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Plasma Exchange Half-dose and Extracorporeal Detoxification for ACLF (Phoenix)

11 de mayo de 2026 actualizado por: Tiago Bessa Gradim Loza, Unidade Local de Saude do Nordeste

Clinical trial

The goal of this clinical trial is to learn if a liver support protocol works to treat Liver failure in adults. The main questions it aims to answer are:

  • Does hemoadsorption plus half-dose plasma exchange provide support to liver failure patients until recovery or transplant
  • What medical problems do participants have during the technique? Researchers will compare DPMAS plus half-dose plasma exchange with conventional treatment to evaluate a gain in recovery

Participants will:

  • Be submitted to DPMAS plus half dose plasma exchange daily according to protocol.
  • Monitoring will be continuous in the ICU

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

Acute-on-chronic liver failure (ACLF) is a complex and life-threatening syndrome that develops when chronic liver disease suddenly decompensates. It is marked by systemic inflammation, the accumulation of albumin-bound toxins, and the rapid onset of multiorgan failure. The main drivers of this process include elevated levels of bilirubin and bile acids, an intense cytokine storm, and a profound loss of the liver's synthetic capacity.

Clinicians classify ACLF into three grades of increasing severity, with 28-day mortality ranging from 20-30% in grade 1, 40-60% in grade 2, and exceeding 70% in grade 3. Despite important advances in understanding its pathophysiology, effective therapeutic options remain limited, particularly for patients who are not candidates for liver transplantation. At present, no widely accepted extracorporeal liver support therapy has proven consistently successful. The central goal of care is therefore to stabilize the patient, control the inflammatory response and toxin burden, and create the conditions for hepatic regeneration or to serve as a bridge to transplantation.

Over the past decades, extracorporeal blood purification techniques have been explored as adjunctive therapies. High-volume plasma exchange has shown potential to reduce inflammatory mediators and improve survival in selected patients with acute liver failure or ACLF. However, its routine use is constrained by high plasma consumption, significant transfusion-related risks, and logistical challenges.

The Double Plasma Molecular Adsorption System (DPMAS), which employs the BS330 adsorber for bilirubin and bile acids and the HA330-2 adsorber for cytokines and inflammatory mediators, offers a more targeted approach. When combined with half-dose plasma exchange and appropriate replacement of plasma components, this hybrid detoxification strategy achieves effective toxin removal and immune modulation while substantially reducing the volume of plasma required. In our intensive care unit, this hybrid protocol has been developed and refined through clinical experience and informed by earlier studies. Several critically ill patients with ACLF who would otherwise have died or required urgent transplantation showed encouraging signs of recovery. Nevertheless, robust evidence from a randomized controlled trial is still needed to confirm the efficacy and safety of this combined approach in patients with ACLF of reversible aetiology.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

240

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

  • Portugal
    • Braganza District
      • Bragança, Braganza District, Portugal, 5301-852
        • Unidade Hospitalar de Bragança
        • Contacto:
        • Sub-Investigador:
          • Carla Gomes
        • Sub-Investigador:
          • Antonio Grilo Novais
        • Sub-Investigador:
          • Carla Pires
        • Sub-Investigador:
          • Raquel Leitão
        • Sub-Investigador:
          • Tiago Ceriz

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

Inclusion Criteria:

  • Written informed consent for participation in the study
  • Admission to the ICU with a diagnosis of ACLF of reversible etiology (infection, bleeding, alcohol-related, toxic, etc.)
  • Total bilirubin ≥ 12 mg/dL and INR ≥ 1.5
  • On the waiting list for liver transplantation or not a candidate for transplantation but with an indication for supportive therapy

Exclusion Criteria:

