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临床试验/NCT00552357
NCT00552357招募中不适用

Clinical Risk Factors for Primary Graft Dysfunction

University of Pennsylvania1 个研究点 分布在 1 个国家目标入组 1,150 人开始时间: 2007年12月1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
1,150
试验地点
1
主要终点
Primary graft dysfunction, defined by the ISHLT criteria

研究概览

简要总结

Primary graft dysfunction (PGD) is a severe lung complication that can occur in the days after lung transplant surgery. This study will analyze blood samples to determine if high levels of certain chemicals may increase the risk of developing PGD after a lung transplant.

详细描述

PGD is a severe complication that affects up to 25% of lung transplant patients following surgery. Pulmonary edema, which is an abnormal build-up of fluid in the lungs, and hypoxemia, which is low blood oxygen levels, are two common symptoms that individuals with PGD experience. Treatment for PGD is often expensive, and it is the leading cause of death following lung transplantation. Many potential lung donors and recipients are considered unsuitable for lung transplantation because of concern for the development of PGD. Increased levels of chemicals that are involved in bleeding and clotting, including protein C, and certain markers of oxidant stress, which can cause damage to the body's cells and tissues, may increase a person's risk of developing complications following a lung transplant. The purpose of this study is to analyze blood samples to determine if elevated levels of certain chemicals may be associated with an increased risk of developing PGD after lung transplantation.

This study will enroll individuals who are undergoing lung or heart and lung transplantation. Blood samples will be collected from participants prior to surgery, immediately following surgery, and 24 hours after surgery. Study researchers will also review participants' medical records. There will be no additional study visits.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
13 Years 至 68 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Undergoing lung or combined heart and lung transplantation

排除标准

  • Undergoing combined organ transplantation other than heart and lung transplantation

结局指标

主要结局

Primary graft dysfunction, defined by the ISHLT criteria

时间窗: Measured within 72 hours following transplantation

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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