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

NCT04119973 | Completed

• 1 other identifier: 009
• Study Type: observational
• Target: 486
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Thrombelastography; Acute on Chronic Liver Failure; Platelet; Multicenter Prospective Study

Keywords

Thrombelastography; Acute on Chronic Liver Failure; Platelet; Multicenter Prospective Study

Outcome Measures

Primary Outcomes (1)

• 28-day mortality

  death within 28-day

  28-day

Secondary Outcomes (2)

• 28-day progression

  28-day

• 90-day mortality

  90-day

Interventions

standard treatment OTHER

standard medical treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with ACLF regardless of aetiology, International Normalized Ratio (INR)≥1.5 and total bilirubin≥85μmol/L

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead
• Southwest Hospital, China: collaborator
• The First Hospital of Jilin University: collaborator
• First Affiliated Hospital of Xinjiang Medical University: collaborator
• Meng Chao Hepatobiliary Hospital of Fujian Medical University: collaborator
• Xiangya Hospital of Central South University: collaborator
• Taihe Hospital: collaborator

Study Sites (1)

Hepatology Unit, Department of Infectious Diseases, Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510515, China

Location

MeSH Terms

Conditions

Acute-On-Chronic Liver Failure

Condition Hierarchy (Ancestors)

Liver Failure, Acute; Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2019
• First Posted: October 9, 2019
• Study Start: August 16, 2018
• Primary Completion: August 4, 2019
• Study Completion: November 4, 2019
• Last Updated: January 9, 2020

Record last verified: 2019-05

Locations

CN (1)