Study on the Serum Metabolic Markers and Early Complications After Allo-HSCT： Cohort Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Serum metabolomics sequencing.
- Who it may be relevant to
- Registry conditions: Stem Cell Transplant Complications, Acute Graft Versus Host Disease, Acute Kidney Injury, Major Adverse Cardiac Events. Basic parameters: 0 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Study on the Serum Metabolic Markers and Early Complications After Allogeneic Hematopoietic Stem Cell Transplantation in Hemaotological Diseases： Cohort Study
Overview
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
- Other Serum 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.
Primary outcome measures
- acute graft versus host disease [Time frame: within 100 days after transplantation]
Secondary outcome measures (2)
- acute kidney injury [Time frame: within 100 days after transplantation]
- major adverse cardiac events [Time frame: within 100 days after transplantation]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06386445 · XJTU1AF-CRF-2023-XK013