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

NCT ID: NCT04675125

Last Updated: 2020-12-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-07-06
• Study Completion Date: 2020-12-05

Brief 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.

Conditions

Thrombelastography, Acute Liver Injury, Acute Decompensation, Platelet

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Nanfang Hospital

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

NFEC-2020-052

Identifier Type: -

Identifier Source: org_study_id