Modeling Blood Management and Hemolytic Risk in Pediatric Heart Surgery
Not yet recruiting
- Conditions
- Heart SurgeryBlood TransfusionHemolysis
- Registration Number
- NCT06721455
- Lead Sponsor
- Boston Children's Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 50
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Intraoperative hemolysis during pediatric cardiac cardio-pulmonary bypass (CPB) cases as assessed using the plasma free hemoglobin assessment 1 day (during cardio-pulmonary bypass)
- Secondary Outcome Measures
Name Time Method In vitro salvaged red blood cells (RBCs) co-incubation with patients' plasma for hemolysis assessment compared to patients' baseline RBCs 1 day
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
How do salvaged red blood cells contribute to hemolytic pathways in pediatric cardiac surgery?
What is the comparative effectiveness of mathematical modeling vs standard blood management in reducing transfusions during pediatric heart surgery?
Which biomarkers predict hemolytic risk in pediatric patients using salvaged RBCs during cardiac surgery?
What adverse events are associated with salvaged RBC transfusion in pediatric heart surgery and how are they managed?
How does the NCT06721455 model compare to normovolemic hemodilution or pharmacological blood conservation strategies in pediatric cardiac surgery?
Trial Locations
- Locations (1)
Boston Children's Hospital
🇺🇸Boston, Massachusetts, United States