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OpenTrials
Completed

NCT Number: NCT04456751

Is Redo Pediatric Cardiac Surgery a Risk Factor for Transfusion?

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.

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Key information

Conditions

Pediatric Cardiac Surgery Transfusion

Age range

Up to 16 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Universitaire des Enfants Reine Fabiola

Brussels, 1020, Belgium

About this study

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.

Who can participate

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

Inclusion criteria

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

Exclusion criteria

  • Jehova's witness

Treatment and study plan

Redo op

Other

Patients with a redo operation

Primary outcomes

  1. Transfusion of packed red cells (mL/kg)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Brugmann University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jul 2, 2020
Registry last updated
Aug 26, 2020

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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