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Observational Study on Immune Cells and Clotting After Heart Surgery

This observational study aims to understand why some people develop abnormal blood clots after heart surgery, especially when a heart-lung machine (cardiopulmonary bypass or CPB) is used. Researchers will look at discarded blood samples from routine tests to study how certain immune cells, called monocytes, might contribute to clotting. They will measure the activity of these monocytes, as well as levels of GABA and other inflammatory signals in your blood. The goal is to see if there's a link between these factors and the formation of clots. This study is for patients of all ages undergoing complex heart surgery with CPB. The study's success will be measured by understanding the role of monocyte activation and inflammatory markers in clotting. The current recruitment status is unclear.

Study design
This is an observational study planning to enroll 100 participants of all ages. It is not a randomized trial.
What's involved
You would provide discarded blood samples from routine clinical blood draws during and after your heart surgery. These samples will be used for experimental tests.
Compensation
Not stated in the trial record.
Follow-up
Your monocyte activation status and serum GABA and pro-inflammatory cytokines will be measured through study completion, on average one year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04299828

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

Recruiting
Not specifiedAll AgesObservational
Boston Children's Hospital
~100 participants
Updated 2026-01-07 on ClinicalTrials.gov
What's tested:Discarded blood samples

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Monocyte activation status
Measured over Through study completion; on average one year
+1 more outcome measured

Conditions

Congenital Heart Disease
Coagulation

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CoagulationCongenital Heart Disease

NCT04299828

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Boston Children's Hospital

    Boston, Massachusettsstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Koichi Yuki, MD · PRINCIPAL_INVESTIGATOR · Boston Children's Hospital

Who to contact

Koichi Yuki, MD
[email protected]
617-355-6225
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

Patients (all ages) undergoing complex cardiac surgical procedures with CPB.

Exclusion

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.

What this trial measures

  • Monocyte activation statusThrough study completion; on average one year

    characterization of monocyte activation status at baseline before surgery and throughout the course of CPB including post-operatively.

  • Serum GABA and pro-inflammatory cytokinesThrough study completion; on average one year

    Serum GABA and pro-inflammatory cytokines