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Study on the Transfusional Management of the Patients With Congenital Heart Disease Carried Out in Adulthood.

Observational Retrospective Study on the Transfusional Management of the Patients With Congenital Heart Disease Carried Out in Adulthood.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03063801
Enrollment
300
Registered
2017-02-24
Start date
2017-04-01
Completion date
2017-06-01
Last updated
2017-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital Heart Defect

Keywords

Congenital Heart Disease, Blood products transfusion

Brief summary

Surgeries of heart disease in adulthood can happen in two specific contexts: * either for an asymptomatic anomaly, possibly coupled with the onset of symptoms later in life and tardily diagnosed and surgically managed * either for a malformation treated in childhood and requiring a new intervention in adulthood. In recent years, the number of adult patients with congenital heart disease has been steadily increasing. Advances in diagnostic techniques and surgical treatments have enabled many children to reach adulthood. The number of these patients is now higher than the number of children with congenital heart disease. The number of these patients having had surgery in adulthood is also increasing. Congenital cardiopathies are numerous, ranging from simpler pathologies such as inter-auricular or inter-ventricular communication, to much more complex pathologies such as situations of univentricular hearts. The surgical treatments of these congenital heart diseases are classified into three groups: initial palliative surgery, initial curative surgery or iterative surgery. Palliative surgery aims to improve the clinical tolerance of the patient to the conditions of his pathology or to prevent complications. The curative surgery restores the physiological circulation, the iterative surgery treats a complication or a degeneration appearing after a curative surgery. Patients undergoing cardiac surgery frequently receive blood products transfusions during the preoperative, intraoperative, or postoperative periods. Several observational studies have shown that in cardiac surgery, the transfusion of blood derivatives is associated with an increase in post-operative morbidity and mortality. The objective of this study is to analyze the predictive factors of transfusion in congenital patients operated in adulthood at Brugmann University Hospital, depending on the type of surgery applied (palliative, curative or iterative). The secondary objective will be to assess whether there are any differences with the predictive factors identified in non-congenital patients undergoing cardiac surgery, which could potentially alter the transfusion approach in congenital patients.

Interventions

OTHERData extraction in medical files

Data extraction from medical files, countraverified by the bloodbank database for accuracy.

Sponsors

Pierre Wauthy
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum

Inclusion criteria

Cardiac surgery linked to the presence of a heart congenital malformation.

Exclusion criteria

Transfusion refusal from the patient

Design outcomes

Primary

MeasureTime frameDescription
Demographic data10 yearsDemographic characteristics of the patients (descriptive analysis)
Co-morbidities10 yearsList of co-morbidities (descriptive analysis)
Type of surgery10 yearsType of cardiac surgery
Blood loss during surgery10 yearsBlood loss during surgery
Complications during surgery10 yearsComplications during surgery: descriptive analysis
Complications after surgery10 yearsComplications after surgery: descriptive analysis

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026