Pediatric Cardiac SurgeryNCT04456751
Is Redo Pediatric Cardiac Surgery a Risk Factor for Transfusion?
An observational study of Pediatric Cardiac Surgery and Transfusion, run by Brugmann University Hospital at 1 site in Belgium.
Trial summary
In pediatric cardiac surgery, transfusion requirements are associated with age, development status, pathology, type of surgical intervention and extracorporeal bypass. In adult cardiac surgery, reinterventions (redo)are clearly linked to higher transfusion rates. Read more about this study
- Who is it for?
- Ages Up to 16 years
- Conditions the study is for
- Pediatric Cardiac Surgery, Transfusion
- What is being tested?
- Redo op
- How many people
- 2,439 participants
- Where
- 1 siteBelgium
- Study dates
- 2 Jul 2020to 15 Aug 2020
- 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 Up to 16 years
- All sexes
- Child
Study population: All patients between 0 and 16 years undergoing cardiac surgery with cardiopulmonary bypass in our institution. We will exclude Jehovah's witness patient as they refuse a transfusion.
Who may be able to join
- Patients between 0 and 16 years
- Cardiac surgery with cardiopulmonary bypass
Who cannot join
- Jehova's witness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is a Reintervention for Pediatric Cardiac Surgery Associated With Higher Blood Transfusion Requirements ?
In pediatric cardiac surgery, transfusion requirements are associated with age, development status, pathology, type of surgical intervention and extracorporeal bypass. In adult cardiac surgery, reinterventions (redo)are clearly linked to higher transfusion rates. The investigators want to study if this association is also true in pediatric cardiac surgery.
Read the detailed description
Whereas in adult cardiac surgery, redo-interventions are clearly linked to a higher transfusion rate, this is not really known in paediatric cardiac surgery. In this retrospective study, the investigators will analyse our database for paediatric cardiac surgery patients aged 0-16 years and operated between 2002 and 2017. Patients with a single cardiac surgery will be compared to patients with a second cardiac operation under extracorporeal bypass. The investigators will test the variables for normal distribution using a Shapiro-Wilk test. Non normal distributed variables will be compared by a non-parametric test (Mann Whitney U), frequency analysis will be done by a Chi-Square test. A univariate analysis will determine predicting factors for transfusion. Factors with a P value < 0.1 will be analysed by a multivariate analysis to determine independent factors for transfusion. Odds with 95% confidence intervals will be calculated. A P value < 0.05 will be considered statistically significant.
- Conditions
- Pediatric Cardiac Surgery, Transfusion
- Being tested
- Redo op
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Redo opOther
Patients with a redo operation
| Study group | Role | What they receive |
|---|---|---|
| No redo op | Patients with a single cardiac operation under extracorporeal bypass | |
| Redo op | Patients with a redo cardiac operation under extracorporeal bypass Receives: Other: Redo op |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transfusion of packed red cells (mL/kg)
Transfusion requirements will be measured as volume of packed red cells given as mL packed red cells/kg of body weight
Measured: Day of operation up to 5 days postop
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2020
- Study start2 Jul 2020
- Primary completion15 Aug 2020
- Study completion15 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Cardiac SurgeryStudies 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
- 2,439 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brugmann University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Denis SCHMARTZ, Brugmann University Hospital
- Investigators
- Denis Schmartz, MD, Principal investigator, CHU Brugmann
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04456751
- Sponsor's protocol ID
- CHUB_redoped
- Status last verified
- Aug 2020
- First submitted
- 25 Jun 2020
- Last updated
- 26 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is a Reintervention for Pediatric Cardiac Surgery Associated With Higher Blood Transfusion Requirements ?
- ClinicalTrials.gov ID
- NCT04456751
- Acronym / sponsor ID
- CHUB_redoped
- Conditions
- Pediatric Cardiac Surgery, Transfusion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,439 participants (actual)
- Lead sponsor
- Brugmann University HospitalUniversity, hospital or other
- Study start
- 2 Jul 2020 (actual)
- Primary completion
- 15 Aug 2020 (actual)
- Study completion
- 15 Aug 2020 (actual)
- First posted
- 2 Jul 2020 (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.
In pediatric cardiac surgery, transfusion requirements are associated with age, development status, pathology, type of surgical intervention and extracorporeal bypass. In adult cardiac surgery, reinterventions (redo)are clearly linked to higher transfusion rates. The investigators want to study if this association is also true in pediatric cardiac surgery.
Detailed description
Whereas in adult cardiac surgery, redo-interventions are clearly linked to a higher transfusion rate, this is not really known in paediatric cardiac surgery. In this retrospective study, the investigators will analyse our database for paediatric cardiac surgery patients aged 0-16 years and operated between 2002 and 2017. Patients with a single cardiac surgery will be compared to patients with a second cardiac operation under extracorporeal bypass. The investigators will test the variables for normal distribution using a Shapiro-Wilk test. Non normal distributed variables will be compared by a non-parametric test (Mann Whitney U), frequency analysis will be done by a Chi-Square test. A univariate analysis will determine predicting factors for transfusion. Factors with a P value < 0.1 will be analysed by a multivariate analysis to determine independent factors for transfusion. Odds with 95% confidence intervals will be calculated. A P value < 0.05 will be considered statistically significant.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No redo op | – | –Patients with a single cardiac operation under extracorporeal bypass |
| Redo op | – | Other: Redo opPatients with a redo cardiac operation under extracorporeal bypass |
Who may qualify
- Ages
- Up to 16 years
- Sex
- All
- Age groups
- Child
- Study population
- All patients between 0 and 16 years undergoing cardiac surgery with cardiopulmonary bypass in our institution. We will exclude Jehovah's witness patient as they refuse a transfusion.
Key inclusion criteria (2 listed)
- Patients between 0 and 16 years
- Cardiac surgery with cardiopulmonary bypass
Key exclusion criteria (1 listed)
- Jehova's witness
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 |
|---|---|---|
| Redo opPatients with a redo operation | Other | Redo op |
Primary outcome
Transfusion of packed red cells (mL/kg)
Time frame: Day of operation up to 5 days postop
Transfusion requirements will be measured as volume of packed red cells given as mL packed red cells/kg of body weight
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 26 Aug 2020.
- 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.
Denis Schmartz, MD principal investigator
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 Pediatric Cardiac Surgery and Transfusion, 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 2 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 26 Aug 2020. 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?
Transfusion of packed red cells (mL/kg) (time frame: Day of operation up to 5 days postop). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Aug 2020; AzTrials last refreshed its copy on 31 Oct 2026.