Congenital Heart DefectNCT03063801
Study on the Transfusional Management of the Patients With Congenital Heart Disease Carried Out in Adulthood.
An observational study of Congenital Heart Defect, run by Pierre Wauthy at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Congenital Heart Defect
- What is being tested?
- Data extraction in medical files
- How many people
- 300 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Apr 2017to 1 Jun 2017
- 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
- Child, Adult, Older adult
Study population: All adult patients having had cardiac surgery within the CHU Brugmann hospital, between January 2006 and December 2016.
Who may be able to join
- Cardiac surgery linked to the presence of a heart congenital malformation.
Who cannot join
- Transfusion refusal from the patient
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observational Retrospective 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.
Read more
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
- Being tested
- Data extraction in medical files
- Keywords
- Congenital Heart Disease, Blood products transfusion
- 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.
Data extraction in medical filesOther
Data extraction from medical files, countraverified by the bloodbank database for accuracy.
| Study group | Role | What they receive |
|---|---|---|
| Cardiac surgery | All adult patients having undergone surgery between January 2006 and December 2016 within the CHU Brugmann hospital. Receives: Other: Data extraction in medical files |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demographic data
Demographic characteristics of the patients (descriptive analysis)
Measured: 10 years
Co-morbidities
List of co-morbidities (descriptive analysis)
Measured: 10 years
Type of surgery
Type of cardiac surgery
Measured: 10 years
Blood loss during surgery
Blood loss during surgery
Measured: 10 years
Complications during surgery
Complications during surgery: descriptive analysis
Measured: 10 years
Complications after surgery
Complications after surgery: descriptive analysis
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2017
- Study start1 Apr 2017
- Primary completion1 Jun 2017
- Study completion1 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Congenital Heart DefectStudies 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
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pierre Wauthy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Pierre Wauthy, Brugmann University Hospital
- Investigators
- Aurélie Copin, Principal investigator, CHU BrugmannPierre Wauthy, MD, Study director, CHU Brugmann
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03063801
- Sponsor's protocol ID
- CHUB-transfusion management
- Status last verified
- Nov 2017
- First submitted
- 21 Feb 2017
- Last updated
- 22 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 20923595Somerville 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.
PubMed 9046962Society 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.
PubMed 17462454Wilkinson 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 24510598Mulaj 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.
PubMed 24968768Zomer 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.
PubMed 21986279Loup 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.
PubMed 19442530
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Retrospective Study on the Transfusional Management of the Patients With Congenital Heart Disease Carried Out in Adulthood.
- ClinicalTrials.gov ID
- NCT03063801
- Acronym / sponsor ID
- CHUB-transfusion management
- Conditions
- Congenital Heart Defect
- Keywords
- Congenital Heart Disease, Blood products transfusion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Pierre WauthyUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 1 Jun 2017 (actual)
- Study completion
- 1 Jun 2017 (actual)
- First posted
- 24 Feb 2017 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiac surgery | – | Other: Data extraction in medical filesAll adult patients having undergone surgery between January 2006 and December 2016 within the CHU Brugmann hospital. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- All adult patients having had cardiac surgery within the CHU Brugmann hospital, between January 2006 and December 2016.
Key inclusion criteria (1 listed)
- Cardiac surgery linked to the presence of a heart congenital malformation.
Key exclusion criteria (1 listed)
- Transfusion refusal from the patient
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 |
|---|---|---|
| Data extraction in medical filesData extraction from medical files, countraverified by the bloodbank database for accuracy. | Other | Cardiac surgery |
Primary outcome
Demographic data
Time frame: 10 years
Demographic characteristics of the patients (descriptive analysis)
Co-morbidities
Time frame: 10 years
List of co-morbidities (descriptive analysis)
Type of surgery
Time frame: 10 years
Type of cardiac surgery
Blood loss during surgery
Time frame: 10 years
Blood loss during surgery
Complications during surgery
Time frame: 10 years
Complications during surgery: descriptive analysis
Complications after surgery
Time frame: 10 years
Complications after surgery: descriptive analysis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2017.
- Background: PubMed 20923595Wauthy 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.
- Background: PubMed 9046962Somerville 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.
- Background: PubMed 17462454Society 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.
- 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 24968768Mulaj 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.
- Background: PubMed 21986279Zomer 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.
- Background: PubMed 19442530Loup 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.
- 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.
Aurélie Copin principal investigator
CHU Brugmann
Pierre Wauthy, MD study director
CHU Brugmann
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 Defect, run by Pierre Wauthy 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 1 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: finished, as of the sponsor's last update on 22 Nov 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demographic data (time frame: 10 years). The study lists 6 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 NCT03063801, which also lists 7 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 22 Nov 2017.