NCT04973514

Brief Summary

Due to better medical care, a growing number of patients with congenital heart disease reach adulthood. A large number of these patients needs a redo cardiac surgery. No guidelines of best transfusion practice exist for this patient population. A retrospective analysis of all adult patients with congenital heart disease undergoing cardiac surgery between 2000 and 2020 will be performed. Transfusion practices and their influence on outcome at 30 days and 6 month will be evaluated.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 23, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 22, 2021

Completed
12 months until next milestone

Study Start

First participant enrolled

July 20, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

April 1, 2022

Status Verified

March 1, 2022

Enrollment Period

2 months

First QC Date

April 23, 2021

Last Update Submit

March 31, 2022

Conditions

Congenital Heart DiseaseCardiac SurgeryBlood TransfusionMorbidity, Multiple

Outcome Measures

Primary Outcomes (2)

  • Outcome 30 day

    Outcome at 30 days postoperative, defined as new organ failure or death

    30 days

  • Outcome 6 months

    Outcome at 6 months postoperatively, defined as new organ failure or death

    6 month

Interventions

Cardiac surgery in grown-up congenital heart disease patientsPROCEDURE

Analysis of patient blood management, influence on 30 day and 6 month outcome

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All adult congenital heart disease patients undergoing cardiac surgery with cardiopulmonary bypass between 2000 and 2020 at Brugmann University Hospital

You may qualify if:

  • All adult congenital heart disease patients undergoing cardiac surgery with cardiopulmonary bypass between 2000 and 2020 at Brugmann University Hospital

You may not qualify if:

  • Off-pump cardiac surgery
  • re-intervention within 30 days of cardiac surgery due to complications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Brugmann

Brussels, 1020, Belgium

Location

Related Publications (12)

  • Miltner B, Pierard L, Seghaye MC. [Follow up of adults with congenital heart disease]. Rev Med Liege. 2012 Jul-Aug;67(7-8):407-12. French.

    PMID: 22984760BACKGROUND

  • Webb GD. Care of adults with congenital heart disease--a challenge for the new millennium. Thorac Cardiovasc Surg. 2001 Feb;49(1):30-4. doi: 10.1055/s-2001-9918.

    PMID: 11243519BACKGROUND

  • Dore A, Glancy DL, Stone S, Menashe VD, Somerville J. Cardiac surgery for grown-up congenital heart patients: survey of 307 consecutive operations from 1991 to 1994. Am J Cardiol. 1997 Oct 1;80(7):906-13. doi: 10.1016/s0002-9149(97)00544-4.

    PMID: 9382007BACKGROUND

  • Rychik J, Atz AM, Celermajer DS, Deal BJ, Gatzoulis MA, Gewillig MH, Hsia TY, Hsu DT, Kovacs AH, McCrindle BW, Newburger JW, Pike NA, Rodefeld M, Rosenthal DN, Schumacher KR, Marino BS, Stout K, Veldtman G, Younoszai AK, d'Udekem Y; American Heart Association Council on Cardiovascular Disease in the Young and Council on Cardiovascular and Stroke Nursing. Evaluation and Management of the Child and Adult With Fontan Circulation: A Scientific Statement From the American Heart Association. Circulation. 2019 Aug 6;140(6):e234-e284. doi: 10.1161/CIR.0000000000000696. Epub 2019 Jul 1.

    PMID: 31256636BACKGROUND

  • Haapanen H, Tsang V, Kempny A, Neijenhuis R, Kennedy F, Cullen S, Walker F, Kostolny M, Hsia TY, Van Doorn C. Grown-up Congenital Heart Surgery in 1093 Consecutive Cases: A "Hidden" Burden of Early Outcome. Ann Thorac Surg. 2020 Nov;110(5):1667-1676. doi: 10.1016/j.athoracsur.2020.01.071. Epub 2020 Mar 5.

    PMID: 32147413BACKGROUND

  • Talwar S, Kumar MV, Sreenivas V, Choudhary SK, Sahu M, Airan B. Factors determining outcomes in grown up patients operated for congenital heart diseases. Ann Pediatr Cardiol. 2016 Sep-Dec;9(3):222-8. doi: 10.4103/0974-2069.189113.

    PMID: 27625519BACKGROUND

  • Berdat PA, Immer F, Pfammatter JP, Carrel T. Reoperations in adults with congenital heart disease: analysis of early outcome. Int J Cardiol. 2004 Feb;93(2-3):239-45. doi: 10.1016/j.ijcard.2003.04.005.

    PMID: 14975553BACKGROUND

  • Vida VL, Berggren H, Brawn WJ, Daenen W, Di Carlo D, Di Donato R, Lindberg HL, Corno AF, Fragata J, Elliott MJ, Hraska V, Kiraly L, Lacour-Gayet F, Maruszewski B, Rubay J, Sairanen H, Sarris G, Urban A, Van Doorn C, Ziemer G, Stellin G. Risk of surgery for congenital heart disease in the adult: a multicentered European study. Ann Thorac Surg. 2007 Jan;83(1):161-8. doi: 10.1016/j.athoracsur.2006.07.045.

    PMID: 17184653BACKGROUND

  • Brevig J, McDonald J, Zelinka ES, Gallagher T, Jin R, Grunkemeier GL. Blood transfusion reduction in cardiac surgery: multidisciplinary approach at a community hospital. Ann Thorac Surg. 2009 Feb;87(2):532-9. doi: 10.1016/j.athoracsur.2008.10.044.

    PMID: 19161774BACKGROUND

  • Kuduvalli M, Oo AY, Newall N, Grayson AD, Jackson M, Desmond MJ, Fabri BM, Rashid A. Effect of peri-operative red blood cell transfusion on 30-day and 1-year mortality following coronary artery bypass surgery. Eur J Cardiothorac Surg. 2005 Apr;27(4):592-8. doi: 10.1016/j.ejcts.2005.01.030.

    PMID: 15784356BACKGROUND

  • 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: 24510598BACKGROUND

  • Giamberti A, Chessa M, Abella R, Butera G, Carlucci C, Nuri H, Frigiola A, Ranucci M. Morbidity and mortality risk factors in adults with congenital heart disease undergoing cardiac reoperations. Ann Thorac Surg. 2009 Oct;88(4):1284-9. doi: 10.1016/j.athoracsur.2009.05.060.

    PMID: 19766822BACKGROUND

MeSH Terms

Conditions

Heart Defects, Congenital

Interventions

Cardiac Surgical Procedures

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Cardiovascular Surgical ProceduresSurgical Procedures, OperativeThoracic Surgical Procedures

Central Study Contacts

Denis Schmartz, MD

CONTACT

+3224773996denis.schmartz@chu-brugmann.be

Philippe Van der Linden, MD, PhD

CONTACT

+3224773996philippe.vanderlinden@chu-brugmann.be

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesiologists, Head of department

Study Record Dates

First Submitted

April 23, 2021

First Posted

July 22, 2021

Study Start

July 20, 2022

Primary Completion

September 30, 2022

Study Completion

December 30, 2022

Last Updated

April 1, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)