Acute Graft Versus Host Disease, Acute Kidney Injury, Major Adverse Cardiac Events, Stem Cell Transplant Complications
Conditions
Brief summary
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.
Detailed description
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.
Interventions
OTHERSerum metabolomics sequencing
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.
Sponsors
First Affiliated Hospital Xi'an Jiaotong University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
0 Years to 65 Years
Inclusion criteria
* Age ≤ 65 years old; Gender unlimited; Normal heart and kidney function before transplantation; Patients with indications for allogeneic hematopoietic stem cell transplantation.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| acute graft versus host disease | within 100 days after transplantation | skin，liver and gastrointestinal acute graft versus host disease |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| acute kidney injury | within 100 days after transplantation | Included AKI-R, AKI-I, and AKI-F ，the criteria for classification of AKI-R, AKI-I, and AKI-F are as follows: AKI-R was considered if there was an increase in serum creatinine to more than 1.5-fold of baseline value or a urinary output lower than 0.5 ml/kg/h for 6 h. AKI-I was considered if there was an increase in serum creatinine to more than 2-fold of baseline value or urinary output lower than 0.5 ml/kg/h for 12 h. AKI-F was considered if there was an increase in serum creatinine to more than 3-fold baseline value or urinary output lower than 0.3 ml/kg/h for 24 h. |
| major adverse cardiac events | within 100 days after transplantation | cardiovascular mortality, coronary events, heart failure, atrial fibrillation/flutter |
Contacts
Primary Contactxiaonig wang, M.D.
Outcome results
None listed