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

NCT ID: NCT03281278

Last Updated: 2019-06-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-10-30
• Study Completion Date: 2018-08-13

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.

Conditions

Thrombelastography,Acute on Chronic Liver Failure, Platelet

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

standard treatment

standard medical treatment

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Nanfang Hospital

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

003

Identifier Type: -

Identifier Source: org_study_id