Clinical trial NCT06386445: Study on the Serum Metabolic Markers and Early Complications After Allo-HSCT： Cohort Study
Official title: Study on the Serum Metabolic Markers and Early Complications After Allogeneic Hematopoietic Stem Cell Transplantation in Hemaotological Diseases： Cohort Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Stem Cell Transplant Complications
Acute Graft Versus Host Disease
Acute Kidney Injury
Major Adverse Cardiac Events
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2024-04-26
Enrollment: 500
Sex: ALL
Minimum age (years): 0
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with hematological disease underwent allogeneic stem cell transplantation

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.

Eligibility criteria: 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.

Primary outcomes:
measure: acute graft versus host disease
timeFrame: within 100 days after transplantation
Secondary outcomes:
measure: acute kidney injury
timeFrame: within 100 days after transplantation
measure: major adverse cardiac events
timeFrame: within 100 days after transplantation
Other outcomes:
Locations:
Study officials:
affiliation: First Affiliated Hospital Xi'an Jiaotong University
name: pengcheng he, M.D.
role: STUDY_DIRECTOR
References: