Thrombelastography,Acute on Chronic Liver Failure, Platelet Clinical Trial
Official title:
A Prospective Study of Application of Platelet Mapping in HBV-related Acute-on-chronic-liver Failure in China
| NCT number | NCT03281278 |
| Other study ID # | 003 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | October 30, 2017 |
| Est. completion date | August 13, 2018 |
| Verified date | April 2018 |
| Source | Nanfang Hospital of Southern Medical University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 100 |
| Est. completion date | August 13, 2018 |
| Est. primary completion date | August 13, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 80 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| China | Nanfang Hospital | Guangzhou | Guangdong |
| Lead Sponsor | Collaborator |
|---|---|
| Nanfang Hospital of Southern Medical University |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 28-day mortality | death within 28-day | 28-day | |
| Secondary | 28-day progression | progressed to EASL defined ACLF | 28-day | |
| Secondary | 90-day mortality | death within 90-day | 90-day |