Platelet Transfusion in Acute-on Chronic Liver Failure

Acute-On-Chronic Liver Failure Clinical Trial

Official title:

Platelet Transfusion in Acute-on Chronic Liver Failure

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04564651
• Other study ID #: 013
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2019
• Est. completion date: May 1, 2024

Study information

• Verified date: September 2020
• Source: Nanfang Hospital of Southern Medical University
• Contact: Chen Jinjun
• Phone: +8618588531001
• Email: chjj[@]smu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: May 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute-On-Chronic Liver Failure
• End Stage Liver Disease
• Hepatic Insufficiency
• Liver Failure

Intervention

Other:
• platelet transfusion
when the ADP inhibition >70%, give one unit platelet tansfusion

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Jilin University	Changchun	Jilin
China	Xiangya Hospital Central South University	Changsha	Hunan
China	The First Affiliated Hospital of Army Medical University	Chongqing	Chongqing
China	Meng Chao Hepatobiliary Hospital of Fujian Medical University	Fujian
China	Nanfang Hospital	Guangzhou	Guangdong
China	Shanghai Public Health Clinical Center	Shanghai
China	Taihe Hospital affiliated to Hubei Medical College	Shiyan	Hubei
China	The First Affiliated Hospital of Xinjiang Medical University	Xinjiang	Xinjiang

Sponsors (1)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	28-day transplant-free mortality	whether participant died or not without liver transplantation	28 days
Secondary	90-day transplant-free mortality	mortality without transplant in 90 day	90 days