Development of a Predictive Score for the Risk of Infection in the Immediate Post-liver-transplant Period (PREDITH)
Liver transplantation (LT) is the only curative treatment option for patients with severe liver disease. Since 2007, the implementation of the MELD score in liver transplant allocation guidelines has led to a change in the profile of transplant recipients, notably with an increase in the proportion of patients receiving transplants for severe liver failure. Thus, in 2023, nearly 40% of liver transplant recipients whose primary indication for LT was cirrhosis had a MELD score greater than 35 (ABM Scientific Report 2023). These patients with severe pre-transplant liver failure often present with associated organ failure (Acute-on-Chronic Liver Failure, ACLF). Infections are the leading cause of death at 1 year post-transplant for patients transplanted with ACLF and are a major concern for all patients, representing one of the leading causes of death at 3 months post-transplant. Another common complication following LT is acute cellular rejection. Although frequent, this complication is reversible with treatment and results in graft loss in fewer than 5% of cases.
The expression of the HLA-DR marker by monocytes (mHLA-DR) is correlated with immunoparesis and the risk of secondary infection and mortality in patients admitted to critical care. In a prospective, single-center pilot study of 99 liver transplant recipients, the Hepatology and Gastroenterology service at the Croix Rousse Hospital, Hospices Civils de Lyon, demonstrated that the kinetics of mHLA-DR levels measured immediately after transplantation could predict the risk of early significant infection (< 1 month) after transplantation and 1-year post-transplant mortality. The early post-transplant kinetics of mHLA-DR expression recovery appeared to be a more relevant predictor of the risk of early post-transplant infection than a single-point-in-time value. The profile of immune recovery kinetics, as well as a pre-LT MELD score > 30, were associated in multivariate analysis with the risk of developing an infection at 1 month post-LT and with 1-year post-LT survival.
PREDITH study team hypothesize that the implementation of mHLA-DR testing immediately post-LT would enable the development of a predictive score for early post-LT infection combining clinical and biological risk factors for post-LT infection and immune monitoring.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: LEBOSSE Fanny, Dr
- Número de teléfono: +33 4 26 10 93 39
- Correo electrónico: fanny.lebosse@chu-lyon.fr
Copia de seguridad de contactos de estudio
- Nombre: DELIGNETTE Marie Charlotte, Dr
- Número de teléfono: +33 4 26 10 90 70
- Correo electrónico: marie-charlotte.delignette@chu-lyon.fr
Ubicaciones de estudio
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Clermont-Ferrand, Francia, 63100
- Department of Hepatology and Gastroenterology - CHU de Clermont Ferrand
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Contacto:
- Abergel Armand, Pr
- Número de teléfono: +33 4 73.75.05.04
- Correo electrónico: aabergel@chu-clermontferrand.fr
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Lyon, Francia, 69004
- Department of Hepatology and Gastroenterology - Hôpital de la Croix-Rousse
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Contacto:
- LEBOSSE Fanny, Dr
- Número de teléfono: +33 4 26 10 93 39
- Correo electrónico: fanny.lebosse@chu-lyon.fr
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Contacto:
- DELIGNETTE Marie-Charlotte, Dr
- Número de teléfono: +33 4 26 10 90 70
- Correo electrónico: marie-charlotte.delignette@chu-lyon.fr
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Montpellier, Francia, 34090
- Department of Hepatology and Gastroenterology - Hôpital Saint Eloi
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Contacto:
- Bedoya Jose Ursic, Dr
- Número de teléfono: 33 4 67.33.70.62
- Correo electrónico: jose.ursicbedoya@chu-montpellier.fr
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Contacto:
- Monet Clément, Dr
- Número de teléfono: +33 4 67.33.02.62
- Correo electrónico: c-monet@chu-montpellier.fr
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
Patients awaiting liver transplantation for one of the following indications:
- Compensated cirrhosis complicated by hepatocellular carcinoma
- Chronically decompensated cirrhosis (recurrent gastrointestinal bleeding, refractory ascites, portopulmonary or hepatopulmonary syndrome, hepatic encephalopathy, chronic liver failure)
- Acute decompensated cirrhosis, with or without associated multiple organ failure (ACLF)
- Acute fulminant hepatitis
Final inclusion will be :
- Patients receiving LT AND
- Who provided their consent to participate during the initial enrollment visit AND
- For whom the baseline sample (during the day of the LT) was collected
Exclusion Criteria:
- Minors
- Patients under legal guardianship or conservatorship
- Pregnant or breastfeeding women
- Patients deprived of their liberty
- Patients not enrolled in the social security system
- Refusal to participate in the study
- Patients receiving immunosuppressive therapy prior to LT (with the exception of corticosteroids at a dosage of 40 mg per day for the treatment of alcoholic hepatitis)
- Patient who is a candidate for a combined organ transplant
- Patient receiving other immunomodulatory therapy (such as immune checkpoint inhibitors) prior to LT
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
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Patients with severe liver disease waiting for liver transplantation (LT)
Only patients with the most frequent Liver transplantation (LT) indications will be eligible: complicated cirrhosis of hepatocellular carcinoma (HCC), acute or chronic decompensation of cirrhosis, with or without multi-visceral and fulminant hepatitis
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Samples will be collected at the finale inclusion of the day oh the LT, including one sample of Cyto-Chex BCT (4 millilitre mL) .
Same samples will also be collected after LT at days 1,3,5 and 10.
Biological data will be collected at those different times
For the creation of the biobank one samples of Ethylenediaminetetraacetic acid (EDTA) (4 millilitre (mL)), and one PAXgene® sample (2.5mL) will be collected:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Predictive score for the risk of infectious complications
Periodo de tiempo: Day 30
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The primary outcome measure will be the diagnostic performance of a predictive score for early post-Liver Transplant (LT) infectious complications occurring within 30 days after LT.
The predictive score will be derived from mHLA-DR levels measured at predefined time points (Day 0, Day 1, Day 3, Day 5, and Day 10 post-LT), the pre-transplant MELD score, and other clinical or laboratory variables significantly associated with infection risk.
The predic
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Day 30
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
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Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
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
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 69HCL25_1061
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
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Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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