Actively Recruiting
Mathematical Modeling of Salvaged Red Blood Cells-based Blood Management Strategy and Their Hemolytic Risk in Pediatric Cardiac Surgery
Led by Boston Children's Hospital · Updated on 2026-01-07
50
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying blood management in children under 18 years old who undergo heart surgery with cardio-pulmonary bypass. The study aims to understand the best amounts and types of blood products to use during these surgeries and to develop a mathematical model that could help predict and treat patients needing blood transfusions in this setting. The study is observational and involves collecting discarded blood samples taken from routine clinical labs during and after heart surgery at Boston Children's Hospital. These samples will be used to assess intraoperative hemolysis, which is the breakdown of red blood cells, using plasma free hemoglobin measurements during cardio-pulmonary bypass. Additionally, the study will examine hemolysis in vitro by co-incubating salvaged red blood cells with patients' plasma compared to their baseline red blood cells. Participants will be monitored during their heart surgery and routine lab work, with researchers analyzing blood samples collected during and after surgery. The main outcome measured is the level of hemolysis during surgery. This study does not involve experimental treatments but focuses on careful observation and modeling, with the overall goal of improving blood transfusion management for pediatric heart surgery patients. The study is expected to run until the end of 2026.
CONDITIONS
Brief Title
Modeling Blood Management and Hemolytic Risk in Pediatric Heart Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pediatric patients under 18 years of age undergoing cardiac surgery with clear prime on cardio-pulmonary bypass at Boston Children's Hospital
You will not qualify if you...
- Patients with known hemolytic disorders
- Patients on nitric oxide treatment before surgery
- Patients with abnormal blood clotting found on routine preoperative tests
- Patients receiving certain blood thinners (heparin, ASA, apixaban, warfarin, bivalirudin) appropriately held for elective surgery are not excluded
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day (during cardio-pulmonary bypass)
Participants undergo heart surgery with cardio-pulmonary bypass during which blood samples are collected from routine clinical labs for study assessments.
1 visit (in-person)
Duration - Up to several days post-surgery
Participants are observed post-surgery with additional blood samples collected from routine labs to assess hemolytic risk.
Additional routine clinical sample collections as part of hospital care
Trial Site Locations
Total: 1 location
1
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
Research Team
J
Jocelyn Booth, BSN
R
Rachel Bernier, MPH
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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