A Multicenter Prospective Study of Application of Platelet Mapping in Acute-on-chronic-liver Failure in China

Completed

• Conditions: Multicenter Prospective Study; Thrombelastography; Platelet; Acute on Chronic Liver Failure

• Registration Number: NCT04119973
• Lead Sponsor: Nanfang Hospital, Southern Medical University

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. 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-08-16
• Status Verified: 2019-05
• Primary Completion: 2019-08-04
• Study First Submitted: 2019-10-07
• Study First Submitted QC: 2019-10-07
• Study First Posted: 2019-10-09
• Study Completion: 2019-11-04
• Last Update Submitted: 2020-01-06
• Last Update Posted: 2020-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 486

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
28-day mortality	28-day	death within 28-day

Secondary Outcome Measures

Name	Time	Method
28-day progression	28-day	progressed to EASL defined ACLF
90-day mortality	90-day	death within 90-day

Trial Locations

Locations (1)

Hepatology Unit, Department of Infectious Diseases, Nanfang Hospital, Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China