Is Redo Pediatric Cardiac Surgery a Risk Factor for Transfusion?

Is a Reintervention for Pediatric Cardiac Surgery Associated With Higher Blood Transfusion Requirements ?

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.

Study Overview

• Status: Completed
• Conditions: Pediatric Cardiac Surgery; Transfusion
• Intervention / Treatment: Other: Redo op

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 Type: Observational
• Enrollment (Actual): 2439

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1020
    • Hôpital Universitaire des Enfants Reine Fabiola

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 16 years (Child)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients between 0 and 16 years undergoing cardiac surgery with cardiopulmonary bypass in our institution. We will exclude Jehovah's witness patient as they refuse a transfusion.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Jehova's witness

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
No redo op; Patients with a single cardiac operation under extracorporeal bypass
Redo op; Patients with a redo cardiac operation under extracorporeal bypass	Other: Redo op; Patients with a redo operation

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Brugmann University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 2, 2020
• Primary Completion (Actual): August 15, 2020
• Study Completion (Actual): August 15, 2020

Study Registration Dates

• First Submitted: June 25, 2020
• First Submitted That Met QC Criteria: June 30, 2020
• First Posted (Actual): July 2, 2020

Study Record Updates

• Last Update Posted (Actual): August 26, 2020
• Last Update Submitted That Met QC Criteria: August 25, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: CHUB_redoped

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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