Platelet Transfusion in HBV-related acute-on Chronic Liver Failure

Study Overview
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Brief Summary
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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.

Official Title
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Platelet Transfusion in HBV-related acute-on Chronic Liver Failure: a Randomized Controlled Study

Conditions
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Acute-On-Chronic Liver Failure

Intervention / Treatment
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* Procedure: platelet


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Platelet transfusion group<br>Besides standard medical treatment, up to 9 units of platelets will be transfused per protocol within 4 weeks | Procedure: platelet<br>* 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.<br>|
| No Intervention: standard medical treatment group<br>standard medical treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 28-day transplant-free mortality | whether participant died or not without liver transplantation | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| transplant-free survival time | survival time without transplation | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acute-on-chronic liver failure, platelet, Hepatitis B