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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0-65
SponsorFirst Affiliated Hospital Xi'an Jiaotong University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≤ 65 years old;

Disqualifiers

CREA or BUN higher than the normal upper limit value before transplantation;

Trial population

Patients with hematological disease underwent allogeneic stem cell transplantation

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Serum metabolomics sequencing

    Other intervention

    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.

Treatment groups

500 Participants
are divided into 1 treatment group
Group A: XJTU Cohort of allo-HSCT1 intervention

Trial outcomes

Primary outcomes

1

acute graft versus host disease

skin,liver and gastrointestinal acute graft versus host disease

Time frame
within 100 days after transplantation

Secondary outcomes

1

acute kidney injury

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.

Time frame
within 100 days after transplantation
2

major adverse cardiac events

cardiovascular mortality, coronary events, heart failure, atrial fibrillation/flutter

Time frame
within 100 days after transplantation

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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