Platelet Transfusion in Acute-on Chronic Liver Failure

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.

Study Overview

• Status: Recruiting
• Conditions: Acute-On-Chronic Liver Failure
• Intervention / Treatment: Other: platelet transfusion

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chen Jinjun; Phone Number: +8618588531001; Email: chjj@smu.edu.cn
• Study Contact Backup: Name: Qi Tingting; Phone Number: +8615521287260; Email: tingtingqi@126.com

Study Locations

• China
  • Fujian, China
    • Recruiting
    • Meng Chao Hepatobiliary Hospital of Fujian Medical University
    • Contact: Zuxiong Huang
  • Shanghai, China
    • Recruiting
    • Shanghai Public Health Clinical Center
    • Contact: Zhiping Qian
  • Chongqing
    • Chongqing, Chongqing, China
      • Recruiting
      • The First Affiliated Hospital of Army Medical University
      • Contact: Jie Xia
  • Guangdong
    • Guangzhou, Guangdong, China, 510515
      • Recruiting
      • Nanfang Hospital
  • Hubei
    • Shiyan, Hubei, China
      • Recruiting
      • Taihe Hospital affiliated to Hubei Medical College
      • Contact: zhongji meng
  • Hunan
    • Changsha, Hunan, China
      • Recruiting
      • Xiangya Hospital Central South University
  • Jilin
    • Changchun, Jilin, China
      • Recruiting
      • The first Affiliated Hospital of Jilin University
      • Contact: Pujun Gao
  • Xinjiang
    • Xinjiang, Xinjiang, China
      • Recruiting
      • The First Affiliated Hospital of Xinjiang Medical University
      • Contact: Xiaobo Lu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 60 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: platelet transfusion treatment	Other: platelet transfusion; when the ADP inhibition >70%, give one unit platelet tansfusion
NO_INTERVENTION: standard medical treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
28-day transplant-free mortality	whether participant died or not without liver transplantation	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
90-day transplant-free mortality	mortality without transplant in 90 day	90 days

Collaborators and Investigators

• Sponsor: Nanfang Hospital of Southern Medical University

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2019
• Primary Completion (ANTICIPATED): May 1, 2024
• Study Completion (ANTICIPATED): May 1, 2024

Study Registration Dates

• First Submitted: September 18, 2020
• First Submitted That Met QC Criteria: September 21, 2020
• First Posted (ACTUAL): September 25, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 25, 2020
• Last Update Submitted That Met QC Criteria: September 21, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Liver Failure, Acute; End Stage Liver Disease; Liver Failure; Hepatic Insufficiency; Acute-On-Chronic Liver Failure
• Other Study ID Numbers: 013 (Nahrain Medical Research Collective (NMRC))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No