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临床试验/NCT05763446
NCT05763446招募中不适用

Predictive Factors for Massive Transfusion During Liver Transplantation: an Observational Study

Fondazione Policlinico Universitario Agostino Gemelli IRCCS2 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2021年7月31日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
400
试验地点
2
主要终点
Mortality

研究概览

简要总结

Liver transplantation (LT) is the treatment of choice for patients with end-stage liver disease (1). LT is often associated with severe intraoperative blood loss and the literature has had a great interest in clarifying the predictive factors for transfusion requirements during this surgery. Despite the advances in surgical techniques, graft preservation, and anesthetic management achieved over the past two decades, intraoperative bleeding and blood component consumption during LT are still issues of current interest. The requirement for blood components is highly variable between different transplant centers and ranges from none to many units of red blood cells (RBC), plasma, and platelets per patient. Bleeding associated with LT is multifactorial. Among the pre-transplantation factors, portal hypertension and coagulation defects are of great importance. The latter can develop or amplify during the anaepatic and/or neohepatic phase due to the absence of hepatic metabolic function, hyperfibrinolysis or platelet sequestration in the graft. In the literature, the higher transfusion requirement (HTR) is associated with worse postoperative outcomes, with an increase in both the length of stay in the intensive care unit (ICU) and in hospital, and mortality.

详细描述

The aim of this study is to evaluate the influence of increased transfusion requirements on the prognosis of patients undergoing LT and the risk factors for HTR. HTR is defined as the consumption of packed red blood cells (GRC) ≥ 5 units in the first 24 hours of surgery.

研究设计

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

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

  • Patients undergoing liver transplantation

排除标准

  • Age <18 years
  • Retransplantation within 30 days
  • Combined kidney-liver transplantation

结局指标

主要结局

Mortality

时间窗: 90 days

90-day postoperative mortality after liver transplantation

次要结局

  • In-hospital stay(Days until discharge from the hospital, an average of 14 days)
  • Post-transplant complication(90 days)
  • Postoperative mechanical ventilation(48 hours)
  • Intensive care unit stay(Days until discharge from ICU, an average of 5 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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