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

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ClinicalTrials.gov Identifier: NCT03713489
Recruitment Status : Recruiting
First Posted : October 19, 2018
Last Update Posted : October 22, 2018
Sponsor:
Information provided by (Responsible Party):
Jinjun Chen, Nanfang Hospital of 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.

Condition or disease Intervention/treatment Phase
Acute-On-Chronic Liver Failure Procedure: platelet Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Platelet Transfusion in HBV-related acute-on Chronic Liver Failure: a Randomized Controlled Study
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 28-day transplant-free mortality [ Time Frame: 28 days ]
    whether participant died or not without liver transplantation


Secondary Outcome Measures :
  1. transplant-free survival time [ Time Frame: 90 days ]
    survival time without transplation



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03713489


Contacts
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Contact: Jinjun Chen +8618588531001 chjj@smu.edu.cn
Contact: Tingting Qi +8615521287260 tingtingqi@126.com

Locations
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China, Guangdong
Hepatology Unit, Department of Infectious Diseases, Nanfang Hospital, Southern Medical University Recruiting
Guangzhou, Guangdong, China, 510515
Contact: Jinjun Chen    86-18588531001    chjj@smu.edu.cn   
Contact: Tingting Qi    +8615521287260    tingtingqi@126.com   
Sponsors and Collaborators
Nanfang Hospital of Southern Medical University

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Responsible Party: Jinjun Chen, Associate Director, Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier: NCT03713489     History of Changes
Other Study ID Numbers: 008
First Posted: October 19, 2018    Key Record Dates
Last Update Posted: October 22, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jinjun Chen, Nanfang Hospital of Southern Medical University:
acute-on-chronic liver failure
platelet
Hepatitis B

Additional relevant MeSH terms:
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Liver Failure
Hepatic Insufficiency
End Stage Liver Disease
Acute-On-Chronic Liver Failure
Liver Diseases
Digestive System Diseases
Liver Failure, Acute