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

11. mai 2026 oppdatert av: 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

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

240

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Portugal
    • Braganza District
      • Bragança, Braganza District, Portugal, 5301-852
        • Unidade Hospitalar de Bragança
        • Ta kontakt med:
        • Underetterforsker:
          • Carla Gomes
        • Underetterforsker:
          • Antonio Grilo Novais
        • Underetterforsker:
          • Carla Pires
        • Underetterforsker:
          • Raquel Leitão
        • Underetterforsker:
          • Tiago Ceriz

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Ingen inngripen: Conventional therapy
Conventional therapy to ACLF
Eksperimentell: 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
Enhet: DPMAS plus plasma exchange
Use of extracorporal technique to support patients with acute on chronic liver failure

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Mortality or need for liver transplantation
Tidsramme: From enrollment to 28 days after
28-day mortality and/or need for liver transplantation
From enrollment to 28 days after

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Total bilirrubin level
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 90 days after randomization
Mortality or liver transplant at day 90 after randomization
90 days after randomization
Encephalopathy
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Unidade Local de Saude do Nordeste

Publikasjoner og nyttige lenker

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Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. juli 2026

Primær fullføring (Antatt)

1. desember 2027

Studiet fullført (Antatt)

1. januar 2028

Datoer for studieregistrering

Først innsendt

30. april 2026

Først innsendt som oppfylte QC-kriteriene

11. mai 2026

Først lagt ut (Faktiske)

18. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

18. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

11. mai 2026

Sist bekreftet

1. april 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • Phoenix

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

Data available upon reasonable request always with anonymity

IPD-delingstidsramme

End date

Tilgangskriterier for IPD-deling

For investigational use

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • ICF
  • CSR

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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