  • Refusal to provide consent
  • Pregnancy
  • Expected survival < 24 hours due to disease severity (hemodynamic instability requiring norepinephrine > 0.20 mcg/kg/min and/or mechanical ventilation with PaO₂/FiO₂ < 150 and/or non-hepatic coma)
  • ACLF severity greater than CLIF-C ACLF grade 3
  • Advanced organ dysfunction: Pulmonary (GOLD stage 3 or 4) and/or Cardiac (NYHA functional class III or IV)
  • Advanced or metastatic oncological disease (life expectancy < 6 months)
  • Marked frailty syndrome or secondary sarcopenia
  • Participation in another clinical trial within the previous 3 months

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Cuidados de apoyo
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Sin intervención: Conventional therapy
Conventional therapy to ACLF
Experimental: DPMAS plus Plasma exchange

Patients in this arm will be submitted to:

DPMAS: selective adsorption therapy; mainly removes bilirrubin and inflammatory mediators AND Half-dose plasma exchange: nonselective plasma removal and replacement by a donor
Dispositivo: DPMAS plus plasma exchange
Use of extracorporal technique to support patients with acute on chronic liver failure

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Mortality or need for liver transplantation
Periodo de tiempo: From enrollment to 28 days after
28-day mortality and/or need for liver transplantation
From enrollment to 28 days after

