Clinical trial NCT04564651: Platelet Transfusion in Acute-on Chronic Liver Failure
Official title: Platelet Transfusion in Acute-on Chronic Liver Failure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute-On-Chronic Liver Failure
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2020-09-25
Enrollment: 80
Sex: ALL
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 18-60 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%.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: 28-day transplant-free mortality
timeFrame: 28 days
Secondary outcomes:
measure: 90-day transplant-free mortality
timeFrame: 90 days
Other outcomes:
Locations:
city: Chongqing
country: China
facility: The First Affiliated Hospital of Army Medical University
state: Chongqing
city: Guangzhou
country: China
facility: Nanfang Hospital
state: Guangdong
city: Shiyan
country: China
facility: Taihe Hospital affiliated to Hubei Medical College
state: Hubei
city: Changsha
country: China
facility: Xiangya Hospital Central South University
state: Hunan
city: Changchun
country: China
facility: The First Affiliated Hospital of Jilin University
state: Jilin
city: Xinjiang
country: China
facility: The First Affiliated Hospital of Xinjiang Medical University
state: Xinjiang
city: Fujian
country: China
facility: Meng Chao Hepatobiliary Hospital of Fujian Medical University
city: Shanghai
country: China
facility: Shanghai Public Health Clinical Center
Study officials:
References: