跳至主要内容
临床试验/NCT04111120
NCT04111120Unknown不适用

Assessment of Coagulation Profile and Role of Endogenous Heparinoids in SIRS and Sepsis in Acute Variceal Bleeding in Cirrhosis

Post Graduate Institute of Medical Education and Research, Chandigarh1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2019年11月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
75
试验地点
1
主要终点
Generation of Endogenous Heparinoids

研究概览

简要总结

This study attempts to clarify the pathophysiology of haemostasis in relation to the evidence of sepsis in liver disease, and compares the accuracy of various available laboratory tests in assessment of these patients. Further research is needed for proper understanding of the influence of sepsis on coagulation disorders in acute variceal bleeding in cirrhosis, to correctly identify the type and optimal quantity of blood product requirement in at risk patients.

Thromboelastography (TEG) /Sonoclot has been proposed as a superior tool to rapidly diagnose and help guide resuscitation with blood products. Secondly, the study of derangement in coagulopathy after the onset of sepsis is of paramount importance because of increased mortality after the onset of sepsis. In the present study, patients with cirrhosis who present with acute variceal bleeding, will be included in the study cohort, and will undergo a baseline diagnostic workup as described. They will be followed for development of any signs of infection after hospitalization. Then the effect of sepsis on their coagulation and thrombin generation response swill be assessed. Thus the effect of sepsis on the progression and outcome of coagulopathy in patients with acute variceal bleeding will be studied.

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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18-65 years
  • Cirrhosis with acute variceal bleeding.

排除标准

  • Patients with evidence of sepsis at presentation.
  • Current therapy: Recent blood or blood component transfusion in the last 2 weeks.
  • HIV positive/ AIDS patients
  • Patients requiring antiplatelet therapy,
  • Renal insufficiency requiring dialysis
  • Active malignancy within the last 5 years
  • Patient with other neurological disease and metabolic disorders, unbalanced heart failure and/or respiratory failure or end-stage renal disease
  • Administration of anticoagulants, antifibrinolytics,
  • Not willing to participate in the study

结局指标

主要结局

Generation of Endogenous Heparinoids

时间窗: 7 days

Change in SONOCLOT values- global and heparinase treated

Change in plasma levels of Specific Coagulation Factors -VIII, X, XIII, TPA and PAI

时间窗: 7 days

Specific factor assessment

次要结局

  • Correlation of sonoclot parameters- ACT, PF and Peak amplitude in predicting blood product utilization(7 Days)

研究者

发起方
Post Graduate Institute of Medical Education and Research, Chandigarh
申办方类型
Other
责任方
Principal Investigator
主要研究者

Madhumita Premkumar

Assistant Professor, Department of Hepatology

Post Graduate Institute of Medical Education and Research, Chandigarh

研究点 (1)

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