- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03261583
Impact of Preoperative Martial Deficiency on the Level of Blood Transfusion in Programmed Cardiac Surgery (CARMATS)
Impact of Preoperative Martial Deficiency on the Level of Blood Transfusion in Programmed Cardiac Surgery (CARMATS)
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Blood transfusion is expensive, and has medical and safety consequences for patients who benefit from it. In cardiac surgery, the data concerning the level of perioperative transfusion are very heterogeneous from one center to another. In a large US cohort study of 798 cardiac surgery centers and 102,470 patients undergoing coronary artery bypass surgery, the rate of blood transfusion varies from 8 to 93% depending on the center. It would appear that the largest and most experienced centers have a blood transfusion rate of around 60%.
In addition to its beneficial role in reducing mortality induced by deep or poorly tolerated anemia, current data from the literature also raise morbidity and mortality related to blood transfusion. Murphy et al. Have shown, in an English cohort of cardiac surgery, that transfusion of CGR was correlated with the occurrence of postoperative infections and ischemic events, as well as early and late excess mortality. These effects appear as early as the first transfused red blood cell, which is confirmed by a prospective Brazilian study with a hazard ratio of death occurrence of 1.2 for each RBC transfused after cardiac surgery.
Preoperative anemia is found in 25% of patients in programmed cardiac surgery and its etiologies are varied. Iron deficiency appears to be at the forefront, especially in coronary patients for whom studies report up to 48% iron deficiency anemia. It may also be vitamin B12 deficiency or folate, chronic pathologies such as renal insufficiency, or any other common cause of anemia.
According to the latest European recommendations, iron deficiency should be defined as <100 ng / mL ferritin or <300 ng / mL ferritin combined with a transferrin saturation <20%.
In cardiac surgery, iron deficiency affects 37% of preoperative patients and is associated with more frequent preoperative and postoperative anemia. It is an independent risk factor for postoperative blood transfusion, even in the absence of preoperatively associated anemia It is currently recommended to seek iron deficiency preoperatively during the discovery of any microcytic anemia and to achieve iron substitution if found. And also to seek supplemental iron deficiency in all patients with cardiac insufficiency.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Brest, Francia, 29609
- Brest University Hospital
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Rennes, Francia, 35033
- Rennes University Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
All adult patients programmed for cardiac surgery in the cardiothoracic surgery departments of Rennes, Poitiers, and Brest.
Exclusion Criteria:
- Children <18 years;
- Procedures for endovascular surgery;
- Vascular surgery other than ascending aorta and lacrosse;
- Non-cardiac thoracic surgery;
- Persons of full age who are subject to legal protection (safeguard of justice, curatorship, guardianship), persons deprived of their liberty.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
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Thoracic Surgery
Observational study.
It is only a matter of collecting clinical data.
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Observational study.
It is only a matter of collecting clinical data.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Incidence of patients with iron deficiency
Periodo de tiempo: Baseline
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Baseline
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Baptiste Gaudriot, Chu Rennes
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- 35RC16_3051_CARMATS
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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