Is Redo Pediatric Cardiac Surgery a Risk Factor for Transfusion?

Transfusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04456751
• Other study ID #: CHUB_redoped
• Status: Completed
• Start date: July 2, 2020
• Est. completion date: August 15, 2020

Study information

• Verified date: August 2020
• Source: Brugmann University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2439
• Est. completion date: August 15, 2020
• Est. primary completion date: August 15, 2020
• Gender: All
• Age group: N/A to 16 Years

Eligibility

Inclusion Criteria:

• Patients between 0 and 16 years

• Cardiac surgery with cardiopulmonary bypass

Exclusion Criteria:

• Jehova's witness

Related Conditions & MeSH terms

• Pediatric Cardiac Surgery
• Transfusion

Intervention

Other:
• Redo op
Patients with a redo operation

Locations

Country	Name	City	State
Belgium	Hôpital Universitaire des Enfants Reine Fabiola	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Brugmann University Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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