Clinical trial NCT04675125: A Prospective Study of Application of Platelet Mapping in Chronic Liver Disease Complicated With ALI and/or AD in China
Official title: A Prospective Study of Application of Platelet Mapping in Chronic Liver Disease Complicated With ALI and/or AD in China
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thrombelastography, Acute Liver Injury, Acute Decompensation, Platelet
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2020-12-19
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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\[having ascites, hepatic encephalopathy and/or bacterial infection within 1 month before enrollment\].

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.


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.

Primary outcomes:
measure: 28-day mortality
timeFrame: 28-day
Secondary outcomes:
measure: 28-day progression
timeFrame: 28-day
measure: 90-day mortality
timeFrame: 90-day
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Nanfang Hospital
state: Guangdong
Study officials:
References: