NCT05819788

FFP Usage in Pediatric CV Surgery

Outcomes of Fresh Frozen Plasma Usage During Cardiopulmonary Bypass in Congenital Cardiac Surgery.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 431 (actual)
• Sponsor: University of Alberta · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Coagulopathy
• Congenital Heart Disease

Timeline

• Start date: 2023-08-28
• Primary completion: 2024-07-08
• Completion: 2024-07-08
• First posted: 2023-04-19
• Last updated: 2024-09-19

Locations

1 site across 1 country: Canada