieren transfundir sólo si el estado hemodinámico se ve comprometida o la hemoglobina es menor que 7 g/dl. En pacientes con IM con elevación del ST no hay recomendaciones al respecto. En la práctica clínica la variabilidad es enorme entre países y entre centros. Hipótesis: una estrategia restrictiva de transfusión Hb menor de 7 g/dl será clínicamente no inferior a una estrategia liberal provocada por Hb menor de 10g/dl, y será menos costosa. Objetivo principal: comparar el coste-efectividad de la estrategia restrictiva vs la estrategia liberal en pacientes con infarto agudo de miocardio y anemia. Objetivos secundarios clave: a.) análisis de coste-utilidad a los 30 días y 1 año; b.) determinar si una estrategia de transfusión restrictiva es clínicamente no inferior a una estrategia liberal transfusión en términos de MACE a los 30 días. Diseño: Se trata de un ensayo clínico multicéntrico internacional sin medicamentos (España, Francia, Reino Unido y Noruega). (Spanish)
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Anaemia is common in patients with myocardial infarction (MI) and is an independent predictor of morbidity and mortality. However, it is not known whether transfused blood cells effectively increases oxygen delivery to tissues or could even be harmful in patients with cardiovascular disease (CV). In patients with IM, both the effects of anaemia and the risks of transfusion may be amplified, increasing uncertainty about which transfusion strategy should be followed (liberal vs restrictive). The only recommendations in this regard are those of STECS, which suggest transfused only if the hemodynamic state is compromised or the hemoglobin is less than 7 g/dl. There are no recommendations in patients with ST elevation. In clinical practice, the variability is enormous between countries and between centers. Scenario: a restrictive Hb transfusion strategy of less than 7 g/dl shall be clinically no less than a liberal strategy caused by Hb less than 10 g/dl, and will be less costly. Main objective: compare the cost-effectiveness of restrictive strategy vs liberal strategy in patients with acute myocardial infarction and anemia. Key secondary objectives: a.) cost-utility analysis at 30 days and 1 year; b.) determine whether a restrictive transfusion strategy is clinically not inferior to a liberal transfusion strategy in terms of MACE at 30 days. Design: This is an international multicenter clinical trial without medicines (Spain, France, United Kingdom and Norway). (English)
12 October 2021
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Santiago de Compostela
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Identifiers
PI15_01498
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