NCT03713489

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2018

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

October 17, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 19, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
Last Updated

October 22, 2018

Status Verified

October 1, 2018

Enrollment Period

12 months

First QC Date

October 17, 2018

Last Update Submit

October 18, 2018

Conditions

Acute-On-Chronic Liver Failure

Keywords

acute-on-chronic liver failureplateletHepatitis B

Outcome Measures

Primary Outcomes (1)

  • 28-day transplant-free mortality

    whether participant died or not without liver transplantation

    28 days

Secondary Outcomes (1)

  • transplant-free survival time

    90 days

Study Arms (2)

Platelet transfusion group

EXPERIMENTAL

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

Procedure: platelet

standard medical treatment group

NO INTERVENTION

standard medical treatment

Interventions

plateletPROCEDURE

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.

Platelet transfusion group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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%.

You may not qualify if:

  • 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.
  • Refusal to sign the informed consent form.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Guangzhou, Guangdong, 510515, China

RECRUITING

MeSH Terms

Conditions

Acute-On-Chronic Liver FailureHepatitis B

Interventions

Platelet Count

Condition Hierarchy (Ancestors)

Liver Failure, AcuteLiver FailureHepatic InsufficiencyLiver DiseasesDigestive System DiseasesBlood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitis

Intervention Hierarchy (Ancestors)

Blood Cell CountCell CountCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisHematologic TestsPlatelet Function TestsInvestigative TechniquesCell Physiological PhenomenaBlood Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Central Study Contacts

Jinjun Chen

CONTACT

+8618588531001chjj@smu.edu.cn

Tingting Qi

CONTACT

+8615521287260tingtingqi@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Director

Study Record Dates

First Submitted

October 17, 2018

First Posted

October 19, 2018

Study Start

October 1, 2018

Primary Completion

September 30, 2019

Study Completion

September 30, 2019

Last Updated

October 22, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)