Congenital Heart DiseaseNCT04973514
Perioperative Transfusion Strategies in Adult Congenital Heart Disease Patients Undergoing Cardiac Surgery
An observational study of Congenital Heart Disease and Cardiac Surgery, run by Brugmann University Hospital at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Congenital Heart Disease, Cardiac Surgery, Blood Transfusion
- What is being tested?
- Cardiac surgery in grown-up congenital heart disease patients
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 1 siteBelgium
- Study dates
- 20 Jul 2022to 30 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All adult congenital heart disease patients undergoing cardiac surgery with cardiopulmonary bypass between 2000 and 2020 at Brugmann University Hospital
Who may be able to join
- All adult congenital heart disease patients undergoing cardiac surgery with cardiopulmonary bypass between 2000 and 2020 at Brugmann University Hospital
Who cannot join
- Off-pump cardiac surgery
- re-intervention within 30 days of cardiac surgery due to complications
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Perioperative Transfusion Strategies in Adult Congenital Heart Disease Patients Undergoing Cardiac Surgery, Impact on Outcome
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.
Read the detailed description
Introduction: About 1% of newborns in Belgium have a congenital heart defect. The improvement of intra- and postoperative treatment and the development of new surgical techniques have allowed an increasing management of congenital heart pathologies, making it possible to successfully treat approximately 95% of children with these conditions. The increase in life expectancy of these children has resulted in an ever-increasing proportion of this population reaching adulthood.
Most patients with congenital heart disease, particularly cyanotic conditions, require specialized follow-up in a referral center, given the risk of late complications related to correction or palliation of the primary condition.
Reoperations in adulthood pose a number of challenges for the multidisciplinary team managing these patients: more complex surgical approach (adhesions, altered in situ anatomy, development of collateral circulation, persistence of intra- or extra-cardiac shunts...). The operative risk but also the infectious risk are clearly increased in this population.
The risk of bleeding, which is already high in cardiac surgery, particularly due to the use of extracorporeal circulation, is also increased by the re-intervention itself. This is potentially accompanied by greater exposure to allogeneic blood products, which has been associated with increased postoperative morbidity and mortality.
Various techniques have been developed to reduce the risk of bleeding in cardiac surgery, including the use of anti-fibrinolytic agents, avoidance of deep hypothermia, reduction of vascular filling to avoid excessive hemodilution, and application of a permissive hypotension and restrictive transfusion strategy. The ultimate goal of integrating these techniques into our transfusion practices is to improve patient outcomes by reducing exposure to blood products. There are currently no recommendations on good transfusion practices for the management of these patients with congenital heart disease who require cardiac re-intervention in adulthood. There are also few studies specific to this population in the current literature.
Objectives: The main objective of the study is to analyze, in our center, if the transfusion practices (measures to decrease the risk of bleeding, transfusion of red blood cells (RBCs) and/or blood derivatives), in patients who have had a re-intervention of congenital heart surgery, are determinant to reduce morbidity and mortality in the following 30 days and 6 months Type of study and design: Retrospective and descriptive study by extraction of patients who underwent cardiac surgery, at the Brugmann University Hospital, between the year 2000 to the year 2020, by analysis of the medical charts.
Patients: Grown-up congenital heart disease patients re-operated from cardiac surgery between January 2000 to December 2020.
Inclusion criteria: All patients with congenital heart disease reoperated from a new cardiac surgery under extracorporeal circulation, at Brugmann University Hospital, between the year 2000 to the year 2020.
Exclusion criteria: Patients with cardiac surgery without cardiopulmonary bypass, patients with acquired heart disease, patients who had a re-intervention due to a complication within 30 days postoperatively.
Statistical evaluation: Descriptive analyses will be used and further analyses will be performed based on preliminary results and hypotheses raised. The patients' data will be put in an anonymized file and analyzed later.
Variables to be collected: demographic data; type of procedure; personal history of the patient; clinical symptomatology; pre-op, intra-op and post-op treatment; complementary pre-, per-, and post-op examinations (radiological, laboratories), operative data (surgical procedure performed, blood loss, blood component transfusion (red blood cells, platelets, plasma), fluid balance, use of anti-fibrinolytics) ; hemodynamic monitoring (intraoperative vital parameters), duration of cardiopulmonary bypasss (CPB) time, aortic clamping time, intraoperative and postoperative complications, death, length of stay in intensive care and total length of stay.
- Being tested
- Cardiac surgery in grown-up congenital heart disease patients
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac surgery in grown-up congenital heart disease patientsProcedure or surgery
Analysis of patient blood management, influence on 30 day and 6 month outcome
What is being measured
The primary outcome is the main question the study is designed to answer.
Outcome 30 day
Outcome at 30 days postoperative, defined as new organ failure or death
Measured: 30 days
Outcome 6 months
Outcome at 6 months postoperatively, defined as new organ failure or death
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2021
- Study start20 Jul 2022 (estimated)
- Primary completion30 Sep 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brugmann University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Denis SCHMARTZ, Brugmann University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04973514
- Sponsor's protocol ID
- CHUB_GUCHD
- Status last verified
- Mar 2022
- First submitted
- 23 Apr 2021
- Last updated
- 1 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 22984760Webb 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.
PubMed 11243519Dore 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.
PubMed 9382007Rychik 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.
PubMed 31256636Haapanen 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.
PubMed 32147413Talwar 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.
PubMed 27625519Berdat 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.
PubMed 14975553Vida 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.
PubMed 17184653Brevig 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.
