Is Redo Pediatric Cardiac Surgery a Risk Factor for Transfusion?

Completed

• Conditions: Pediatric Cardiac Surgery; Transfusion
• Interventions: Other: Redo op

• Registration Number: NCT04456751
• Lead Sponsor: Brugmann University Hospital

Brief Summary

In pediatric cardiac surgery, transfusion requirements are associated with age, development status, pathology, type of surgical intervention and extracorporeal bypass. In adult cardiac surgery, reinterventions (redo)are clearly linked to higher transfusion rates. The investigators want to study if this association is also true in pediatric cardiac surgery.

Detailed Description

Whereas in adult cardiac surgery, redo-interventions are clearly linked to a higher transfusion rate, this is not really known in paediatric cardiac surgery. In this retrospective study, the investigators will analyse our database for paediatric cardiac surgery patients aged 0-16 years and operated between 2002 and 2017. Patients with a single cardiac surgery will be compared to patients with a second cardiac operation under extracorporeal bypass. The investigators will test the variables for normal distribution using a Shapiro-Wilk test. Non normal distributed variables will be compared by a non-parametric test (Mann Whitney U), frequency analysis will be done by a Chi-Square test. A univariate analysis will determine predicting factors for transfusion. Factors with a P value \< 0.1 will be analysed by a multivariate analysis to determine independent factors for transfusion. Odds with 95% confidence intervals will be calculated. A P value \< 0.05 will be considered statistically significant.

Study Timeline

• Study First Submitted: 2020-06-25
• Study First Submitted QC: 2020-06-30
• Study Start: 2020-07-02
• Study First Posted: 2020-07-02
• Status Verified: 2020-08
• Primary Completion: 2020-08-15
• Study Completion: 2020-08-15
• Last Update Submitted: 2020-08-25
• Last Update Posted: 2020-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2439

Inclusion Criteria

• Patients between 0 and 16 years
• Cardiac surgery with cardiopulmonary bypass

Exclusion Criteria

• Jehova's witness

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Redo op	Redo op	Patients with a redo cardiac operation under extracorporeal bypass

Primary Outcome Measures

Name	Time	Method
Transfusion of packed red cells (mL/kg)	Day of operation up to 5 days postop	Transfusion requirements will be measured as volume of packed red cells given as mL packed red cells/kg of body weight

Trial Locations

Locations (1)

Hôpital Universitaire des Enfants Reine Fabiola; 🇧🇪 Brussels, Belgium