FFP Usage in Pediatric CV Surgery
- Conditions
- CoagulopathyCongenital Heart Disease
- Registration Number
- NCT05819788
- Lead Sponsor
- University of Alberta
- Brief Summary
When small children undergo heart surgery with the heart-lung machine, in the past, blood products to help the blood clot such as Fresh Frozen Plasma (FFP) was routinely used in children under 10kg. With blood clot monitoring technology, we feel that it might not be necessary to expose all children to FFP. We want to determine if those children who did not receive FFP bleed more or require more blood products as compared to those who did receive FFP while on the heart lung machine.
- Detailed Description
This will be a single center, retrospective study. Our cohort will include pediatric patients between 4 and 8 kilograms undergoing congenital cardiac surgery with cardiopulmonary bypass between January 2019 and January 2023. Patients will be divided into two groups: FFP given at onset of CPB and no FFP given intraoperatively. Patients requiring FFP for heparin resistance and anti-thrombin III deficiency will be excluded. Patient clinical, surgical, and bypass characteristics, transfusion, and bleeding outcomes will be collected using REDCAP and via chart review using Connect Care.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 500
- pediatric patients between 4 and 8 kilograms undergoing congenital cardiac surgery with cardiopulmonary bypass
- Patients requiring FFP for heparin resistance and anti-thrombin III deficiency will be excluded
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Transfusion 24 hours Units of blood products transfused
Bleeding 24 hours Chest tube output
- Secondary Outcome Measures
Name Time Method Length of stay 5 days Time to ICU ready for discharge
Length of ventilation 5 days Time to extubation
Trial Locations
- Locations (1)
University of Alberta
🇨🇦Edmonton, Alberta, Canada