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

Congenital Heart Defect Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03063801
• Other study ID #: CHUB-transfusion management
• Status: Completed
• Phase: N/A
• First received: February 21, 2017
• Last updated: November 20, 2017
• Start date: April 1, 2017
• Est. completion date: June 1, 2017

Study information

• Verified date: November 2017
• Source: Brugmann University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: June 1, 2017
• Est. primary completion date: June 1, 2017
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Transfusion refusal from the patient

Related Conditions & MeSH terms

• Congenital Heart Defect
• Heart Defects, Congenital
• Heart Diseases

Intervention

Other:
• Data extraction in medical files
Data extraction from medical files, countraverified by the bloodbank database for accuracy.

Locations

Country	Name	City	State
Belgium	CHU Brugmann	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Pierre Wauthy

Country where clinical trial is conducted

Belgium, 

References & Publications (7)

Loup O, von Weissenfluh C, Gahl B, Schwerzmann M, Carrel T, Kadner A. Quality of life of grown-up congenital heart disease patients after congenital cardiac surgery. Eur J Cardiothorac Surg. 2009 Jul;36(1):105-11; discussion 111. doi: 10.1016/j.ejcts.2009.03.023. Epub 2009 May 12. — View Citation

Mulaj M, Faraoni D, Willems A, Sanchez Torres C, Van der Linden P. Predictive factors for red blood cell transfusion in children undergoing noncomplex cardiac surgery. Ann Thorac Surg. 2014 Aug;98(2):662-7. doi: 10.1016/j.athoracsur.2014.04.089. Epub 2014 Jun 24. — View Citation

Society of Thoracic Surgeons Blood Conservation Guideline Task Force, Ferraris VA, Ferraris SP, Saha SP, Hessel EA 2nd, Haan CK, Royston BD, Bridges CR, Higgins RS, Despotis G, Brown JR; Society of Cardiovascular Anesthesiologists Special Task Force on Blood Transfusion, Spiess BD, Shore-Lesserson L, Stafford-Smith M, Mazer CD, Bennett-Guerrero E, Hill SE, Body S. Perioperative blood transfusion and blood conservation in cardiac surgery: the Society of Thoracic Surgeons and The Society of Cardiovascular Anesthesiologists clinical practice guideline. Ann Thorac Surg. 2007 May;83(5 Suppl):S27-86. Review. — View Citation

Somerville J. Management of adults with congenital heart disease: an increasing problem. Annu Rev Med. 1997;48:283-93. Review. — View Citation

Wauthy P, Massaut J, Sanoussi A, Demanet H, Morissens M, Damry N, Dessy H, Malekzadeh-Milani SG, Deuvaert FE. Ten-year experience with surgical treatment of adults with congenital cardiac disease. Cardiol Young. 2011 Feb;21(1):39-45. doi: 10.1017/S1047951110001332. Epub 2010 Oct 6. — View Citation

Wilkinson KL, Brunskill SJ, Doree C, Trivella M, Gill R, Murphy MF. Red cell transfusion management for patients undergoing cardiac surgery for congenital heart disease. Cochrane Database Syst Rev. 2014 Feb 7;(2):CD009752. doi: 10.1002/14651858.CD009752.pub2. Review. — View Citation

Zomer AC, Verheugt CL, Vaartjes I, Uiterwaal CS, Langemeijer MM, Koolbergen DR, Hazekamp MG, van Melle JP, Konings TC, Bellersen L, Grobbee DE, Mulder BJ. Surgery in adults with congenital heart disease. Circulation. 2011 Nov 15;124(20):2195-201. doi: 10.1161/CIRCULATIONAHA.111.027763. Epub 2011 Oct 10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Demographic data	Demographic characteristics of the patients (descriptive analysis)	10 years
Primary	Co-morbidities	List of co-morbidities (descriptive analysis)	10 years
Primary	Type of surgery	Type of cardiac surgery	10 years
Primary	Blood loss during surgery	Blood loss during surgery	10 years
Primary	Complications during surgery	Complications during surgery: descriptive analysis	10 years
Primary	Complications after surgery	Complications after surgery: descriptive analysis	10 years