Platelet Transfusion in HBV-related acute-on Chronic Liver Failure: a Randomized Controlled Study
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- 28-day transplant-free mortality
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
standard medical treatment group
standard medical treatment
Platelet transfusion group
Besides standard medical treatment, up to 9 units of platelets will be transfused per protocol within 4 weeks
Intervention: platelet (Procedure)
Outcomes
Primary Outcomes
28-day transplant-free mortality
Time Frame: 28 days
whether participant died or not without liver transplantation
Secondary Outcomes
- transplant-free survival time(90 days)
Investigators
Jinjun Chen
Associate Director
Nanfang Hospital, Southern Medical University