A Prospective Study of Application of Platelet Mapping in Chronic Liver Disease Complicated With ALI and/or AD in China

Thrombelastography, Acute Liver Injury, Acute Decompensation, Platelet Clinical Trial

Official title:

A Prospective Study of Application of Platelet Mapping in Chronic Liver Disease Complicated With ALI and/or AD in China

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04675125
• Other study ID #: NFEC-2020-052
• Status: Completed
• Start date: July 6, 2020
• Est. completion date: December 5, 2020

Study information

• Verified date: July 2020
• Source: Nanfang Hospital of Southern Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Ineffective hemostasis or a paradoxical prothrombotic state of Acute-on-chronic liver disease (ACLF) has been well established. Thrombelastography measures the dynamics of thrombin production and provides a global assessment of coagulation incorporating the cumulative effect of the interactions at various levels between plasma components and cellular component of coagulation. Through the previous studies(NCT03281278 and NCT04119973), we found that ACLF patients with high ADP inhibition rate had high 28-day mortality.This study aims to validate that high ADP inhibition rate only occurs in patients with liver failure and is related to the severity of the disease.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 5, 2020
• Est. primary completion date: December 5, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. chronic liver disease: including chronic liver hepatitis patients without cirrhosis, compensated cirrhosis patients, decompensated cirrhosis patients and non-alcoholic fatty liver disease patients.

2. ALI(acute liver injury): including [ALT > 3 ULN(upper limited of normal),AST > 3 ULN or TB > 2 ULN within 1 week before enrollment] or AD(acute decompensation) : including [(having ascites, hepatic encephalopathy and/or bacterial infection within 1 month before enrollment)].

Exclusion Criteria:

1. those who had hepatocellular carcinoma or other types of malignancies;

2. obstructive biliary diseases or other disease lead to bilirubin evaluation;

3. those who had acute hemorrhage one week before admission

4. those who received platelet, cryo transfusion or plasmapheresis one week before admission

5. pregnancy and breastfeeding

6. those who received liver transplantation or kidney transplantation;

7. combine with other disease lead to organ failure including heart failure (NYHA IV),respiratory failure(PaO2<60mmHg),renal insufficiency(CKD 5) and conscious disturbance (GCS<8)

8. readmission;

9. death within 24 hours.

Related Conditions & MeSH terms

• Liver Diseases
• Thrombelastography, Acute Liver Injury, Acute Decompensation, Platelet

Locations

Country	Name	City	State
China	Nanfang Hospital	Guangzhou	Guangdong

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 mortality	death within 28-day	28-day
Secondary	28-day progression	progressed to EASL defined ACLF	28-day
Secondary	90-day mortality	death within 90-day	90-day