A Multicenter Prospective Study of Application of Platelet Mapping in Acute-on-chronic-liver Failure in China

Acute on Chronic Liver Failure Clinical Trial

Official title:

A Multicenter Prospective Study of Application of Platelet Mapping in Acute-on-chronic-liver Failure in China

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04119973
• Other study ID #: 009
• Status: Completed
• Start date: August 16, 2018
• Est. completion date: November 4, 2019

Study information

• Verified date: May 2019
• Source: Nanfang Hospital of Southern Medical University
• Contact: n/a
• 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. 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. Based on the primary result of our derivation cohort(NCT03281278), ACLF patients with high ADP inhibition rate had high 28-day mortality.This multicenter validation cohort aims to validate the predictive role of platelet mapping in ACLF prognosis, organ failure developments and short term mortality.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 486
• Est. completion date: November 4, 2019
• Est. primary completion date: August 4, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• INR=1.5 and total bilirubin=85µmol/L

Exclusion Criteria:

• INR=1.5 or total bilirubin=85µmol/L;

• 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

• 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.

Related Conditions & MeSH terms

• Acute on Chronic Liver Failure
• Acute-On-Chronic Liver Failure
• End Stage Liver Disease
• Hepatic Insufficiency
• Liver Failure
• Multicenter Prospective Study
• Platelet
• Thrombelastography

Intervention

Other:
• standard treatment
standard medical treatment

Locations

Country	Name	City	State
China	Hepatology Unit, Department of Infectious Diseases, Nanfang Hospital, Southern Medical University	Guangzhou	Guangdong

Sponsors (7)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University	First Affiliated Hospital of Xinjiang Medical University, First Hospital of Jilin University, Mengchao Hepatobiliary Hospital of Fujian Medical University, Southwest Hospital, China, Taihe Hospital, Xiangya Hospital of Central South University

Country where clinical trial is conducted

China, 

Outcome

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