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

Acute-On-Chronic Liver Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03713489
• Other study ID #: 008
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: September 30, 2019

Study information

• Verified date: October 2018
• Source: Nanfang Hospital of Southern Medical University
• Contact: Jinjun Chen
• Phone: +8618588531001
• Email: chjj[@]smu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: September 30, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute-On-Chronic Liver Failure
• End Stage Liver Disease
• Liver Failure

Intervention

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.

Locations

Country	Name	City	State
China	Hepatology Unit, Department of Infectious Diseases, Nanfang Hospital, Southern Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	28-day transplant-free mortality	whether participant died or not without liver transplantation	28 days
Secondary	transplant-free survival time	survival time without transplation	90 days