Evaluation of Pro-Inflammatory Leukocyte Activity in Patients Undergoing Cardiac Surgery

NCT04299828 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2026-01-07

No results posted yet for this study

Summary

The goal of this proposal is to prospectively collect data from a series of 200 patients (all ages) undergoing complex cardiac surgical procedures involving cardiopulmonary bypass (CPB) to:

1. Measure the number of blood activated circulating monocytes before, during and after cardiac surgery and serum GABA and pro-inflammatory cytokine levels
2. Understand the correlation between GABA and inflammatory cytokines (and/or activated monocytes) and
3. Assess the correlation between thrombosis and monocyte activation in patients undergoing cardiac surgery under CPB and at risk of thrombosis.

Conditions

  • Congenital Heart Disease
  • Coagulation

Interventions

OTHER

Discarded blood samples

Will utilize the discarded blood from routine clinical blood samples to evaluate the role of immune cells in coagulopathy.

Sponsors & Collaborators

Principal Investigators

  • Koichi Yuki, MD · Boston Children's Hospital

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-31
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04299828 on ClinicalTrials.gov