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临床试验/NCT00837681
NCT00837681已完成不适用

Pulmonary Complications of Hematopoietic Stem Cell Transplantation

Karen Wood1 个研究点 分布在 1 个国家目标入组 350 人开始时间: 2005年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
350
试验地点
1
主要终点
To determine factors contributing to the development of lung disease after hematopoietic stem cell transplantation (HSCT

研究概览

简要总结

The purpose of this study is to determine risk factors associated with the development of lung disease after hematopoietic stem cell transplantation. Depending on the results and findings of this study, it may be possible to predict who is at higher risk of serious complications and ultimately develop therapies to prevent or treat this lung disease.

详细描述

The development of pulmonary complications after hematopoietic stem cell transplantation is responsible for significant morbidity and mortality. The incidence of pulmonary disease has been reported to be as high as 50% of all patients that undergo transplant. The most common manifestation of early onset lung disease is idiopathic pneumonia syndrome. This can occur in autologous and allogeneic transplants, with an incidence between 5% and 10% and a mortality rate as high as 74%(1). Late onset pulmonary disease may be even more frequent and has been reported between 10-24% in recipients of allogeneic HSCT(2-4). Additionally, a recent study demonstrated 26% of patients develop airflow obstruction after transplant and this was correlated with mortality(5). One quite useful classification system divides late onset pulmonary disease into bronchiolitis obliterans and interstitial pneumonia(4). Interstitial pneumonia is a condition characterized by diffuse infiltrates, often with lymphocyte predominance, and associated with restrictive defects on pulmonary function testing. Bronchiolitis obliterans is characterized by progressive airflow obstruction and a normal radiograph (except possibly associated air trapping). The incidence of bronchiolitis obliterans after HSCT varies widely, but is usually reported to be between 1% and 11%(6-8), although the presence of post HSCT obstructive airway disease was reported at 26% in a recent large study(5). Late onset pulmonary diseases are often treated with increased immunosuppression, but the prognosis is poor with limited response to therapy(9; 4).

研究设计

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

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

  • All patients scheduled to undergo hematopoietic stem cell transplantation (HSCT)

排除标准

  • Patients whose ability to give informed consent is in question.

结局指标

主要结局

To determine factors contributing to the development of lung disease after hematopoietic stem cell transplantation (HSCT

时间窗: end of study

次要结局

  • 1b) To identify the mechanisms by which CD8+ regulatory cells suppress the alloimmune response.(end of study)

研究者

发起方
Karen Wood
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Karen Wood

Karen Wood M.D.

Ohio State University

研究点 (1)

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