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FFP Usage in Pediatric CV Surgery

Sponsor
University of Alberta (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05819788
Collaborator
(none)
500
Enrollment
7
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    500 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Outcomes of Fresh Frozen Plasma Usage During Cardiopulmonary Bypass in Congenital Cardiac Surgery.
    Anticipated Study Start Date :
    May 1, 2023
    Anticipated Primary Completion Date :
    Sep 1, 2023
    Anticipated Study Completion Date :
    Dec 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    FFP

    Patients undergoing CPB receiving FFP
    no FFP

    Patients undergoing CPB not receiving FFP

    Outcome Measures

    Primary Outcome Measures

    1. Transfusion [24 hours]

      Units of blood products transfused

    2. Bleeding [24 hours]

      Chest tube output

    Secondary Outcome Measures

    1. Length of ventilation [5 days]

      Time to extubation

    2. Length of stay [5 days]

      Time to ICU ready for discharge

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University of Alberta

    Investigators

    • Principal Investigator: Mancho Ng, MD, University of Alberta

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Alberta
    ClinicalTrials.gov Identifier:
    NCT05819788
    Other Study ID Numbers:
    • Pro00129275
    First Posted:
    Apr 19, 2023
    Last Update Posted:
    Apr 19, 2023
    Last Verified:
    Apr 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Heart Diseases
    Heart Defects, Congenital

    Study Results

    No Results Posted as of Apr 19, 2023