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

NCT03713489 — Not applicable, Unknown, 20 participants, Nanfang Hospital, Southern Medical University

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

Registry	NCT03713489
Status	Unknown
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	20 (Estimated)
Sponsor	Nanfang Hospital, Southern Medical University (Other)
Conditions	Acute-On-Chronic Liver Failure
Interventions	platelet (Procedure)
Dates	start 2018-10-01, primary completion 2019-09-30 (estimated), completion 2019-09-30 (estimated), first posted 2018-10-19, last updated 2018-10-22
Locations	1 site in China

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Platelet transfusion group	Experimental	Procedure: platelet	Besides standard medical treatment, up to 9 units of platelets will be transfused per protocol within 4 weeks
standard medical treatment group	No intervention		standard medical treatment

platelet (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.

+Outcome measures

Primary outcomes

28-day transplant-free mortality [28 days]: whether participant died or not without liver transplantation

Secondary outcomes

transplant-free survival time [90 days]: survival time without transplation

+Eligibility

Sex: All, ages: 18 Years to 60 Years

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.

+Locations (1)

Facility	City	Country	Status
Hepatology Unit, Department of Infectious Diseases, Nanfang Hospital, Southern Medical University	Guangzhou, Guangdong	China	Recruiting