Clinical trial NCT04119973: A Multicenter Prospective Study of Application of Platelet Mapping in Acute-on-chronic-liver Failure in China
Official title: A Multicenter Prospective Study of Application of Platelet Mapping in Acute-on-chronic-liver Failure in China
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thrombelastography
Acute on Chronic Liver Failure
Platelet
Multicenter Prospective Study
Keywords: Thrombelastography
Acute on Chronic Liver Failure
Platelet
Multicenter Prospective Study
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
Collaborators: name: Southwest Hospital, China
name: The First Hospital of Jilin University
name: First Affiliated Hospital of Xinjiang Medical University
name: Meng Chao Hepatobiliary Hospital of Fujian Medical University
name: Xiangya Hospital of Central South University
name: Taihe Hospital
First posted: 2019-10-09
Enrollment: 486
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with ACLF regardless of aetiology, International Normalized Ratio (INR)≥1.5 and total bilirubin≥85μmol/L

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 28-day mortality
timeFrame: 28-day
Secondary outcomes:
measure: 28-day progression
timeFrame: 28-day
measure: 90-day mortality
timeFrame: 90-day
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Hepatology Unit, Department of Infectious Diseases, Nanfang Hospital, Southern Medical University
state: Guangdong
Study officials:
References: