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

11. Mai 2026 aktualisiert von: 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

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

240

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Unterstützende Pflege
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Kein Eingriff: 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
Gerät: DPMAS plus plasma exchange
Use of extracorporal technique to support patients with acute on chronic liver failure

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Mortality or need for liver transplantation
Zeitfenster: From enrollment to 28 days after
28-day mortality and/or need for liver transplantation
From enrollment to 28 days after

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Total bilirrubin level
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 90 days after randomization
Mortality or liver transplant at day 90 after randomization
90 days after randomization
Encephalopathy
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Unidade Local de Saude do Nordeste

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Juli 2026

Primärer Abschluss (Geschätzt)

1. Dezember 2027

Studienabschluss (Geschätzt)

1. Januar 2028

Studienanmeldedaten

Zuerst eingereicht

30. April 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

11. Mai 2026

Zuerst gepostet (Tatsächlich)

18. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

18. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

11. Mai 2026

Zuletzt verifiziert

1. April 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • Phoenix

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

Data available upon reasonable request always with anonymity

IPD-Sharing-Zeitrahmen

End date

IPD-Sharing-Zugriffskriterien

For investigational use

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL
  • SAFT
  • ICF
  • CSR

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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