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Platelet Transfusion in Acute-on Chronic Liver Failure

Primary Purpose

Acute-On-Chronic Liver Failure

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
platelet transfusion
Sponsored by
Nanfang Hospital, Southern Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute-On-Chronic Liver Failure

Eligibility Criteria

16 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The First Affiliated Hospital of Army Medical UniversityRecruiting
  • Nanfang HospitalRecruiting
  • Taihe Hospital affiliated to Hubei Medical CollegeRecruiting
  • Xiangya Hospital Central South UniversityRecruiting
  • The First Affiliated Hospital of Jilin UniversityRecruiting
  • The First Affiliated Hospital of Xinjiang Medical UniversityRecruiting
  • Meng Chao Hepatobiliary Hospital of Fujian Medical UniversityRecruiting
  • Shanghai Public Health Clinical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

platelet transfusion treatment

standard medical treatment

Arm Description

Outcomes

Primary Outcome Measures

28-day transplant-free mortality
whether participant died or not without liver transplantation

Secondary Outcome Measures

90-day transplant-free mortality
mortality without transplant in 90 day

Full Information

First Posted
September 18, 2020
Last Updated
September 21, 2020
Sponsor
Nanfang Hospital, Southern Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT04564651
Brief Title
Platelet Transfusion in Acute-on Chronic Liver Failure
Official Title
Platelet Transfusion in Acute-on Chronic Liver Failure
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
May 1, 2024 (Anticipated)
Study Completion Date
May 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanfang Hospital, Southern Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute-On-Chronic Liver Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
platelet transfusion treatment
Arm Type
Experimental
Arm Title
standard medical treatment
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
platelet transfusion
Intervention Description
when the ADP inhibition >70%, give one unit platelet tansfusion
Primary Outcome Measure Information:
Title
28-day transplant-free mortality
Description
whether participant died or not without liver transplantation
Time Frame
28 days
Secondary Outcome Measure Information:
Title
90-day transplant-free mortality
Description
mortality without transplant in 90 day
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chen Jinjun
Phone
+8618588531001
Email
chjj@smu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Qi Tingting
Phone
+8615521287260
Email
tingtingqi@126.com
Facility Information:
Facility Name
The First Affiliated Hospital of Army Medical University
City
Chongqing
State/Province
Chongqing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jie Xia
Facility Name
Nanfang Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jinjun Chen
Phone
+8615521287260
Email
chjj@smu.edu.cn
First Name & Middle Initial & Last Name & Degree
Tingting Qi
Phone
+8615521287260
Email
tingtingqi@126.com
Facility Name
Taihe Hospital affiliated to Hubei Medical College
City
Shiyan
State/Province
Hubei
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhongji Meng
Facility Name
Xiangya Hospital Central South University
City
Changsha
State/Province
Hunan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yan Huang
Facility Name
The First Affiliated Hospital of Jilin University
City
Changchun
State/Province
Jilin
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pujun Gao
Facility Name
The First Affiliated Hospital of Xinjiang Medical University
City
Xinjiang
State/Province
Xinjiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaobo Lu
Facility Name
Meng Chao Hepatobiliary Hospital of Fujian Medical University
City
Fujian
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zuxiong Huang
Facility Name
Shanghai Public Health Clinical Center
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhiping Qian

12. IPD Sharing Statement

Plan to Share IPD
No

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Platelet Transfusion in Acute-on Chronic Liver Failure

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