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NCT Number: NCT04119973

A Multicenter Prospective Study of Application of Platelet Mapping in Acute-on-chronic-liver Failure 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. And through the platelet mapping, it can help provide a picture of patients' function of platelet. Based on the primary result of our derivation cohort(NCT03281278), ACLF patients with high ADP inhibition rate had high 28-day mortality.This multicenter validation cohort aims to validate the predictive role of platelet mapping in ACLF prognosis, organ failure developments and short term mortality.

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Key information

Conditions

Thrombelastography Acute on Chronic Liver Failure Acute-On-Chronic Liver Failure Digestive System Diseases Hepatic Insufficiency Liver Diseases Liver Failure Liver Failure, Acute Multicenter Prospective Study Platelet

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hepatology Unit, Department of Infectious Diseases, Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510515, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • INR≥1.5 and total bilirubin≥85μmol/L

Exclusion criteria

  • INR≤1.5 or total bilirubin≤85μmol/L;
  • 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

standard treatment

Other

standard medical treatment

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

Collaborators

  • First Affiliated Hospital of Xinjiang Medical University
  • Meng Chao Hepatobiliary Hospital of Fujian Medical University
  • Southwest Hospital, China
  • Taihe Hospital
  • The First Hospital of Jilin University
  • Xiangya Hospital of Central South University

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 9, 2019
Registry last updated
Jan 9, 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.

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