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

NCT03063801 | Completed

• 1 other identifier: CHUB-transfusion management
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Congenital Heart Defect

Keywords

Congenital Heart Disease; Blood products transfusion

Outcome Measures

Primary Outcomes (6)

• Demographic data

  Demographic characteristics of the patients (descriptive analysis)

  10 years

• Co-morbidities

  List of co-morbidities (descriptive analysis)

  10 years

• Type of surgery

  Type of cardiac surgery

  10 years

• Blood loss during surgery

  Blood loss during surgery

  10 years

• Complications during surgery

  Complications during surgery: descriptive analysis

  10 years

• Complications after surgery

  Complications after surgery: descriptive analysis

  10 years

Study Arms (1)

Cardiac surgery

All adult patients having undergone surgery between January 2006 and December 2016 within the CHU Brugmann hospital.

Other: Data extraction in medical files

Interventions

Data extraction in medical files OTHER

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

Cardiac surgery

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All adult patients having had cardiac surgery within the CHU Brugmann hospital, between January 2006 and December 2016.

You may qualify if:

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

You may not qualify if:

• Transfusion refusal from the patient

Sponsors & Collaborators

• Pierre Wauthy: lead

Study Sites (1)

CHU Brugmann

Brussels, 1020, Belgium

Location

Related Publications (7)

• 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.

  PMID: 20923595 BACKGROUND

• Somerville J. Management of adults with congenital heart disease: an increasing problem. Annu Rev Med. 1997;48:283-93. doi: 10.1146/annurev.med.48.1.283.

  PMID: 9046962 BACKGROUND

• 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. doi: 10.1016/j.athoracsur.2007.02.099.

  PMID: 17462454 BACKGROUND

• 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;2014(2):CD009752. doi: 10.1002/14651858.CD009752.pub2.

  PMID: 24510598 BACKGROUND

• 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.

  PMID: 24968768 BACKGROUND

• 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.

  PMID: 21986279 BACKGROUND

• 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.

  PMID: 19442530 BACKGROUND

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Aurélie Copin

  CHU Brugmann

  PRINCIPAL INVESTIGATOR

• Pierre Wauthy, MD

  CHU Brugmann

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of clinic

Study Record Dates

• First Submitted: February 21, 2017
• First Posted: February 24, 2017
• Study Start: April 1, 2017
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: November 22, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)