Congenital Heart DiseaseNCT05881564
Blood Conservation in Patients (3.5-12kg) Undergoing Congenital Cardiac Surgery
A study testing blood use for priming cardiopulmonary bypass circuit and clear prime for cardiopulmonary bypass in people with Congenital Heart Disease, run by Augusta University at 1 site in United States.
Trial summary
To evaluate if there is any clinical difference in patients 3.5-12kg who undergo cardiac surgery with cardiopulmonary bypass that do and do not receive blood products as part of their procedure. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Congenital Heart Disease
- What is being tested?
- blood use for priming cardiopulmonary bypass circuit and clear prime for cardiopulmonary bypass
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 10 May 2023to 12 May 2026
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient weight 3.5-12kg
- Elective and urgent cardiac surgery with cardiopulmonary bypass
- Cases within the STS STAT categories of 1-4
Who cannot join
- Patients who weigh more than 12kg or less than 3.5kg.
- Patients undergoing emergency surgery.
- STAT category 5 cases.
- Patients whose surgery does not require cardiopulmonary bypass.
- Patients presenting preoperatively in shock.
- Patients with known blood dyscrasias.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Children's Hospital of Georgia
Augusta, Georgia, 30912
Lauren Allen, 706-721-7608, lauallen@augusta.edu
Brian Bateson, DO
About this study
Official title: Differences in Outcomes for Patients (3.5-12kg) Undergoing Congenital Cardiac Surgery Who Receive Blood Versus Those Who do Not
To evaluate if there is any clinical difference in patients 3.5-12kg who undergo cardiac surgery with cardiopulmonary bypass that do and do not receive blood products as part of their procedure. The main hypothesis of the study is that the patients undergoing bloodless cardiac surgery will have decreased morbidity and mortality when compared to the cohort that did receive blood as well as a shorter ICU and hospital length of stay.
- Conditions
- Congenital Heart Disease
- Being tested
- blood use for priming cardiopulmonary bypass circuit, clear prime for cardiopulmonary bypass
- 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.
blood use for priming cardiopulmonary bypass circuitOther
one arm will have the cardiopulmonary bypass circuit primed with blood
clear prime for cardiopulmonary bypassOther
this arm will not have bypass circuit primed with blood
| Study group | Role | What they receive |
|---|---|---|
| Blood prime for cardiopulmonary bypass | Active comparator | Not described Receives: Other: blood use for priming cardiopulmonary bypass circuit |
| clear prime for cardiopulmonary bypass | Active comparator | Not described Receives: Other: clear prime for cardiopulmonary bypass |
What is being measured
The primary outcome is the main question the study is designed to answer.
Age of patients undergoing bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
age in months
Measured: 30 days
Weight of patients undergoing bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
weight in kg
Measured: 30 days
Gender of patients undergoing bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
sex
Measured: 30 days
Demographics of bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
race
Measured: 30 days
Diagnosis of patients undergoing bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
preoperative diagnosis
Measured: 30 days
Surgery performed in bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
surgery performed
Measured: 30 days
Previous surgery prior to bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
any previous surgery
Measured: 30 days
Blood received during bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
blood product received
Measured: 30 days
Volume transfused during bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
volume of blood transfusion in mL
Measured: 30 days
Number of patients with unplanned reoperation in bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
unplanned reoperation
Measured: 30 days
Number of patients with unplanned cardiac catheterization in bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
unplanned cardiac catheterization
Measured: 30 days
Number of patients with a neurologic complication in bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
neurologic complication
Measured: 30 days
Number of patients with chylothorax in bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
chylothorax
Measured: 30 days
Number of patients with vocal cord injury in bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
vocal cord injury
Measured: 30 days
Number of patients with diaphragm paralysis in bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
diaphragm paralysis
Measured: 30 days
Number of patients with pacemaker implantation in bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
pacemaker implantation
Measured: 30 days
Number of patients with postoperative pneumothorax in bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
postoperative pneumothorax
Measured: 30 days
Number of patients with wound infection in bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
wound infection
Measured: 30 days
Number of patients with bleeding requiring reoperation in bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
bleeding requiring reoperation
Measured: 30 days
Number of patients with pericardial effusion in bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
pericardial effusion
Measured: 30 days
Number of patients who died following bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
mortality
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2023
- Study start10 May 2023
- Primary completion11 May 2025 (estimated)
- Study completion12 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Augusta University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05881564
- Sponsor's protocol ID
- 2000190-3
- Status last verified
- May 2023
- First submitted
- 10 May 2023
- Last updated
- 1 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 1 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differences in Outcomes for Patients (3.5-12kg) Undergoing Congenital Cardiac Surgery Who Receive Blood Versus Those Who do Not
- ClinicalTrials.gov ID
- NCT05881564
- Acronym / sponsor ID
- 2000190-3
- Conditions
- Congenital Heart Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Augusta UniversityUniversity, hospital or other
- Study start
- 10 May 2023 (actual)
- Primary completion
- 11 May 2025 (estimated)
- Study completion
- 12 May 2026 (estimated)
- First posted
- 31 May 2023 (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.
