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

Primary Purpose

Acute-On-Chronic Liver Failure

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
platelet
Sponsored by
Nanfang Hospital, Southern Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute-On-Chronic Liver Failure focused on measuring acute-on-chronic liver failure, platelet, Hepatitis B

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hepatology Unit, Department of Infectious Diseases, Nanfang Hospital, Southern Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Platelet transfusion group

standard medical treatment group

Arm Description

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

standard medical treatment

Outcomes

Primary Outcome Measures

28-day transplant-free mortality
whether participant died or not without liver transplantation

Secondary Outcome Measures

transplant-free survival time
survival time without transplation

Full Information

First Posted
October 17, 2018
Last Updated
October 18, 2018
Sponsor
Nanfang Hospital, Southern Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03713489
Brief Title
Platelet Transfusion in HBV-related acute-on Chronic Liver Failure
Official Title
Platelet Transfusion in HBV-related acute-on Chronic Liver Failure: a Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
September 30, 2019 (Anticipated)
Study Completion Date
September 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanfang Hospital, Southern Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute-On-Chronic Liver Failure
Keywords
acute-on-chronic liver failure, platelet, Hepatitis B

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Platelet transfusion group
Arm Type
Experimental
Arm Description
Besides standard medical treatment, up to 9 units of platelets will be transfused per protocol within 4 weeks
Arm Title
standard medical treatment group
Arm Type
No Intervention
Arm Description
standard medical treatment
Intervention Type
Procedure
Intervention Name(s)
platelet
Intervention Description
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.
Primary Outcome Measure Information:
Title
28-day transplant-free mortality
Description
whether participant died or not without liver transplantation
Time Frame
28 days
Secondary Outcome Measure Information:
Title
transplant-free survival time
Description
survival time without transplation
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jinjun Chen
Phone
+8618588531001
Email
chjj@smu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Tingting Qi
Phone
+8615521287260
Email
tingtingqi@126.com
Facility Information:
Facility Name
Hepatology Unit, Department of Infectious Diseases, Nanfang Hospital, Southern Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jinjun Chen
Phone
86-18588531001
Email
chjj@smu.edu.cn
First Name & Middle Initial & Last Name & Degree
Tingting Qi
Phone
+8615521287260
Email
tingtingqi@126.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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