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临床试验/NCT04119973
NCT04119973已完成不适用

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

Nanfang Hospital, Southern Medical University1 个研究点 分布在 1 个国家目标入组 486 人开始时间: 2018年8月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
486
试验地点
1
主要终点
28-day mortality

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • INR≥1.5 and total bilirubin≥85μmol/L

排除标准

  • 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.

结局指标

主要结局

28-day mortality

时间窗: 28-day

death within 28-day

次要结局

  • 28-day progression(28-day)
  • 90-day mortality(90-day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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