Acute-On-Chronic Liver Failure
Conditions
Keywords
acute-on-chronic liver failure, platelet, Hepatitis B
Brief summary
Acute-on-chronic liver failure (ACLF) is a syndrome that has recently been recognized as encompassing acute deterioration of liver function in patients with pre-existing chronic liver disease. It is associated with multi-organ failure and a high risk of short-term mortality. Thrombocytopenia is common in ACLF. In addition, the function of platelet is also compromised according to our previous data. The aim of this study is to explore whether platelet transfusion could reduce the short-term mortality rate of HBV-related ACLF. This is a single center, open labeled randomized controlled study. There are two arms. Subjects who is assigned to platelet transfusion group will receive both platelet transfusion (9 times/4 weeks, 1 unit each time) and standard medical treatment. While those in standard medical treatment group will receive standard medical treatment only. The major endpoint is 28-day transplant-free mortality rate.
Interventions
PROCEDUREplatelet
Participants in platelet transfusion group will receive one unit of apheresis platelets transfusion 3 times for the first week after enrollment, then 2 times a week in the following three weeks.
Sponsors
Nanfang Hospital, Southern Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-60 years old * Diagnosed with acute-on-chronic liver failure (grade-2) according to EASL-CLIF criteria and grading system. * Chronic hepatitis B infection. * ADP inhibition rate ≥70%.
Exclusion criteria
* Combined with chronic liver disease other than chronic HBV infection. * Previous decompensation. * Intracranial hemorrhage proved by radiological methods, symptoms and physical signs. * Under anti-platelet or anticoagulants therapy within 4 weeks. * Esophageal variceal bleeding within 1 week. * Platelets transfusion within 1 week. * Hepatocellular carcinoma or other types of malignancies. * Pregnancy or breastfeeding. * Severe chronic extra-hepatic disease. * Comined with situations that researchers considered not suitable for inclusion * Refusal to sign the informed consent form.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 28-day transplant-free mortality | 28 days | whether participant died or not without liver transplantation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| transplant-free survival time | 90 days | survival time without transplation |
Countries
China
Contacts
Primary ContactJinjun Chen
Backup ContactTingting Qi
Outcome results
None listed