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临床试验/NCT05333510
NCT05333510已完成不适用

A Comparative Evaluation of Thromboelastography Versus Thromboelastometry for Coagulopathy Correction in Patients of Liver Cirrhosis With Non Variceal Bleed- Prospective Observational Study

Institute of Liver and Biliary Sciences, India1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年7月1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
60
试验地点
1
主要终点
Total amount of blood products transfused at 8 hours(FFP, Cryoprecipitate, platelets) will be measured

研究概览

简要总结

Studies comparing Thromboelastography or Rotational thromboelastometry versus standard coagulation tests are abundant. Data comparing the two exclusively in a liver intensive care set up is limited.

Studies show that TEG and ROTEM cannot be used interchangeably in trauma, liver transplant patients, but there is limited evidence of the same in critically ill cirrhotic patients.

In this study, the investigators tried to demonstrate the comparison of blood products used to treat coagulopathy based on TEG versus ROTEM algorithms in cirrhotic patients presenting with non variceal bleeding

详细描述

Thromboelastography (TEG) and thromboelastometry( ROTEM) are point-of-care, global hemostasis assessment tests that measure the viscoelastic changes that occur during the hemostatic process.

Patients with cirrhosis have an imbalance of procoagulants and anticoagulants combined with alterations in fibrinolysis ,platelet number and function.

Point of care viscoelastic tests (TEG ,ROTEM) demonstrate specific functional coagulation defects that can direct blood component transfusion therapy in cirrhosis, with clinical validation of individual parameters.

Studies comparing Thromboelastography or Rotational thromboelastometry versus standard coagulation tests are abundant. Data comparing the two exclusively in a liver intensive care set up is limited.

Studies show that TEG and ROTEM cannot be used interchangeably in trauma, liver transplant patients, but there is limited evidence of the same in critically ill cirrhotic patients.

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

入选标准

  • patients of liver cirrhosis with non variceal bleed

排除标准

  • Pregnant and postpartum patients
  • died within the first 24hours of admission.
  • variceal and postvariceal ligation ulcer bleed.
  • On anticoagulants or antiplatelets at the time of admission in ICU
  • Transfusion with blood products before admission to the ICU.

结局指标

主要结局

Total amount of blood products transfused at 8 hours(FFP, Cryoprecipitate, platelets) will be measured

时间窗: 8 hours

Total amount of blood products transfused at 8 hours(FFP, Cryoprecipitate, platelets) will be measured

次要结局

  • LY30 Iin thromboelastometry(8 hours)
  • LI30 in thromboelastometry(8 hours)
  • Control of bleeding at 48 hours(48 hours)
  • Maximum amplitude of thromboleastography(8 hours)
  • K time of thromboelastography(8 hours)
  • alpha angle of thromboelastography(8 hours)
  • Clot formation time in thromboelastometry(8 hours)
  • Maximum clot firmness in thromboelastometry(8 hours)
  • R time of thromboelastography(8 hours)
  • Clotting time in thromboelastometry(8 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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