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

Not Applicable

• Conditions: Acute-On-Chronic Liver Failure
• Interventions: Procedure: platelet

• Registration Number: NCT03713489
• Lead Sponsor: Nanfang Hospital, Southern Medical University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-10
• Study Start: 2018-10-01
• Study First Submitted: 2018-10-17
• Study First Submitted QC: 2018-10-17
• Last Update Submitted: 2018-10-18
• Study First Posted: 2018-10-19
• Last Update Posted: 2018-10-22
• Primary Completion: 2019-09-30
• Study Completion: 2019-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Platelet transfusion group	platelet	Besides standard medical treatment, up to 9 units of platelets will be transfused per protocol within 4 weeks

Primary Outcome Measures

Name	Time	Method
28-day transplant-free mortality	28 days	whether participant died or not without liver transplantation

Secondary Outcome Measures

Name	Time	Method
transplant-free survival time	90 days	survival time without transplation

Trial Locations

Locations (1)

Hepatology Unit, Department of Infectious Diseases, Nanfang Hospital, Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China