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临床试验/NCT04826666
NCT04826666已完成不适用

Intraoperative Phlebotomies and Bleeding in Liver Transplantation: a Retrospective Cohort Study and Causal Analysis Protocol

Centre hospitalier de l'Université de Montréal (CHUM)1 个研究点 分布在 1 个国家目标入组 679 人开始时间: 2021年3月31日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
679
试验地点
1
主要终点
Intraoperative bleeding

研究概览

简要总结

Liver transplantation are surgeries associated with important bleeding and often require perioperative red blood cell (RBC) transfusions. Overall, between 20 and 85 % of liver transplant recipients receive at least one RBC transfusion during their surgery. Such transfusions are consistently associated with higher morbidity and mortality, although this causal association is still under debate in many surgical populations. Despite the lack of clear causative association between perioperative transfusions and worse outcomes, minimizing bleeding and transfusions is believed to improve postoperative outcomes. Many perioperative variables are associated with higher blood loss and need for perioperative transfusions: liver disease severity, preoperative anemia and coagulopathy, higher cardiac filling pressures and higher fluid administration, among others. However, few perioperative interventions have been shown to reduce bleeding and transfusion requirements in this population. Among them, the use of intraoperative phlebotomies to reduce portal and hepatic venous pressure during the dissection phase is a promising one, also described in liver resection surgery.

To further investigate the effects of intraoperative phlebotomies on intraoperative bleeding, perioperative transfusions and mortality, the Principal Investigator will conduct a retrospective cohort study with a propensity score based causal analysis.

详细描述

Methods

Objective: To investigate the effects of intraoperative phlebotomies on intraoperative bleeding, perioperative transfusions and mortality among patients who underwent a liver transplantation.

Study design and participants:

All successive adult patients who underwent a liver transplantation between July 2008 and January 2021 at the Centre hospitalier de l'Université de Montréal (CHUM) will be included in the study. Because phlebotomies are mostly performed in patients with a near normal renal function, patients who were under renal replacement therapy prior to surgery as well as those who had a glomerular filtration rate below 30 mL/h (based on MDRD formula) will be excluded.

Exposure:

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • All successive adult patients who underwent a liver transplantation between July 2008 and January 2021 at the Centre hospitalier de l'Université de Montréal (CHUM).

排除标准

  • All patients who were under renal replacement therapy prior to surgery as well as those who had a glomerular filtration rate below 30 mL/h (based on MDRD formula).

结局指标

主要结局

Intraoperative bleeding

时间窗: During the liver transplantation

The intervention of interest is aimed at reducing bleeding. Even though intraoperative bleeding measurement is subject to measurement error, such measurement is homogeneously done through a cellsaver device at the CHUM..

次要结局

  • Any intraoperative red blood cell transfusions(During the liver transplantation)
  • Survival up to 1 year after liver transplantation(1 year after liver transplantation)
  • Perioperative red blood cell transfusions(Up to 48 hours after liver transplantation)

研究者

发起方
Centre hospitalier de l'Université de Montréal (CHUM)
申办方类型
Other
责任方
Sponsor

研究点 (1)

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