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

NCT ID: NCT03713489

Last Updated: 2018-10-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-01
• Study Completion Date: 2019-09-30

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.

Conditions

Acute-On-Chronic Liver Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Platelet transfusion group

Besides standard medical treatment, up to 9 units of platelets will be transfused per protocol within 4 weeks

Group Type: EXPERIMENTAL

platelet

Intervention Type: PROCEDURE

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.

standard medical treatment group

standard medical treatment

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role: lead

Responsible Party

Jinjun Chen

Associate Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hepatology Unit, Department of Infectious Diseases, Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jinjun Chen

Role: CONTACT

chjj@smu.edu.cn

+8618588531001

Tingting Qi

Role: CONTACT

tingtingqi@126.com

+8615521287260

Facility Contacts

Jinjun Chen

Role: primary

chjj@smu.edu.cn

86-18588531001

Tingting Qi

Role: backup

tingtingqi@126.com

+8615521287260

Other Identifiers

008

Identifier Type: -

Identifier Source: org_study_id