A Prospective Study of Evaluation of Minor Bleeding and Utility of Bleeding Criteria in Acute-on-chronic Liver Failure Patients in China

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.

Study Overview

• Status: Unknown
• Conditions: Hemostatic Disorder; Liver Failure, Acute on Chronic

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510515
      • Recruiting
      • Nanfang Hospital
      • Contact: Aishan Su; Phone Number: 02064786845; Email: nfyyqx@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

pre-acute-on-chronic liver failure and acute-on-chronic liver failure

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
28-day progression	progressed to EASL or APASL defined ACLF or death	28-day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
major bleeding event	major bleeding event happen	90-day
28-day mortality	death within 28 days	28-day

Collaborators and Investigators

• Sponsor: Nanfang Hospital of Southern Medical University

Study record dates

Study Major Dates

• Study Start (Actual): April 16, 2017
• Primary Completion (Anticipated): September 16, 2017
• Study Completion (Anticipated): September 16, 2017

Study Registration Dates

• First Submitted: September 11, 2017
• First Submitted That Met QC Criteria: September 11, 2017
• First Posted (Actual): September 13, 2017

Study Record Updates

• Last Update Posted (Actual): September 13, 2017
• Last Update Submitted That Met QC Criteria: September 11, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: liver failure
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Hematologic Diseases; Liver Diseases; Hemorrhagic Disorders; End Stage Liver Disease; Liver Failure; Hepatic Insufficiency; Acute-On-Chronic Liver Failure; Hemostatic Disorders; Blood Coagulation Disorders; Hemorrhage; Liver Failure, Acute
• Other Study ID Numbers: 001 (Buy Pharma Ecza Deposu San. Tic. Ltd.)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No