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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04675125
Enrollment
200
Registered
2020-12-19
Start date
2020-07-06
Completion date
2020-12-05
Last updated
2020-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thrombelastography, Acute Liver Injury, Acute Decompensation, Platelet

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.

Interventions

None listed

Sponsors

Nanfang Hospital, Southern Medical University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
28-day mortality28-daydeath within 28-day

Secondary

MeasureTime frameDescription
28-day progression28-dayprogressed to EASL defined ACLF
90-day mortality90-daydeath within 90-day

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026