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

NCT03063801 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2017-11-22

No results posted yet for this study

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.

Conditions

  • Congenital Heart Defect

Interventions

OTHER

Data extraction in medical files

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

Sponsors & Collaborators

  • Pierre Wauthy

    lead OTHER

Principal Investigators

  • Aurélie Copin · CHU Brugmann

  • Pierre Wauthy, MD · CHU Brugmann

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-01
Primary Completion
2017-06-01
Completion
2017-06-01

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03063801 on ClinicalTrials.gov