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A Multicenter Study on the Efficacy of Double Plasma Molecular Adsorption System (DPMAS) Combined with Low-Volume Plasma Exchange (LPE) in the Treatment of Severe Liver Injury Associated with Antineoplastic Drugs

A Multicenter Study on the Efficacy of Double Plasma Molecular Adsorption System (DPMAS) Combined with Low-Volume Plasma Exchange (LPE) in the Treatment of Severe Liver Injury Associated with Antineoplastic Drugs

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500104770
Enrollment
Unknown
Registered
2025-06-23
Start date
2025-03-06
Completion date
Unknown
Last updated
2025-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe Liver Injury Associated with Antineoplastic Drugs

Interventions

DPMAS+LPE treatment group:None

Sponsors

Third Hospital of Hebei Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Understand the research procedures and voluntarily sign the informed consent form, willingly participate in this study; (2) Age between 18 and 80 years old, regardless of gender; (3) The subject is diagnosed with malignant tumor and has received antitumor drug treatment (with the last treatment within the past 3 months); (4) The presence of hyperbilirubinemia or manifestations of liver failure/pre-liver failure, with liver function and coagulation profile meeting one of the following criteria: a. Serum total bilirubin (TBil) >=5×ULN, or an increase of >=17.1µmol/L per day; b. Prothrombin activity (PTA) 1.5; (5) Patients with malignant tumors should have an expected overall survival of more than 12 weeks and a willingness to undergo active treatment.

Exclusion criteria

Exclusion criteria: (1)The subject is currently participating in other clinical interventional studies; (2) Individuals with a history of allergic reactions to extracorporeal circulation circuits, blood purification devices, or medications such as heparin and protamine; (3) Individuals with severe heart, lung, or kidney diseases; (4) Patients with a confirmed diagnosis of obstructive jaundice; (5) Patients with hemodynamic instability, circulatory failure, DIC, or active bleeding; (6) Patients with unstable myocardial infarction or cerebral infarction; (7) Individuals with mental disorders or a history thereof, or drug abusers; (8) Women who are pregnant or breastfeeding; (9) Concurrent use of other blood purification therapies that may affect efficacy observation, as well as individuals deemed unsuitable for inclusion by the investigator.

Design outcomes

Primary

MeasureTime frame
liver function;blood routine examination;blood coagulation;blood ammonia;skin reaction factor;MELD Score;28-day liver transplant-free survival rate;90-day liver transplant-free survival rate;

Countries

China

Contacts

Public ContactNa Fu

Third Hospital of Hebei Medical University

funa418@163.com+86 185 3311 2258

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026