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Is Redo Pediatric Cardiac Surgery a Risk Factor for Transfusion?

NCT ID: NCT04456751

Last Updated: 2020-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2439 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-02

Study Completion Date

2020-08-15

Brief Summary

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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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Detailed Description

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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.

Conditions

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Pediatric Cardiac Surgery Transfusion

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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No redo op

Patients with a single cardiac operation under extracorporeal bypass

No interventions assigned to this group

Redo op

Patients with a redo cardiac operation under extracorporeal bypass

Redo op

Intervention Type OTHER

Patients with a redo operation

Interventions

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Redo op

Patients with a redo operation

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Jehova's witness
Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Brugmann University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Denis SCHMARTZ

Head of Anesthesiology department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Denis Schmartz, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Brugmann

Locations

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Hôpital Universitaire des Enfants Reine Fabiola

Brussels, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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CHUB_redoped

Identifier Type: -

Identifier Source: org_study_id

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