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

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.

Study Overview

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

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510515
      • Nanfang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

chronic liver disease patients（with liver dysfunction more than 6 months） with acute liver injury[with ALT>3 ULN),AST>3NL or TB>2 ULN within 1 week before enrollment] or acute decompensation[having ascites, hepatic encephalopathy and/or bacterial infection within 1 month before enrollment].

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
28-day mortality	death within 28-day	28-day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
28-day progression	progressed to EASL defined ACLF	28-day
90-day mortality	death within 90-day	90-day

Collaborators and Investigators

• Sponsor: Nanfang Hospital of Southern Medical University

Study record dates

Study Major Dates

• Study Start (Actual): July 6, 2020
• Primary Completion (Actual): December 5, 2020
• Study Completion (Actual): December 5, 2020

Study Registration Dates

• First Submitted: December 15, 2020
• First Submitted That Met QC Criteria: December 15, 2020
• First Posted (Actual): December 19, 2020

Study Record Updates

• Last Update Posted (Actual): December 19, 2020
• Last Update Submitted That Met QC Criteria: December 15, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases
• Other Study ID Numbers: NFEC-2020-052

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No