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临床试验/NCT06386445
NCT06386445尚未招募不适用

Study on the Serum Metabolic Markers and Early Complications After Allogeneic Hematopoietic Stem Cell Transplantation in Hemaotological Diseases: Cohort Study

First Affiliated Hospital Xi'an Jiaotong University0 个研究点目标入组 500 人开始时间: 2024年5月1日最近更新:
适应症

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

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)

研究者

申办方类型
Other
责任方
Sponsor

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