A Prospective Study of Evaluation of Minor Bleeding and Utility of Bleeding Criteria in Acute-on-chronic Liver Failure Patients in China
- Conditions
- Liver Failure, Acute on ChronicHemostatic Disorder
- Registration Number
- NCT03281252
- 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. However, the minor and major bleeding events has not been described yet. We observe the patients' major and minor bleeding events and use 4 criteria, which include BARC, ISTH, TIMI, Gusto ,to evaluate the incident rate of bleeding events in ACLF patients and pre-ACLF patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
- patient with previously or undiagnosed chronic liver disease/cirrhosis;
- serum bilirubin higher than 3 mg/dl (51 mmol/L) or ALT>10ULN（male 300 U/L; female 200 U/L)
Exclusion Criteria
- those who had or been diagnosed hepatocellular carcinoma or other types of malignancies;
- pregnancy;
- obstructive biliary diseases or other disease lead to bilirubin evaluation;
- using steroid or immunosuppressant in 4 weeks;
- prior surgeries including splenectomy，subtotal splenectomy and disconnection，liver 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)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 28-day progression 28-day progressed to EASL or APASL defined ACLF or death
- Secondary Outcome Measures
Name Time Method major bleeding event 90-day major bleeding event happen
28-day mortality 28-day death within 28 days
Trial Locations
- Locations (1)
Nanfang Hospital
🇨🇳Guangzhou, Guangdong, China