Study on the Serum Metabolic Markers and Early Complications After Allo-HSCT： Cohort Study

Xi'an Jiaotong University

Status: Not yet enrolling

Conditions: Acute Graft Versus Host Disease; Acute Kidney Injury; Stem Cell Transplant Complications; Major Adverse Cardiac Events

Treatments: Other: Serum metabolomics sequencing

Study type: Observational

Funder types: Other

Identifiers

NCT06386445

XJTU1AF-CRF-2023-XK013

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: Under 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

500 participants in 1 patient group

XJTU Cohort of allo-HSCT

Description:

all the patients underwent allogeneic stem cell transplantation

Treatment:

Other: Serum metabolomics sequencing