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

Completed

• Conditions: Thrombelastography,Acute on Chronic Liver Failure, Platelet

• Registration Number: NCT03281278
• 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. This study aims to explore the predictive role of platelet mapping in ACLF prognosis, organ failure developments and short term mortality.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-09-11
• Study First Submitted QC: 2017-09-11
• Study First Posted: 2017-09-13
• Study Start: 2017-10-30
• Status Verified: 2018-04
• Primary Completion: 2018-08-13
• Study Completion: 2018-08-13
• Last Update Submitted: 2019-06-04
• Last Update Posted: 2019-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• patient with previously diagnosed or undiagnosed HBV related chronic liver disease/cirrhosis
• INR≥1.5 and total bilirubin≥85μmol/L

Exclusion Criteria

• INR≤1.5 or total bilirubin≤85μmol/L;
• underlying chronic liver disease was other than chronic HBV infection related;
• 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
• using steroid or immunosuppressant or antiplatelet or anticoagulant drugs in 4 weeks
• any kind of decompensation which persisted over a month
• 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
90-day mortality	90-day	death within 90-day
28-day progression	28-day	progressed to EASL defined ACLF

Trial Locations

Locations (1)

Nanfang Hospital; 🇨🇳 Guangzhou, Guangdong, China