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临床试验/NCT02597218
NCT02597218Unknown不适用

Incidence of Venous Thromboembolic Disease and Portal Vein Thrombosis After Hepatectomy in a High-volume Center. A Cohort Study.

Hospital Italiano de Buenos Aires1 个研究点 分布在 1 个国家目标入组 350 人开始时间: 2015年10月最近更新:
适应症

试验速览

阶段
不适用
入组人数
350
试验地点
1
主要终点
Venous thromboembolism (VTE)

研究概览

简要总结

Observational. Retrospective cohort.

详细描述

Venous thromboembolism (VTE) is a disease that includes both deep vein thrombosis (DVT) and pulmonary embolism (PE). It is a common, potentially lethal disorder that can occur among postoperative patients. Liver surgery implies a prothrombotic state, as a result of an alteration of the equilibrium between synthesis and use of pro and anti coagulant factors after a parenquimal resection. The use of antithrombotic prophylaxis following surgery is not standarized, and current practices vary depending on the attendant surgeon's particular experience or hospital's customs and habits.

In published research, postoperative patients have been studied as a whole so far. There is little evidence regarding patients undergoing hepatectomy. Furthermore, the use and need of extended prophylaxis remains unexplored in this group of patients.

The objetives of the following study are:

  • To estimate the incidence of symptomatic venous thromboembolism (VTE) [deep vein thrombosis (DVT), pulmonary embolism (PE) and fatal PE] in a third level center in patients undergoing any hepatectomy within 90 days after surgery.
  • To estimate the incidence of portal thrombosis (PT) in a third level center in patients undergoing any hepatectomy within 90 days after surgery.
  • To identify and describe factors associated to the development of VTE in patients following hepatectomy.
  • To identify and describe factors associated to the development of PT in patients following hepatectomy.
  • To describe major bleedings or minor but clinically relevant bleedings during the period in which those patients received chemical thromboprophylaxis.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

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

  • Older than 18 years old.
  • Following hepatic surgery.

排除标准

  • Living donor
  • Venous thromboembolism within 6 months previous to surgery.

结局指标

主要结局

Venous thromboembolism (VTE)

时间窗: 90 days following surgery

Includes deep vein thrombosis (DVT) and pulmonary embolism (PE)

次要结局

  • Minor bleeding(90 days following surgery)
  • Major bleeding(90 days following surgery)
  • Portal Thrombosis (PT)(90 days following surgery)

研究者

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

Diego Hernan Giunta, MD

MD

Hospital Italiano de Buenos Aires

研究点 (1)

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