An observational study in Coagulopathy and Congenital Heart Disease, sponsored by University of Alberta. Completed at 1 site in Canada. Open to participants aged Up to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by University of Alberta · Observational
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.
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.
3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.
This study's enrollment of 431 is above the median of 294 across 1,241 observational studies indexed under Heart Diseases.
Browse Heart Diseases studies →University of Alberta is the lead sponsor of 800 studies on the registry; 168 are open to participants now.
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pediatric patients between 4 and 8 kilograms with congenital cardiac defects
Exclusion Criteria:
Patients undergoing CPB receiving FFP
Patients undergoing CPB not receiving FFP
Transfusion
Units of blood products transfused
Time frame: 24 hours
Bleeding
Chest tube output
Time frame: 24 hours
Length of ventilation
Time to extubation
Time frame: 5 days
Length of stay
Time to ICU ready for discharge
Time frame: 5 days
This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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University of Alberta