- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03281278
A Prospective Study of Application of Platelet Mapping in HBV-related Acute-on-chronic-liver Failure in China
June 4, 2019 updated by: Nanfang Hospital of Southern Medical University
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510515
- Nanfang Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
28-day mortality
Time Frame: 28-day
|
death within 28-day
|
28-day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
28-day progression
Time Frame: 28-day
|
progressed to EASL defined ACLF
|
28-day
|
90-day mortality
Time Frame: 90-day
|
death within 90-day
|
90-day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 30, 2017
Primary Completion (Actual)
August 13, 2018
Study Completion (Actual)
August 13, 2018
Study Registration Dates
First Submitted
September 11, 2017
First Submitted That Met QC Criteria
September 11, 2017
First Posted (Actual)
September 13, 2017
Study Record Updates
Last Update Posted (Actual)
June 6, 2019
Last Update Submitted That Met QC Criteria
June 4, 2019
Last Verified
April 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 003 (NuSkin International)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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