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临床试验/NCT06212635
NCT06212635招募中不适用

Novel Biomarkers for Evaluation of Hemostasis and Inflammation in Liver Cirrhosis

Region Stockholm1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年12月2日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
1
主要终点
Correlation between systemic inflammation and hemostasis measured by novel assays

研究概览

简要总结

Evaluating hemostasis in decompensated liver cirrhosis with novel hemostatic assays.

详细描述

The rebalanced hemostasis in liver cirrhosis is vulnerable and patients are prone to both bleeding and thrombosis. There are today no gold standard for evaluating the hemostasis and we will evaluate novel methods for this.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with decompensated liver cirrhosis
  • 18 years or older.
  • Healthy individuals 18 years or older will serve as controls.

排除标准

  • • Extrahepatic malignancy or recurrence of such within the last year.
  • Diagnosis of non-cirrhotic coagulopathy, coagulation disorder or thrombophilia prior to inclusion.
  • Diagnosis of hematological disease such as hematologic malignancies, non-cirrhotic thrombocytopenia or thrombocytosis, Polycytemia Vera, hemoglobinopathies
  • Previous liver transplantation.
  • Transfusions the last 7 days.
  • Treatment with platelet inhibitors or anticoagulant except for prophylactic dosage of LMWH. If a prophylactic dose of LMWH has been used study sampling with addition of antiFXa must be taken >12 hours after the last injection.

结局指标

主要结局

Correlation between systemic inflammation and hemostasis measured by novel assays

时间窗: uo to 7 years

Correlation between systemic inflammation measured by cytokines, NETs and ECV and hemostasis measured by novel assays as in outcome 1

Differences in laboratory values between groupstests

时间窗: up to 5 years

Laboratory values of novel hemostasis tests TTAS, Quantra and OHP correlated to Rotem, TG and conventional coagulation assays. All tests have differnet values.

次要结局

  • Number of participant going to transplant(Up to 7 years)
  • Number of participant with bleeding(Up to 7 years)
  • Number of participants that die(Up to 7 years)
  • Number of participants with Thrombosis(Up to 7 years)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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