Plasma Proteomic Signatures of Pediatric Sepsis Reveal Persistent Inflammation and Phase-Specific Biomarkers.
Fahd Alhamdan, Yi-Cheng Sin, Erik Malm...
https://pubmed.ncbi.nlm.nih.gov/41815387Actively Recruiting
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ID04299828
Evaluation of Pro-Inflammatory Leukocyte Activity in Patients Undergoing Cardiac Surgery
Led by Boston Children's Hospital · Updated on 2026-01-07
100
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are studying patients of all ages undergoing complex heart surgeries that use cardiopulmonary bypass (CPB) to better understand blood clotting problems that can happen during and after surgery. The study focuses on the role of immune cells called monocytes and substances in the blood like GABA and inflammatory cytokines, which may contribute to abnormal clot formation and related complications. This observational research aims to explore these biological factors to improve future care for patients at risk of blood clots during heart surgery. The study uses discarded blood samples taken during routine clinical testing before, during, and after cardiac surgery to analyze monocyte activation and levels of serum GABA and pro-inflammatory cytokines. By collecting data over the course of surgery and recovery, the research team hopes to find links between immune activity and clotting risks. The study does not involve experimental treatments but focuses on detailed laboratory analyses of blood samples. Participants provide blood samples during their surgical care, with no additional interventions beyond routine clinical procedures. Researchers will monitor monocyte activation status and blood markers related to inflammation and clotting for about one year following surgery. The main outcomes measured include monocyte activation, serum GABA, pro-inflammatory cytokines, and clinical thrombosis events. This allows for a comprehensive assessment of factors involved in clotting complications after complex cardiac surgery with CPB.
CONDITIONS
Brief Title
Evaluation of Pro-Inflammatory Leukocyte Activity in Patients Undergoing Cardiac Surgery
Who Can Participate
All Genders
Eligibility Criteria
You may qualify if you...
- Patients of any age undergoing complex cardiac surgical procedures with cardiopulmonary bypass (CPB)
You will not qualify if you...
- Patients undergoing an emergency procedure with less than one hour to review consent
- Patients in moribund condition classified as American Society of Anesthesiology (ASA 5)
- Patients with hematological and/or oncological diseases
- Patients who are Jehovah's Witnesses
AI-Screening
AI-Powered Screening
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Surgery and Immediate Post-operative Care
Duration - Surgery day and immediate recovery period
Participants undergo complex cardiac surgery with cardiopulmonary bypass (CPB). Blood samples are collected during surgery and recovery using discarded routine clinical blood samples to study immune cell activity related to clotting.
Blood samples collected during surgery and recovery
Long-term Monitoring
Duration - Up to one year
Participants are monitored for up to one year after surgery to assess monocyte activation, serum markers, and clinical thrombosis.
Follow-up visits as per routine clinical care with blood sample analysis
Trial Site Locations
Total: 1 location
1
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
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Research Team
K
Koichi Yuki, MD
R
Rachel Bernier
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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