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

11 maggio 2026 aggiornato da: 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

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Stimato)

240

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Portogallo
    • Braganza District
      • Bragança, Braganza District, Portogallo, 5301-852
        • Unidade Hospitalar de Bragança
        • Contatto:
        • Sub-investigatore:
          • Carla Gomes
        • Sub-investigatore:
          • Antonio Grilo Novais
        • Sub-investigatore:
          • Carla Pires
        • Sub-investigatore:
          • Raquel Leitão
        • Sub-investigatore:
          • Tiago Ceriz

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Nessun intervento: Conventional therapy
Conventional therapy to ACLF
Sperimentale: 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

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Mortality or need for liver transplantation
Lasso di tempo: From enrollment to 28 days after
28-day mortality and/or need for liver transplantation
From enrollment to 28 days after

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Total bilirrubin level
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 90 days after randomization
Mortality or liver transplant at day 90 after randomization
90 days after randomization
Encephalopathy
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Unidade Local de Saude do Nordeste

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 luglio 2026

Completamento primario (Stimato)

1 dicembre 2027

Completamento dello studio (Stimato)

1 gennaio 2028

Date di iscrizione allo studio

Primo inviato

30 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

11 maggio 2026

Primo Inserito (Effettivo)

18 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

18 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

11 maggio 2026

Ultimo verificato

1 aprile 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • Phoenix

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

Data available upon reasonable request always with anonymity

Periodo di condivisione IPD

End date

Criteri di accesso alla condivisione IPD

For investigational use

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA
  • ICF
  • RSI

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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