FFP Usage in Pediatric CV Surgery

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

Study Overview

• Status: Recruiting
• Conditions: Congenital Heart Disease; Coagulopathy

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 Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Mancho Ng, MD; Phone Number: 587-590-5690; Email: mancho@ualberta.ca

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2C8
      • Recruiting
      • University of Alberta
      • Contact: Mancho Ng, MD; Phone Number: 587-590-5690; Email: mancho@ualberta.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

pediatric patients between 4 and 8 kilograms with congenital cardiac defects

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
FFP; Patients undergoing CPB receiving FFP
no FFP; Patients undergoing CPB not receiving FFP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Transfusion	Units of blood products transfused	24 hours
Bleeding	Chest tube output	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of ventilation	Time to extubation	5 days
Length of stay	Time to ICU ready for discharge	5 days

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): August 28, 2023
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: April 6, 2023
• First Submitted That Met QC Criteria: April 6, 2023
• First Posted (Actual): April 19, 2023

Study Record Updates

• Last Update Posted (Actual): June 28, 2024
• Last Update Submitted That Met QC Criteria: June 27, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Diseases; Heart Defects, Congenital
• Other Study ID Numbers: Pro00129275

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No