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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04119973
Enrollment
486
Registered
2019-10-09
Start date
2018-08-16
Completion date
2019-11-04
Last updated
2020-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute on Chronic Liver Failure, Multicenter Prospective Study, Platelet, Thrombelastography

Keywords

Thrombelastography, Acute on Chronic Liver Failure, Platelet, Multicenter Prospective Study

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. 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.

Interventions

OTHERstandard treatment

standard medical treatment

Sponsors

Southwest Hospital, China
CollaboratorOTHER
The First Hospital of Jilin University
CollaboratorOTHER
First Affiliated Hospital of Xinjiang Medical University
CollaboratorOTHER
Meng Chao Hepatobiliary Hospital of Fujian Medical University
CollaboratorOTHER
Xiangya Hospital of Central South University
CollaboratorOTHER
Taihe Hospital
CollaboratorOTHER
Nanfang Hospital, Southern Medical University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
28-day mortality28-daydeath within 28-day

Secondary

MeasureTime frameDescription
28-day progression28-dayprogressed to EASL defined ACLF
90-day mortality90-daydeath within 90-day

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026