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Clinical Trials/NCT06214182
NCT06214182
Completed
Not Applicable

A Study of Immune Heterogeneity Before and After Cardiopulmonary Bypass in Children Undergoing Cardiac Surgery Based on ScRNA-seq

The Children's Hospital of Zhejiang University School of Medicine1 site in 1 country3 target enrollmentJanuary 1, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Ventricular Septal Defect
Sponsor
The Children's Hospital of Zhejiang University School of Medicine
Enrollment
3
Locations
1
Primary Endpoint
Expression of genes
Status
Completed
Last Updated
last year

Overview

Brief Summary

The goal of this observational study is to learn about functional heterogeneity of immune cells before and after cardiopulmonary bypass (CPB) in children with congenital heart disease (CHD). The main question[s] it aims to answer are:

  • Does CPB cause immune paralysis after CHD surgery?
  • How does the functional heterogeneity of immune cells change before and after CPB in children undergoing CHD surgery? Participants will receive 3ml of peripheral blood before CPB, 2 hours after CPB, and 3 days after CPB, and the peripheral blood samples will be sequenced by single cell to explore the immune heterogeneity before and after CPB.

Detailed Description

CPB-induced immune paralysis is the main cause of postoperative infection in CHD, which seriously affects the prognosis of children. The underlying mechanism of CPB-induced immune paralysis has not been fully determined. This study intends to use scRNA-seq to describe gene transcription profiles of immune cells in peripheral blood of children undergoing CHD surgery before and after CPB, and explore the differences within and between different immune cell populations including T cells and the changes of immune cells in different sequences. To fill the gap in the study of immune mechanism in CPB-induced immune paralysis microenvironment at single-cell resolution.

Registry
clinicaltrials.gov
Start Date
January 1, 2024
End Date
January 31, 2025
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
The Children's Hospital of Zhejiang University School of Medicine
Responsible Party
Principal Investigator
Principal Investigator

Wenyuan Zhang

Principal Investigator

The Children's Hospital of Zhejiang University School of Medicine

Eligibility Criteria

Inclusion Criteria

  • Birth weight range: 2500-6000g;
  • Operation duration \>90min;

Exclusion Criteria

  • preterm infants or preoperative infections;
  • systemic immune diseases and serious complications: such as rheumatoid arthritis, systemic lupus erythematosus, severe liver and kidney function damage, leukemia, etc.;
  • Patients who have received an organ transplant;
  • Patients who have received immunomodulatory drugs: patients who have received immunomodulatory drugs before surgery;
  • Parents refused to participate or were unable to provide sufficient samples: Parents or legal guardians refused to participate in the study.

Outcomes

Primary Outcomes

Expression of genes

Time Frame: From enrollment to the end of CPB at 3 days

The gene expression in single cells of peripheral blood samples was detected

Study Sites (1)

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