Study on the Serum Metabolic Markers and Early Complications After Allogeneic Hematopoietic Stem Cell Transplantation in Hemaotological Diseases: Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 500
- 主要终点
- acute graft versus host disease
研究概览
简要总结
This study aims to establish a cohort of 500 patients with hematological disease who undergoing allogeneic hematopoietic stem cell transplantation in the northwest region. All patients will be followed up at the outpatient clinic once a week after transplantation until 100 days after transplantation to observe the presence of acute graft versus host disease, acute kidney damage, and major cardiovascular adverse events. Serum samples from the day before pre-treatment, day after pre-treatment, 2 weeks,4 weeks,8 weeks and 12 weeks after transplantation will be detected by metabolomics sequencing.The primary objective is to explore the serum metabolic markers of acute graft versus host disease,acute kidney injury, and major adverse cardiac events within 100 days after transplantation,the secondary objective is to observe the high-risk factors for early complications.
详细描述
This study aims to establish a cohort of 500 patients with hematological disease who undergoing allogeneic hematopoietic stem cell transplantation in the northwest region. All patients will be followed up at the outpatient clinic once a week after transplantation until 100 days after transplantation to observe the presence of acute graft versus host disease, acute kidney damage, and major cardiovascular adverse events. Baseline characterisitcs of patients, including gender, age, disease type, transplant type, donor gender and age, pre-transplant baseline electrocardiogram, myocardial enzymology, renal function, and other indicators were recorded. Serum samples from the day before pre-treatment, day after pre-treatment, 2 weeks,4 weeks,8 weeks and 12 weeks after transplantation will be detected by metabolomics sequencing.The primary objective is to explore the serum metabolic markers of acute graft versus host disease,acute kidney injury, and major adverse cardiac events within 100 days after transplantation,the secondary objective is to observe the high-risk factors for early complications.
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
- 0 Years 至 65 Years(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≤ 65 years old;
- •Gender unlimited;
- •Normal heart and kidney function before transplantation;
- •Patients with indications for allogeneic hematopoietic stem cell transplantation.
排除标准
- •CREA or BUN higher than the normal upper limit value before transplantation;
- •Individuals with a history of arrhythmia, heart failure, or PCI stent implantation prior to transplantation;
- •Patients with mental illness;
- •Those who are unwilling to sign informed consent.
结局指标
主要结局
acute graft versus host disease
时间窗: within 100 days after transplantation
skin,liver and gastrointestinal acute graft versus host disease
次要结局
- major adverse cardiac events(within 100 days after transplantation)
- acute kidney injury(within 100 days after transplantation)