To evaluate if there is any clinical difference in patients 3.5-12kg who undergo cardiac surgery with cardiopulmonary bypass that do and do not receive blood products as part of their procedure. The main hypothesis of the study is that the patients undergoing bloodless cardiac surgery will have decreased morbidity and mortality when compared to the cohort that did receive blood as well as a shorter ICU and hospital length of stay.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blood prime for cardiopulmonary bypass | Active comparator | Other: blood use for priming cardiopulmonary bypass circuit |
| clear prime for cardiopulmonary bypass | Active comparator | Other: clear prime for cardiopulmonary bypass |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patient weight 3.5-12kg
- Elective and urgent cardiac surgery with cardiopulmonary bypass
- Cases within the STS STAT categories of 1-4
Key exclusion criteria (6 listed)
- Patients who weigh more than 12kg or less than 3.5kg.
- Patients undergoing emergency surgery.
- STAT category 5 cases.
- Patients whose surgery does not require cardiopulmonary bypass.
- Patients presenting preoperatively in shock.
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 |
|---|---|---|
| blood use for priming cardiopulmonary bypass circuitone arm will have the cardiopulmonary bypass circuit primed with blood | Other | Blood prime for cardiopulmonary bypass |
| clear prime for cardiopulmonary bypassthis arm will not have bypass circuit primed with blood | Other | clear prime for cardiopulmonary bypass |
Primary outcome
Age of patients undergoing bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
Time frame: 30 days
age in months
Weight of patients undergoing bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
Time frame: 30 days
weight in kg
Gender of patients undergoing bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
Time frame: 30 days
sex
Demographics of bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
Time frame: 30 days
race
Diagnosis of patients undergoing bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
Time frame: 30 days
preoperative diagnosis
Surgery performed in bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
Time frame: 30 days
surgery performed
Previous surgery prior to bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
Time frame: 30 days
any previous surgery
Blood received during bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
Time frame: 30 days
blood product received
Volume transfused during bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
Time frame: 30 days
volume of blood transfusion in mL
Number of patients with unplanned reoperation in bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
Time frame: 30 days
unplanned reoperation
Number of patients with unplanned cardiac catheterization in bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
Time frame: 30 days
unplanned cardiac catheterization
Number of patients with a neurologic complication in bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
Time frame: 30 days
neurologic complication
Number of patients with chylothorax in bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
Time frame: 30 days
chylothorax
Number of patients with vocal cord injury in bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
Time frame: 30 days
vocal cord injury
Number of patients with diaphragm paralysis in bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
Time frame: 30 days
diaphragm paralysis
Number of patients with pacemaker implantation in bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
Time frame: 30 days
pacemaker implantation
Number of patients with postoperative pneumothorax in bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
Time frame: 30 days
postoperative pneumothorax
Number of patients with wound infection in bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
Time frame: 30 days
wound infection
Number of patients with bleeding requiring reoperation in bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
Time frame: 30 days
bleeding requiring reoperation
Number of patients with pericardial effusion in bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
Time frame: 30 days
pericardial effusion
Number of patients who died following bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
Time frame: 30 days
mortality
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2023.
- Individual participant dataSharing planned: No
Related trials for Congenital Heart Disease
Not yet recruiting
Autologous Thymus Transplant in Children With Congenital Heart Disease: A Pilot Study
Congenital Heart Disease (CHD)
RecruitingPhase 1
A Study of SGT-212 Gene Therapy in Friedreich's Ataxia
Friedreich's Ataxia (FA)
RecruitingObservational study
The CACHE Study: Coronary Artery Care in HaEmophilia
Haemophilia, Cardiovascular Diseases
RecruitingObservational study
Essen Amyloidosis Registry
Amyloidosis; Systemic, Amyloidosis Cardiac
RecruitingPhase 3
Trial Investigating the Efficacy and Safety of Weekly Lonapegsomatropin Compared to Daily Somatropin in Children and Adolescents With Short Stature or Growth Failure Due to Growth Hormone Sufficient Disorders
Turner Syndrome, Short Stature Homeobox Gene Mutation
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?
A study testing blood use for priming cardiopulmonary bypass circuit and clear prime for cardiopulmonary bypass in people with Congenital Heart Disease, run by Augusta University at 1 site in United States.
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 3 inclusion and 6 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 Jun 2023. 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 United States. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Age of patients undergoing bloodless cardiac surgery in patients 3.5-12kg (categorical variable) (time frame: 30 days). The study lists 21 primary outcomes in all. 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 1 Jun 2023.