Predicting blood needs and hemolysis risk in children having heart surgery
Mathematical Modeling of Salvaged Red Blood Cells-based Blood Management Strategy and Their Hemolytic Risk in Pediatric Cardiac Surgery
Boston Children's Hospital · NCT06721455
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 |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 0 Years to 17 Years |
| Sex | All |
| Sponsor | Boston Children's Hospital (other) |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06721455 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Boston, Massachusetts
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Heart Surgery, Blood Transfusion, Hemolysis