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

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

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 Overview

• Status: Unknown
• Conditions: Acute-On-Chronic Liver Failure
• Intervention / Treatment: Procedure: platelet

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510515
      • Recruiting
      • Hepatology Unit, Department of Infectious Diseases, Nanfang Hospital, Southern Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Nanfang Hospital of Southern Medical University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Anticipated): September 30, 2019
• Study Completion (Anticipated): September 30, 2019

Study Registration Dates

• First Submitted: October 17, 2018
• First Submitted That Met QC Criteria: October 17, 2018
• First Posted (Actual): October 19, 2018

Study Record Updates

• Last Update Posted (Actual): October 22, 2018
• Last Update Submitted That Met QC Criteria: October 18, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: platelet; Hepatitis B; acute-on-chronic liver failure
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Liver Failure, Acute; End Stage Liver Disease; Liver Failure; Hepatic Insufficiency; Acute-On-Chronic Liver Failure
• Other Study ID Numbers: 008 (Other Identifier: Nahrain Medical Research Collective (NMRC))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No