A Cohort Study on the Association Between the Autonomic Nervous System Function and Acute GvHD After Patients Receiving Allogeneic Hematopoietic Stem Cell Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Result of heart rate response to standing test
研究概览
简要总结
This is a prospective observational study. The investigators plan to utilize this model as a tool for early classification and interrogate ANS function of transplant recipients.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must be > 16 years of age;
- •Patients receiving HLA-haploidentical transplants;
- •Patients have to sign an informed consent form before the start of the research procedure.
排除标准
- •Tandem transplantation or multiple transplantations;
- •Mental or other medical conditions that make the patients unable to comply with the research treatment and monitoring requirements;
- •Patients who are ineligible for the study due to other factors, or will bear great risk if participating in the study.
研究组 & 干预措施
Adult patients receiving HLA-haploidentical transplants
结局指标
主要结局
Result of heart rate response to standing test
时间窗: Within one month before the transplantation and during 17-25 days after the transplantation.
Autonomic nervous system functional tests including heart rate response to standing will be performed within one month before the transplantation and during 17-25 days after the transplantation.
Result of piloerection test
时间窗: Within one month before the transplantation and during 17-25 days after the transplantation.
Autonomic nervous system functional tests including piloerection will be performed within one month before the transplantation and during 17-25 days after the transplantation.
Number of participants with abnormal dynamic electrocardiography readings
时间窗: Within one month before the transplantation and during 17-25 days after the transplantation.
Dynamic electrocardiography will be performed within one month before the transplantation and during 17-25 days after the transplantation.
次要结局
- Incidence of severe acute GvHD after transplantation within 100 days and incidences of acute GvHD (any grade) in various target organs.(100 days after transplantation)