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

Completed

• Conditions: Thrombelastography, Acute Liver Injury, Acute Decompensation, Platelet

• Registration Number: NCT04675125
• Lead Sponsor: Nanfang Hospital, Southern Medical University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-07
• Study Start: 2020-07-06
• Primary Completion: 2020-12-05
• Study Completion: 2020-12-05
• Study First Submitted: 2020-12-15
• Study First Submitted QC: 2020-12-15
• Last Update Submitted: 2020-12-15
• Study First Posted: 2020-12-19
• Last Update Posted: 2020-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
28-day mortality	28-day	death within 28-day

Secondary Outcome Measures

Name	Time	Method
28-day progression	28-day	progressed to EASL defined ACLF
90-day mortality	90-day	death within 90-day

Trial Locations

Locations (1)

Nanfang Hospital; 🇨🇳 Guangzhou, Guangdong, China