- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04119973
A Multicenter Prospective Study of Application of Platelet Mapping in Acute-on-chronic-liver Failure in China
January 6, 2020 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.
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
486
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
- Hepatology Unit, Department of Infectious Diseases, Nanfang Hospital, Southern Medical University
-
-
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 ACLF regardless of aetiology, International Normalized Ratio (INR)≥1.5 and total bilirubin≥85μmol/L
Description
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.
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
- Observational Models: Cohort
- Time Perspectives: Prospective
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)
August 16, 2018
Primary Completion (Actual)
August 4, 2019
Study Completion (Actual)
November 4, 2019
Study Registration Dates
First Submitted
October 7, 2019
First Submitted That Met QC Criteria
October 7, 2019
First Posted (Actual)
October 9, 2019
Study Record Updates
Last Update Posted (Actual)
January 9, 2020
Last Update Submitted That Met QC Criteria
January 6, 2020
Last Verified
May 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 009
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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