Severe Liver Injury Associated with Antineoplastic Drugs
Conditions
Interventions
Sponsors
Eligibility
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
| Measure | Time 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
Third Hospital of Hebei Medical University