Predicting blood needs and hemolysis risk in children having heart surgery
Official title: Mathematical Modeling of Salvaged Red Blood Cells-based Blood Management Strategy and Their Hemolytic Risk in Pediatric Cardiac Surgery
Run by Boston Children's Hospital · NCT06721455 · Data updated 2026-11-12
This project will collect blood samples from children having heart surgery to try to build a mathematical model that predicts transfusion needs and hemolysis risk during surgery.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 0 Years to 17 Years |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Boston Children's Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Status | Recruiting |
| Started | August 1, 2025 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | January 7, 2026 |
| Trial ID | NCT06721455 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children under 18 undergoing cardiac surgery with a clear prime on cardiopulmonary bypass at Boston Children's Hospital who do not have known hemolytic disorders or abnormal preoperative coagulation are ideal candidates.
✕Probably not a fit
Patients with known hemolytic disorders, those receiving preoperative nitric oxide, or those with abnormal routine coagulation are excluded and therefore may not receive benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational project will collect perioperative blood samples and clinical data from pediatric patients undergoing cardiac surgery with cardiopulmonary bypass at Boston Children's Hospital to measure hemolysis markers and transfusion parameters. Information on transfusion volumes, blood product types, and routine coagulation will be recorded alongside patient and operative variables. Researchers will combine these data to develop a mathematical model intended to predict which patients will need transfusions and who is at higher risk of hemolysis during surgery. The protocol excludes patients with known hemolytic disorders, those on preoperative nitric oxide, or those with abnormal routine preoperative coagulation.
Why it matters
Potential benefit: If successful, the model could help clinicians give the right amount and type of blood during pediatric heart surgery, potentially reducing transfusion-related complications.
How similar studies have gone: Previous research on transfusion practices and hemolysis in adults and some pediatric cohorts has provided useful data, but applying detailed intraoperative sampling combined with mathematical modeling in pediatric CPB is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * pediatric patients under 18 years of age undergoing cardiac surgery with clear prime on cardio-pulmonary bypass (CPB) at Boston Children's Hospital (BCH). Exclusion Criteria: * patients with known hemolytic disorders, patients on nitric oxide preoperatively, and patients found to have abnormal coagulation on routine preoperative assessment. Patients receiving heparin, American Society of Anesthesia (ASA) status, apixaban, warfarin, or bivalirudin held appropriately (i.e. for elective surgery) will not be excluded
Where it's running
-
Boston Children's Hospital
Boston, Massachusetts, United States Recruiting
Study contacts
- Principal investigator: Koichi Yuki, MD — Boston Children's Hospital
- Study coordinator: Jocelyn Booth, BSN
- Email: jocelyn.booth@childrens.harvard.edu
- Phone: 857-218-4585
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.