跳至主要内容
临床试验/NCT03756948
NCT03756948已完成不适用

Association Between Viscoelastic Tests-Guided Therapy With Synthetic Factor Concentrates And Allogenic Blood Transfusion In Liver Transplantation: A Before-After Study

Hospital Israelita Albert Einstein0 个研究点目标入组 237 人开始时间: 2007年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
237
主要终点
Need of Any Blood Products Transfusion

研究概览

简要总结

BACKGROUND: Perioperative bleeding and transfusion are important causes of morbidity and mortality in patients undergoing liver transplantation. The aim of this study is to assess whether viscoelastic tests-guided therapy with the use of synthetic factor concentrates impact transfusion rates of hemocomponents in adult patients undergoing liver transplantation.

METHODS: This is an interventional before-after comparative study. Patients undergoing liver transplantation before the implementation of a protocol using thromboelastometry and synthetic factor concentrates were compared to patients after the implementation. Primary outcome was transfusion of any hemocomponents. Secondary outcomes included: transfusion of red blood cells (RBC), fresh frozen plasma (FFP), cryoprecipitate or platelets, clinical complications, length of stay and in-hospital mortality.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
主要目的
Treatment
盲法
None

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

  • Deceased Donor Liver Transplantation
  • Chronic Liver Disease

排除标准

  • Acute Liver Failure
  • Combined Transplantation
  • Re-Transplantation is Less Than 30 Days After the First Transplant

研究组 & 干预措施

Usual Care (Before)

Active Comparator

No Thromboelastometry No Synthetic Factor Concentrates Usual Care

干预措施: Usual Care (Other)

Thromboelastometry-Guided Therapy (After)

Experimental

Thromboelastometry-Guided Therapy with Synthetic Factor Concentrates

干预措施: Thromboelastometry-Guided Therapy with Synthetic Factor Concentrates (Other)

结局指标

主要结局

Need of Any Blood Products Transfusion

时间窗: 48 Hours

Collapsed composite of need of any transfusion of blood product during surgery and in the first 48 hours in the postoperative, including the need of RBC, FFP, cryoprecipitate and/or platelets.

次要结局

  • Duration of Mechanical Ventilation(Third days or until hospital discharge, whichever occurs first)
  • ICU Length of Stay(Third days or until ICU discharge, whichever occurs first)
  • Hospital Length of Stay(Third days or until hospital discharge, whichever occurs first)
  • Use of Synthetic Factor Concentrates or Antifibrinolytic(48 Hours)
  • Clinical Complications Related to the Procedure(Third days or until hospital discharge, whichever occurs first)
  • In-Hospital Mortality(Third days or until hospital discharge, whichever occurs first)

研究者

申办方类型
Other
责任方
Sponsor

相似试验