Acute-on-chronic liver failure (ACLF) complicated with infection-associated thrombocytopenia
Conditions
Interventions
Trial Group:Recombinant Human Thrombopoietin (rhTPO)
Sponsors
Shandong Public Health Clinical Center
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Aged 18 to 75, no gender restrictions; 2.Meet the 2025 Asian Pacific Association for the Study of the Liver (APASL) diagnostic criteria for ACLF: Acute liver failure occurring in patients with chronic liver disease or cirrhosis (TBil >5 mg/dL and INR >=1.5), accompanied by ascites and/or hepatic encephalopathy within 28 days, with or without renal dysfunction (serum creatinine >1.5 mg/dL, 1 mg/dL = 88.4 µmol/L), which is also associated with a high 28-day mortality rate; 3.Patients with thrombocytopenia complicating acute-on-chronic liver failure combined with infection; 4.Participants who agree to undergo 90-day follow-up; 5.Able to understand and willing to comply with the requirements of the clinical trial protocol, and voluntarily sign the written informed consent form;
Exclusion criteria
Exclusion criteria: 1.Persons with known hypersensitivity to rhTPO or any of its excipients; 2.Patients who have received radiotherapy targeting the bone marrow hematopoietic region within the previous 3 months, or those whose cumulative radiation dose may cause irreversible damage to bone marrow hematopoietic function; 3.Patients diagnosed with other malignant tumors (including hematological malignancies) besides primary liver cancer at the time of confirmation, whose thrombocytopenia is directly attributed to radiotherapy, chemotherapy, targeted therapy, immunotherapy for tumors, or bone marrow infiltration by tumors; 4.Patients complicated with other hematological diseases (immune thrombocytopenia (ITP), aplastic anemia, myelodysplastic syndromes, leukemia, etc.) and immune diseases (systemic lupus erythematosus, Sjögren's syndrome, etc.) that may cause thrombocytopenia; 5.Patients with thrombocytopenia caused by the use of platelet inhibitor drugs (such as aspirin, clopidogrel, ticagrelor, etc.); 6.Patients with pseudothrombocytopenia and congenital thrombocytopenia; 7.Patients who have been diagnosed with thrombosis or pre-thrombotic diseases within the past 6 months or currently (including but not limited to deep vein thrombosis, pulmonary embolism, cerebral infarction, myocardial infarction, etc.); those with baseline moderate to severe portal vein thrombosis accompanied by hemodynamic abnormalities, liver failure complicated with overt disseminated intravascular coagulation (DIC), thrombotic thrombocytopenic purpura (TTP), or confirmed hypercoagulable states (such as antiphospholipid antibody syndrome); 8.Transfusion of platelets, glucocorticoids or myelosuppressive drugs within 7 days prior to enrollment; 9.Received platelet-increasing drugs such as rhTPO, Leucogen and Interleukin-11 within 1 month prior to enrollment; 10.Patients with a history of liver transplantation; 11.Patients with combined uncontrolled severe infections (septic shock, sepsis complicated with multiple organ dysfunction) whose conditions still deteriorate after 72 hours of standardized anti-infective treatment; 12.Pregnant women and breastfeeding women; 13.Other circumstances deemed by researchers to be ineligible for inclusion in this study;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients whose platelet count reaches =75×10?/L or increases by =30×10?/L from baseline at Day 14 after the start of treatment, without receiving emergency treatment for bleeding.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Median time to platelet count recovery to >=75×10?/L.;Changes in coagulation function indicators including international normalized ratio (INR), etc.;90-day survival rate during follow-up;Changes in infection/inflammatory indicators including procalcitonin (PCT), C-reactive protein (CRP), lymphocyte count, etc.;Time to platelet count peak;Impact on liver function: Changes in alanine aminotransferase (ALT), aspartate aminotransferase (AST), albumin (ALB), and other related indicators.;Incidence of adverse events (bleeding, thrombosis, etc.);28-day transplant-free survival rate;Changes in platelet count: Absolute values and relative increases in platelet count from baseline to Day 7, Day 14, Day 21, and Day 28.; | — |
Countries
China
Contacts
Public ContactWang Can
Shandong Public Health Clinical Center
Outcome results
None listed