Platelet Transfusion in Acute-on Chronic Liver Failure
1 other identifier
interventional
80
1 country
8
Brief Summary
Acute on-chronic liver failure (ACLF) is a severe liver disease with a 28-day mortality rate of up to 40%. When the patients get 3 or more organ failures, the 28-day mortality rate is up to 82.6%. Though the ACLF patients have high short-term mortality, and the only effective treatment method is liver transplantation. However, few patients can be treated due to the scarcity of liver source, rapid disease progression and short transplantation window. Our team evaluated the platelet function of 100 patients with ACLF by using the thromboelastograghy (TEG 5000). It was found for the first time that the reactivity of platelets of ACLF patients decreased, and the platelet inhibition rate (especially the ADP pathway) was related to patients'short-term prognosis. When the ADP inhibition rate was 70%, the patients'28-day mortality was up to 100%. However, the mechanism of low platelet response to ADP in ACLF patients is still unclear. We found that the platelet function in patients with ACLF 2-3 grade and inhibition rate beyond 70% was improved and the 28-day mortality decreased after platelet transfusion. Whether platelet transfusion can prolong survival time needs to be determined in a prospective controlled study. Therefore, this study is expected to find a new therapeutic method to reduce the mortality of patients with ACLF.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2019
Longer than P75 for not_applicable
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2019
CompletedFirst Submitted
Initial submission to the registry
September 18, 2020
CompletedFirst Posted
Study publicly available on registry
September 25, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2024
CompletedSeptember 25, 2020
September 1, 2020
5 years
September 18, 2020
September 21, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
28-day transplant-free mortality
whether participant died or not without liver transplantation
28 days
Secondary Outcomes (1)
90-day transplant-free mortality
90 days
Study Arms (2)
platelet transfusion treatment
EXPERIMENTALstandard medical treatment
NO INTERVENTIONInterventions
when the ADP inhibition \>70%, give one unit platelet tansfusion
Eligibility Criteria
You may qualify if:
- years old;
- Patients with compensated cirrhosis conformed to the (ACLF) diagnostic criteria of chronic and acute liver failure defined by the European Association of Hepatology (EASL-CLIF), and met the ACLF-2 and 3 grades.
- ADP inhibition rate ≥ 70%.
You may not qualify if:
- Patients with severe platelet allergy in the past;
- Coma caused by cerebral hemorrhage or primary diseases of the nervous system;
- Those who have taken anti-platelet drugs or anticoagulants within four weeks;
- Rupture and bleeding of EVB occurred within 1 week.
- Those who received platelet transfusion within 1 week;
- Patients with liver cancer or other malignant tumors;
- Pregnant and lactating women;
- Complicated with other serious chronic diseases;
- Not signing the informed consent form;
- Other researchers do not consider it appropriate to participate in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
The First Affiliated Hospital of Army Medical University
Chongqing, Chongqing Municipality, China
Nanfang Hospital
Guangzhou, Guangdong, 510515, China
Taihe Hospital affiliated to Hubei Medical College
Shiyan, Hubei, China
Xiangya Hospital Central South University
Changsha, Hunan, China
The First Affiliated Hospital of Jilin University
Changchun, Jilin, China
The First Affiliated Hospital of Xinjiang Medical University
Xinjiang, Xinjiang, China
Meng Chao Hepatobiliary Hospital of Fujian Medical University
Fujian, China
Shanghai Public Health Clinical Center
Shanghai, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Director
Study Record Dates
First Submitted
September 18, 2020
First Posted
September 25, 2020
Study Start
May 1, 2019
Primary Completion
May 1, 2024
Study Completion
May 1, 2024
Last Updated
September 25, 2020
Record last verified: 2020-09
Data Sharing
- IPD Sharing
- Will not share