NCT04299828 Evaluation of Pro-Inflammatory Leukocyte Activity in Patients Undergoing Cardiac Surgery
| NCT ID | NCT04299828 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Boston Children's Hospital |
| Condition | Congenital Heart Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2022-05-31 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2022-05-31 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Koichi Yuki, MD
PRINCIPAL INVESTIGATOR
Boston Children's Hospital
Frequently Asked Questions
Who can join the NCT04299828 clinical trial?
This trial is open to participants of all sexes, studying Congenital Heart Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04299828 currently recruiting?
Yes, NCT04299828 is actively recruiting participants. Contact the research team at koichi.yuki@childrens.harvard.edu for enrollment information.
Where is the NCT04299828 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT04299828 clinical trial?
NCT04299828 is sponsored by Boston Children's Hospital. The principal investigator is Koichi Yuki, MD at Boston Children's Hospital. The trial plans to enroll 100 participants.