Platelet Transfusion in Acute-on Chronic Liver Failure

Sponsor
Nanfang Hospital of Southern Medical University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04564651
Collaborator
(none)
80
8
2
60
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: platelet transfusion
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Platelet Transfusion in Acute-on Chronic Liver Failure
Actual Study Start Date :
May 1, 2019
Anticipated Primary Completion Date :
May 1, 2024
Anticipated Study Completion Date :
May 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 28-day transplant-free mortality [28 days]

    whether participant died or not without liver transplantation

Secondary Outcome Measures

  1. 90-day transplant-free mortality [90 days]

    mortality without transplant in 90 day

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 The First Affiliated Hospital of Army Medical University Chongqing Chongqing China
2 Nanfang Hospital Guangzhou Guangdong China 510515
3 Taihe Hospital affiliated to Hubei Medical College Shiyan Hubei China
4 Xiangya Hospital Central South University Changsha Hunan China
5 The First Affiliated Hospital of Jilin University Changchun Jilin China
6 The First Affiliated Hospital of Xinjiang Medical University Xinjiang Xinjiang China
7 Meng Chao Hepatobiliary Hospital of Fujian Medical University Fujian China
8 Shanghai Public Health Clinical Center Shanghai China

Sponsors and Collaborators

  • Nanfang Hospital of Southern Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jinjun Chen, Associate Director, Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier:
NCT04564651
Other Study ID Numbers:
  • 013
First Posted:
Sep 25, 2020
Last Update Posted:
Sep 25, 2020
Last Verified:
Sep 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 25, 2020