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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03281278
Recruitment Status : Completed
First Posted : September 13, 2017
Last Update Posted : June 6, 2019
Sponsor:
Information provided by (Responsible Party):
Nanfang Hospital of Southern Medical University

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. This study aims to explore the predictive role of platelet mapping in ACLF prognosis, organ failure developments and short term mortality.

Condition or disease Intervention/treatment
Thrombelastography,Acute on Chronic Liver Failure, Platelet Other: standard treatment

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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Study of Application of Platelet Mapping in HBV-related Acute-on-chronic-liver Failure in China
Actual Study Start Date : October 30, 2017
Actual Primary Completion Date : August 13, 2018
Actual Study Completion Date : August 13, 2018

Intervention Details:
  • Other: standard treatment
    standard medical treatment


Primary Outcome Measures :
  1. 28-day mortality [ Time Frame: 28-day ]
    death within 28-day


Secondary Outcome Measures :
  1. 28-day progression [ Time Frame: 28-day ]
    progressed to EASL defined ACLF

  2. 90-day mortality [ Time Frame: 90-day ]
    death within 90-day



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with HBV-related chronic liver disease, International Normalized Ratio (INR)≥1.5 and total bilirubin≥85μmol/L
Criteria

Inclusion Criteria:

  • patient with previously diagnosed or undiagnosed HBV related chronic liver disease/cirrhosis
  • INR≥1.5 and total bilirubin≥85μmol/L

Exclusion Criteria:

  • INR≤1.5 or total bilirubin≤85μmol/L;
  • underlying chronic liver disease was other than chronic HBV infection related;
  • 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
  • using steroid or immunosuppressant or antiplatelet or anticoagulant drugs in 4 weeks
  • any kind of decompensation which persisted over a month
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03281278


Locations
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China, Guangdong
Nanfang Hospital
Guangzhou, Guangdong, China, 510515
Sponsors and Collaborators
Nanfang Hospital of Southern Medical University
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Responsible Party: Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier: NCT03281278    
Other Study ID Numbers: 003
First Posted: September 13, 2017    Key Record Dates
Last Update Posted: June 6, 2019
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nanfang Hospital of Southern Medical University:
Thrombelastography,acute on chronic liver failure, platelet
Additional relevant MeSH terms:
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Liver Failure
Hepatic Insufficiency
End Stage Liver Disease
Acute-On-Chronic Liver Failure
Liver Diseases
Digestive System Diseases
Liver Failure, Acute