NCT03281278CompletedNot Applicable
A Prospective Study of Application of Platelet Mapping in HBV-related Acute-on-chronic-liver Failure in China
Nanfang Hospital, Southern Medical University1 site in 1 country100 target enrollmentStarted: October 30, 2017Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- 28-day mortality
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
28-day mortality
Time Frame: 28-day
death within 28-day
Secondary Outcomes
- 90-day mortality(90-day)
- 28-day progression(28-day)
Investigators
Study Sites (1)
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