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Completed

NCT Number: NCT04675125

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.

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Key information

Conditions

Thrombelastography, Acute Liver Injury, Acute Decompensation, Platelet

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Nanfang Hospital

Guangzhou, Guangdong, 510515, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • chronic liver disease: including chronic liver hepatitis patients without cirrhosis, compensated cirrhosis patients, decompensated cirrhosis patients and non-alcoholic fatty liver disease patients.
  • 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

  • those who had hepatocellular carcinoma or other types of malignancies;
  • obstructive biliary diseases or other disease lead to bilirubin evaluation;
  • those who had acute hemorrhage one week before admission
  • those who received platelet, cryo transfusion or plasmapheresis one week before admission
  • pregnancy and breastfeeding
  • those who received liver transplantation or kidney transplantation;
  • 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)
  • readmission;
  • death within 24 hours.

Treatment and study plan

Primary outcomes

  1. 28-day mortality

    Time frame: 28-day

    death within 28-day

Secondary outcomes

  1. 28-day progression

    Time frame: 28-day

    progressed to EASL defined ACLF

  2. 90-day mortality

    Time frame: 90-day

    death within 90-day

Sponsors and collaborators

Lead sponsor

Nanfang Hospital, Southern Medical University

Other

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Dec 19, 2020
Registry last updated
Dec 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.