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

Study on the Serum Metabolic Markers and Early Complications After Allogeneic Hematopoietic Stem Cell Transplantation in Hemaotological Diseases： Cohort Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Graft Versus Host Disease; Acute Kidney Injury; Stem Cell Transplant Complications; Major Adverse Cardiac Events
• Intervention / Treatment: Other: Serum metabolomics sequencing

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.

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: xiaonig wang, M.D.; Phone Number: 02985323473; Email: wangxn99@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Patients with hematological disease underwent allogeneic stem cell transplantation

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
XJTU Cohort of allo-HSCT; all the patients underwent allogeneic stem cell transplantation	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
acute graft versus host disease	skin，liver and gastrointestinal acute graft versus host disease	within 100 days after transplantation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	within 100 days after transplantation
major adverse cardiac events	cardiovascular mortality, coronary events, heart failure, atrial fibrillation/flutter	within 100 days after transplantation

Collaborators and Investigators

• Sponsor: First Affiliated Hospital Xi'an Jiaotong University
• Investigators: Study Director: pengcheng he, M.D., First Affiliated Hospital Xi'an Jiaotong University

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: April 23, 2024
• First Submitted That Met QC Criteria: April 23, 2024
• First Posted (Actual): April 26, 2024

Study Record Updates

• Last Update Posted (Actual): April 26, 2024
• Last Update Submitted That Met QC Criteria: April 23, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Kidney Diseases; Urologic Diseases; Renal Insufficiency; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Cardiovascular Diseases; Acute Kidney Injury; Graft vs Host Disease
• Other Study ID Numbers: XJTU1AF-CRF-2023-XK013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No