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NCT Number: NCT03063801

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

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.

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Key information

Conditions

Congenital Heart Defect Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Brugmann

Brussels, 1020, Belgium

Who can participate

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

Inclusion criteria

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

Exclusion criteria

Transfusion refusal from the patient

Treatment and study plan

Data extraction in medical files

Other

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

Primary outcomes

  1. Demographic data

    Time frame: 10 years

    Demographic characteristics of the patients (descriptive analysis)

  2. Co-morbidities

    Time frame: 10 years

    List of co-morbidities (descriptive analysis)

  3. Type of surgery

    Time frame: 10 years

    Type of cardiac surgery

  4. Blood loss during surgery

    Time frame: 10 years

    Blood loss during surgery

  5. Complications during surgery

    Time frame: 10 years

    Complications during surgery: descriptive analysis

  6. Complications after surgery

    Time frame: 10 years

    Complications after surgery: descriptive analysis

Sponsors and collaborators

Lead sponsor

Pierre Wauthy

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Feb 24, 2017
Registry last updated
Nov 22, 2017

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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