Evaluating immune cell activity in patients undergoing heart surgery
Official title: Evaluation of Pro-Inflammatory Leukocyte Activity in Patients Undergoing Cardiac Surgery
Run by Boston Children's Hospital · NCT04299828 · Data updated 2026-11-12
This study is trying to see how immune cell activity during heart surgery affects the risk of blood clots in patients.
Quick facts
| Study type | Observational |
|---|---|
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Boston Children's Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Status | Recruiting |
| Started | May 31, 2022 |
| Main results expected | December 2026 |
| Study ends | December 2026 |
| Registry record updated | January 7, 2026 |
| Trial ID | NCT04299828 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include patients of all ages scheduled for complex cardiac surgical procedures with cardiopulmonary bypass.
✕Probably not a fit
Patients undergoing emergent procedures or those in a moribund condition may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to collect data from 100 patients of all ages undergoing complex cardiac surgeries involving cardiopulmonary bypass (CPB). It will measure activated circulating monocytes and levels of serum GABA and pro-inflammatory cytokines before, during, and after surgery. The study seeks to understand the correlation between these immune responses and the risk of thrombosis, which can lead to complications post-surgery. By analyzing blood samples at various stages, the researchers hope to uncover the role of immune cells in abnormal clot formation during cardiac procedures.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and prevention of abnormal blood clotting in patients undergoing heart surgery.
How similar studies have gone: While the specific approach of this study is novel, similar studies have explored the role of immune cells in coagulation with varying degrees of success.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients (all ages) undergoing complex cardiac surgical procedures with CPB. Exclusion Criteria: * undergoing an emergent procedure and do not have more than 1 hour ahead of time to review the consent * patient in a moribund condition American Society of Anesthesiology (ASA 5) -patient with a hematological and/or oncological disease * Jehovah witnesses.
Where it's running
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Boston Children's Hospital
Boston, Massachusetts, United States Recruiting
Study contacts
- Principal investigator: Koichi Yuki, MD — Boston Children's Hospital
- Study coordinator: Koichi Yuki, MD
- Email: koichi.yuki@childrens.harvard.edu
- Phone: 617-355-6225
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.