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

Hemostatic Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03281252
• Other study ID #: 001
• Status: Recruiting
• Phase: N/A
• First received: September 11, 2017
• Last updated: September 11, 2017
• Start date: April 16, 2017
• Est. completion date: September 16, 2017

Study information

• Verified date: July 2017
• Source: Nanfang Hospital of Southern Medical University
• Contact: Jinjun Chen, PHD
• Phone: 0086-18588531001
• Email: chjj[@]smu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 16, 2017
• Est. primary completion date: September 16, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Acute-On-Chronic Liver Failure
• Blood Coagulation Disorders
• End Stage Liver Disease
• Hemorrhage
• Hemostatic Disorder
• Hemostatic Disorders
• Liver Failure
• Liver Failure, Acute
• Liver Failure, Acute on Chronic

Locations

Country	Name	City	State
China	Nanfang Hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	28-day progression	progressed to EASL or APASL defined ACLF or death	28-day
Secondary	major bleeding event	major bleeding event happen	90-day
Secondary	28-day mortality	death within 28 days	28-day