NCT06721455 Modeling Blood Management and Hemolytic Risk in Pediatric Heart Surgery
| NCT ID | NCT06721455 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Boston Children's Hospital |
| Condition | Heart Surgery |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-08-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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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 50 participants in total. It began in 2025-08-01 with a primary completion date of 2026-12-31.
⚠ 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
This study aims to learn more about blood management in children undergoing heart surgery, such as the right amounts, and the best blood products, to administer. It also aims to develop a mathematical model that may help researchers better predict and treat patients who need blood transfusions during heart surgery.
Eligibility 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
Contact & Investigator
Koichi Yuki, MD
PRINCIPAL INVESTIGATOR
Boston Children's Hospital
Frequently Asked Questions
Who can join the NCT06721455 clinical trial?
This trial is open to participants of all sexes, aged 0 Years or older, up to 17 Years, studying Heart Surgery. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06721455 currently recruiting?
Yes, NCT06721455 is actively recruiting participants. Contact the research team at jocelyn.booth@childrens.harvard.edu for enrollment information.
Where is the NCT06721455 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT06721455 clinical trial?
NCT06721455 is sponsored by Boston Children's Hospital. The principal investigator is Koichi Yuki, MD at Boston Children's Hospital. The trial plans to enroll 50 participants.