NCT04299828 · Boston Children's Hospital
Evaluation of Pro-Inflammatory Leukocyte Activity in Patients Undergoing Cardiac Surgery
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Boston, Massachusetts
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 7, 2026 · Source of record for eligibility and locations