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Total bilirrubin level
Periodo de tiempo: Daily from date of randomization until ICU discharge or liver trasnplant up to 12 weeks
Units: mg/dL
Daily from date of randomization until ICU discharge or liver trasnplant up to 12 weeks
INR
Periodo de tiempo: Daily from date of randomization until ICU discharge or liver trasnplant up to 12 weeks
International Normalized Ratio
Daily from date of randomization until ICU discharge or liver trasnplant up to 12 weeks
SOFA
Periodo de tiempo: Daily from date of randomization until ICU discharge or liver trasnplant up to 12 weeks.
Sequential Organ Failure Assessment Score. Scale: 0-24. Higher score means worst outcome.
Daily from date of randomization until ICU discharge or liver trasnplant up to 12 weeks.
CLIF-C ACLF score
Periodo de tiempo: Measur at day of randomization, 72h after and 7 days after
Chronic Liver Failure Consortium Acute-on-Chronic Liver Failure score. Range 0-100
Measur at day of randomization, 72h after and 7 days after
Mortality or liver transplant at day 90
Periodo de tiempo: 90 days after randomization
Mortality or liver transplant at day 90 after randomization
90 days after randomization
Encephalopathy
Periodo de tiempo: Daily from date of randomization until ICU discharge or liver trasnplant up to 12 weeks
Grade of encephalopathy according West Haven score. Grade 0-4. Higher score means worst outcome.
Daily from date of randomization until ICU discharge or liver trasnplant up to 12 weeks
Vasopressor free days
Periodo de tiempo: Daily from date of randomization until ICU discharge or liver trasnplant up to 12 weeks
Number of days without need of vasopressor support
Daily from date of randomization until ICU discharge or liver trasnplant up to 12 weeks
Invasive mechanical ventilation free days
Periodo de tiempo: Daily from date of randomization until ICU discharge or liver trasnplant up to 12 weeks
Number of days without need of invasive mechanical ventilation
Daily from date of randomization until ICU discharge or liver trasnplant up to 12 weeks
CRRT free days
Periodo de tiempo: Daily from date of randomization until ICU discharge or liver trasnplant up to 12 weeks
Number of days without need of Continuous Renal Replacement Therapy
Daily from date of randomization until ICU discharge or liver trasnplant up to 12 weeks
Safety issues - bleeding events
Periodo de tiempo: Daily from date of randomization until ICU discharge or liver trasnplant up to 12 weeks
Bleeding events will be recorded and classified as major bleeding, clinically relevant non-major bleeding or minor bleeding according to standard critical care definitions. Assessment will include overt hemorrhage, intracranial bleeding, gastrointestinal bleeding, procedure-related bleeding, transfusion requirements and decreases in hemoglobin levels.
Daily from date of randomization until ICU discharge or liver trasnplant up to 12 weeks
Safety issues - Coagulation Abnormalities
Periodo de tiempo: Daily from date of randomization until ICU discharge or liver trasnplant up to 12 weeks
Serial coagulation monitoring will include INR, fibrinogen concentration, platelet count and activated clotting parameters when applicable. Development or worsening of coagulopathy during DPMAS or plasma exchange sessions will be documented.
Daily from date of randomization until ICU discharge or liver trasnplant up to 12 weeks
Safety issues - Hemodynamic Instability
Periodo de tiempo: Daily from date of randomization until ICU discharge or liver trasnplant up to 12 weeks
Episodes of hypotension during or after extracorporeal therapy sessions will be recorded, including increases in vasopressor requirements, reduction in mean arterial pressure, arrhythmias or interruption of treatment due to cardiovascular instability.
Daily from date of randomization until ICU discharge or liver trasnplant up to 12 weeks
Safety issues - Circuit-Related Complications
Periodo de tiempo: Daily from date of randomization until ICU discharge or liver trasnplant up to 12 weeks
Extracorporeal circuit complications will include filter clotting, premature circuit failure, interruption of therapy, vascular access dysfunction, catheter thrombosis and technical complications related to DPMAS or plasma exchange delivery
Daily from date of randomization until ICU discharge or liver trasnplant up to 12 weeks
Safety issues - Metabolic and Electrolyte Disturbance
Periodo de tiempo: Daily from date of randomization until ICU discharge or liver trasnplant up to 12 weeks
Metabolic complications including acid-base disturbances, electrolyte abnormalities and clinically significant metabolic derangements occurring during therapy will be recorded
Daily from date of randomization until ICU discharge or liver trasnplant up to 12 weeks
Safety issues - Hematologic Complications
Periodo de tiempo: Daily from date of randomization until ICU discharge or liver trasnplant up to 12 weeks
Development of thrombocytopenia, hemolysis or significant transfusion requirements associated with extracorporeal therapy will be assessed throughout treatment and follow-up.
Daily from date of randomization until ICU discharge or liver trasnplant up to 12 weeks
Safety issues - Infectious Complications
Periodo de tiempo: Daily from date of randomization until ICU discharge or liver trasnplant up to 12 weeks
New infections, catheter-related bloodstream infections, bacteremia and sepsis episodes occurring during treatment or ICU stay will be documented.
Daily from date of randomization until ICU discharge or liver trasnplant up to 12 weeks
Safety issues - Renal Complications
Periodo de tiempo: Daily from date of randomization until ICU discharge or liver trasnplant up to 12 weeks
Renal outcomes will include development or worsening of acute kidney injury, need for renal replacement therapy and renal replacement therapy-free days.
Daily from date of randomization until ICU discharge or liver trasnplant up to 12 weeks
Safety issues - Neurological Complications
Periodo de tiempo: Daily from date of randomization until ICU discharge or liver trasnplant up to 12 weeks
Neurological adverse events including worsening hepatic encephalopathy, seizures, cerebral edema or unexplained neurological deterioration will be monitored and documented.
Daily from date of randomization until ICU discharge or liver trasnplant up to 12 weeks

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Unidade Local de Saude do Nordeste

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de julio de 2026

Finalización primaria (Estimado)

1 de diciembre de 2027

Finalización del estudio (Estimado)

1 de enero de 2028

Fechas de registro del estudio

Enviado por primera vez

30 de abril de 2026

Primero enviado que cumplió con los criterios de control de calidad

11 de mayo de 2026

Publicado por primera vez (Actual)

18 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

18 de mayo de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

11 de mayo de 2026

Última verificación

1 de abril de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • Phoenix

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

Data available upon reasonable request always with anonymity

Marco de tiempo para compartir IPD

End date

Criterios de acceso compartido de IPD

For investigational use

Tipo de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO
  • SAVIA
  • CIF
  • RSC

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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