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

NCT ID: NCT04119973

Last Updated: 2020-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

486 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-08-16

Study Completion Date

2019-11-04

Brief Summary

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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.

Detailed Description

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Conditions

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Thrombelastography Acute on Chronic Liver Failure Platelet Multicenter Prospective Study

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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standard treatment

standard medical treatment

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Southwest Hospital, China

OTHER

Sponsor Role collaborator

The First Hospital of Jilin University

OTHER

Sponsor Role collaborator

First Affiliated Hospital of Xinjiang Medical University

OTHER

Sponsor Role collaborator

Meng Chao Hepatobiliary Hospital of Fujian Medical University

OTHER

Sponsor Role collaborator

Xiangya Hospital of Central South University

OTHER

Sponsor Role collaborator

Taihe Hospital

OTHER

Sponsor Role collaborator

Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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

Guangzhou, Guangdong, China

Site Status

Countries

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China

Other Identifiers

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009

Identifier Type: -

Identifier Source: org_study_id

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