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NCT05819788 Clinical Trial

FFP Usage in Pediatric CV Surgery

Congenital Heart Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05819788
Other study ID # Pro00129275
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 28, 2023
Est. completion date May 2024

Study information
Verified date January 2024
Source University of Alberta
Contact Mancho Ng, MD
Phone 587-590-5690
Email mancho@ualberta.ca
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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 information / eligibility
Status Recruiting
Enrollment 500
Est. completion date May 2024
Est. primary completion date May 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 18 Years
Eligibility Inclusion Criteria: - pediatric patients between 4 and 8 kilograms undergoing congenital cardiac surgery with cardiopulmonary bypass Exclusion Criteria: - Patients requiring FFP for heparin resistance and anti-thrombin III deficiency will be excluded

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Canada University of Alberta Edmonton Alberta

Sponsors (1)
Lead Sponsor Collaborator
University of Alberta

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Transfusion Units of blood products transfused 24 hours
Primary Bleeding Chest tube output 24 hours
Secondary Length of ventilation Time to extubation 5 days
Secondary Length of stay Time to ICU ready for discharge 5 days
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