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OpenTrials
Completed

NCT Number: NCT05819788

FFP Usage in Pediatric CV Surgery

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.

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Key information

Conditions

Coagulopathy Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital Heart Disease Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Vascular Diseases

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Alberta

Edmonton, Alberta, T6G 2C8, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Transfusion

    Time frame: 24 hours

    Units of blood products transfused

  2. Bleeding

    Time frame: 24 hours

    Chest tube output

Secondary outcomes

  1. Length of ventilation

    Time frame: 5 days

    Time to extubation

  2. Length of stay

    Time frame: 5 days

    Time to ICU ready for discharge

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 19, 2023
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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