PubMed 19161774Kuduvalli 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.
PubMed 15784356Wilkinson 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.
PubMed 24510598Giamberti 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.
PubMed 19766822
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Transfusion Strategies in Adult Congenital Heart Disease Patients Undergoing Cardiac Surgery, Impact on Outcome
- ClinicalTrials.gov ID
- NCT04973514
- Acronym / sponsor ID
- CHUB_GUCHD
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Brugmann University HospitalUniversity, hospital or other
- Study start
- 20 Jul 2022 (estimated)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 22 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Introduction: About 1% of newborns in Belgium have a congenital heart defect. The improvement of intra- and postoperative treatment and the development of new surgical techniques have allowed an increasing management of congenital heart pathologies, making it possible to successfully treat approximately 95% of children with these conditions. The increase in life expectancy of these children has resulted in an ever-increasing proportion of this population reaching adulthood.
Most patients with congenital heart disease, particularly cyanotic conditions, require specialized follow-up in a referral center, given the risk of late complications related to correction or palliation of the primary condition.
Reoperations in adulthood pose a number of challenges for the multidisciplinary team managing these patients: more complex surgical approach (adhesions, altered in situ anatomy, development of collateral circulation, persistence of intra- or extra-cardiac shunts...). The operative risk but also the infectious risk are clearly increased in this population.
The risk of bleeding, which is already high in cardiac surgery, particularly due to the use of extracorporeal circulation, is also increased by the re-intervention itself. This is potentially accompanied by greater exposure to allogeneic blood products, which has been associated with increased postoperative morbidity and mortality.
Various techniques have been developed to reduce the risk of bleeding in cardiac surgery, including the use of anti-fibrinolytic agents, avoidance of deep hypothermia, reduction of vascular filling to avoid excessive hemodilution, and application of a permissive hypotension and restrictive transfusion strategy. The ultimate goal of integrating these techniques into our transfusion practices is to improve patient outcomes by reducing exposure to blood products. There are currently no recommendations on good transfusion practices for the management of these patients with congenital heart disease who require cardiac re-intervention in adulthood. There are also few studies specific to this population in the current literature.
Objectives: The main objective of the study is to analyze, in our center, if the transfusion practices (measures to decrease the risk of bleeding, transfusion of red blood cells (RBCs) and/or blood derivatives), in patients who have had a re-intervention of congenital heart surgery, are determinant to reduce morbidity and mortality in the following 30 days and 6 months Type of study and design: Retrospective and descriptive study by extraction of patients who underwent cardiac surgery, at the Brugmann University Hospital, between the year 2000 to the year 2020, by analysis of the medical charts.
Patients: Grown-up congenital heart disease patients re-operated from cardiac surgery between January 2000 to December 2020.
Inclusion criteria: All patients with congenital heart disease reoperated from a new cardiac surgery under extracorporeal circulation, at Brugmann University Hospital, between the year 2000 to the year 2020.
Exclusion criteria: Patients with cardiac surgery without cardiopulmonary bypass, patients with acquired heart disease, patients who had a re-intervention due to a complication within 30 days postoperatively.
Statistical evaluation: Descriptive analyses will be used and further analyses will be performed based on preliminary results and hypotheses raised. The patients' data will be put in an anonymized file and analyzed later.
Variables to be collected: demographic data; type of procedure; personal history of the patient; clinical symptomatology; pre-op, intra-op and post-op treatment; complementary pre-, per-, and post-op examinations (radiological, laboratories), operative data (surgical procedure performed, blood loss, blood component transfusion (red blood cells, platelets, plasma), fluid balance, use of anti-fibrinolytics) ; hemodynamic monitoring (intraoperative vital parameters), duration of cardiopulmonary bypasss (CPB) time, aortic clamping time, intraoperative and postoperative complications, death, length of stay in intensive care and total length of stay.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All adult congenital heart disease patients undergoing cardiac surgery with cardiopulmonary bypass between 2000 and 2020 at Brugmann University Hospital
Key inclusion criteria (1 listed)
- All adult congenital heart disease patients undergoing cardiac surgery with cardiopulmonary bypass between 2000 and 2020 at Brugmann University Hospital
Key exclusion criteria (2 listed)
- Off-pump cardiac surgery
- re-intervention within 30 days of cardiac surgery due to complications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac surgery in grown-up congenital heart disease patientsAnalysis of patient blood management, influence on 30 day and 6 month outcome | Procedure or surgery | – |
Primary outcome
Outcome 30 day
Time frame: 30 days
Outcome at 30 days postoperative, defined as new organ failure or death
Outcome 6 months
Time frame: 6 month
Outcome at 6 months postoperatively, defined as new organ failure or death
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2022.
- Background: PubMed 22984760Miltner 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.
- Background: PubMed 11243519Webb 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.
- Background: PubMed 9382007Dore 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.
- Background: PubMed 31256636Rychik 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.
- Background: PubMed 32147413Haapanen 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.
- Background: PubMed 27625519Talwar 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.
- Background: PubMed 14975553Berdat 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.
- Background: PubMed 17184653Vida 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.
- Background: PubMed 19161774Brevig 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.
- Background: PubMed 15784356Kuduvalli 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.
- Background: PubMed 24510598Wilkinson 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.
- Background: PubMed 19766822Giamberti 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Heart Disease and Cardiac Surgery, run by Brugmann University Hospital at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Denis Schmartz, MD (+3224773996, denis.schmartz@chu-brugmann.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Outcome 30 day (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04973514, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2022.