Developing Novel Tools for Determining Risk of Respiratory Complications Following Hematopoietic Stem Cell Transplant
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 137
- 试验地点
- 1
- 主要终点
- Pulmonary complication following hematopoietic stem cell transplant (HCT)
研究概览
简要总结
This study evaluates whether clinical evaluation tools such as the six-minute walk test, hand grip strength test, and gait speed test, are useful in predicting risk of complications in patients undergoing hematopoietic stem cell transplants (HCT). Being able to predict who is at increased risk of post-HCT complications can help better inform patients and providers on the risks and benefits of undergoing HCT and determine whether certain patients should have closer post-HCT monitoring due to an increased risk of complications.
详细描述
PRIMARY OBJECTIVE:
I. To develop novel pre-transplant tools for determining risk of post-HCT pulmonary complications.
OUTLINE: This is an observational study.
Patients undergo a clinical evaluation consisting of a six-minute walk test, hand grip strength test, and gait speed test on study. Patients' medical records are also reviewed for a year on study.
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
- 否
入选标准
- •Adult patients (age >= 18 years old)
- •Undergoing evaluation for autologous or allogeneic bone marrow transplant (HCT) at Mayo Clinic Rochester
- •Scheduled for pre-HCT pulmonary function test by the primary team
排除标准
- •Limited mobility requiring use of gait aid or wheelchair
- •Fall risk
结局指标
主要结局
Pulmonary complication following hematopoietic stem cell transplant (HCT)
时间窗: Up to 1 year after transplant
Pulmonary complications may include but are not limited to: infection, HCT-specific lung injury syndromes, acute respiratory distress syndrome, pulmonary graft versus host disease. Univariable analysis will be first used to identify potential factors that predict post-HCT pulmonary complications. All possible factors will then be included in multivariable analysis. Will also specifically test whether the six-minute walk test, grip strength and gait speed add additional significance to pulmonary complications and the statistic model after including pulmonary function test results.
次要结局
- 100-day mortality(At 100 days after transplant)
- 1 year mortality(At 1 year after transplant)
- Hospital or intensive care unit admission post-HCT(Up to 1 year after transplant)
- Relapse-free survival(At 1 year after transplant)
- Need for noninvasive or invasive mechanical ventilation(Up to 1 year after transplant)