RecruitingNCT04299828

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


Sponsor

Boston Children's Hospital

Enrollment

100 participants

Start Date

May 31, 2022

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Plain Language Summary

Simplified for easier understanding

This study is measuring how the immune system — specifically white blood cells called leukocytes — becomes activated during complex heart surgery that uses a heart-lung bypass machine (cardiopulmonary bypass, or CPB). When blood flows through the bypass circuit, it can trigger inflammation, which may contribute to complications after surgery. Understanding exactly how this inflammation is triggered and progresses could lead to better ways to protect patients. Participants will have blood samples taken at multiple time points before, during, and after surgery. The study is observational — researchers will not change how the surgery is performed or prescribe any additional treatments. You may be eligible if you: - Are a patient of any age scheduled for a complex cardiac surgical procedure using cardiopulmonary bypass (CPB) You may NOT be eligible if you: - Are undergoing an emergency procedure with less than 1 hour available to review and sign the consent - Are in a critically ill (moribund) condition — ASA classification 5 - Have a hematological or oncological (blood or cancer) disease - Are a Jehovah's Witness (due to potential blood handling requirements) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERDiscarded blood samples

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


Locations(1)

Boston Children's Hospital

Boston, Massachusetts, United States

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NCT04299828


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