CompletedNot Applicable

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

China100 participantsStarted 2017-10-30

Plain-language 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.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

28-day mortality

Timeframe: 28-day

Trial details

NCT IDNCT03281278

SponsorNanfang Hospital, Southern Medical University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2018-08-13

View on ClinicalTrials.gov More Thrombelastography,Acute on Chronic Liver Failure, Platelet trials