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临床试验/NCT03275077
NCT03275077已完成不适用

A Comparative Evaluation of Thromboelastogram and Conventional Coagulation Tests To Detect Coagulopathy in End Stage Renal Disease Patients

Institute of Liver and Biliary Sciences, India0 个研究点目标入组 100 人开始时间: 2016年3月12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
100
主要终点
To compare the maximum amplitude on a thromboelastography in patients of chronic kidney disease stage 5 with normal controls.

研究概览

简要总结

Background: Coagulopathy in chronic kidney disease is multifactorial. Both hypocoagulopathy and hypercoaguability are seen. Conventional tests of coagulation (CCTs) end at the formation of thrombin, and do not take into account the interaction of coagulation factors, platelets, RBC etc. By overcoming the above deficiencies, thromboelastography provides a holistic picture of blood coagulation. The present study evaluated the TEG profile of ESRD patients and compared it to CCTs and to controls.

Methods: 50 ESRD patients and 50 controls were recruited for the study. Venous samples were withdrawn and platelet count, INR and fibrinogen levels were measured. Simultaneously a Thromboelastography was performed. All samples were drawn prior to initiation of dialysis.

研究设计

研究类型
Observational
观察模型
Case Control
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

  • Healthy voluntary donors belonging to ASA PSI or ASA PSII
  • Patients suffering from end stage renal disease i.e. CKD stage 5 (Defined by KDIGO 2012 ) who never received renal replacement therapy (RRT)

排除标准

  • Patients on antiplatelet drugs, erythropoietin, desmopressin
  • Patients with known bleeding disorders like haemophilia, aplastic anaemia etc
  • Patients having coexisting liver diseases
  • Patients on dialysis
  • Patients who have received PRBC, FFPs or Platelet Transfusions in the past 3 months
  • Patients less than 18 years of age
  • Pregnant patients

结局指标

主要结局

To compare the maximum amplitude on a thromboelastography in patients of chronic kidney disease stage 5 with normal controls.

时间窗: 0 hr

Maximum amplitude in whole blood will be measures by a standard kaolin thromboelastography in all patients and controls.

次要结局

  • To correlate the maximum amplitude with platelet count and fibrinogen levels in patients of chronic kidney disease(0 hr)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

kelika Prakash

Asssitant Professor, Department of Anaesthesiology

Institute of Liver and Biliary Sciences, India

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