An interventional study of blood use for priming cardiopulmonary bypass circuit and clear prime for cardiopulmonary bypass in Congenital Heart Disease, sponsored by Augusta University. Recruiting at 1 site in United States. Per ClinicalTrials.gov, last updated 2023-06-01.
Sponsored by Augusta University · Not applicable, Interventional, and Supportive care
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.
3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.
This study's planned enrollment of 150 is above the median of 100 across 1,778 interventional studies indexed under Heart Diseases.
Browse Heart Diseases studies →Augusta University is the lead sponsor of 177 studies on the registry; 24 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 3 (30%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Other: blood use for priming cardiopulmonary bypass circuit
Other: clear prime for cardiopulmonary bypass
one arm will have the cardiopulmonary bypass circuit primed with blood
this arm will not have bypass circuit primed with blood
Age of patients undergoing bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
age in months
Time frame: 30 days
Weight of patients undergoing bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
weight in kg
Time frame: 30 days
Gender of patients undergoing bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
sex
Time frame: 30 days
Demographics of bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
race
Time frame: 30 days
Diagnosis of patients undergoing bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
preoperative diagnosis
Time frame: 30 days
Surgery performed in bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
surgery performed
Time frame: 30 days
Previous surgery prior to bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
any previous surgery
Time frame: 30 days
Blood received during bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
blood product received
Time frame: 30 days
Volume transfused during bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
volume of blood transfusion in mL
Time frame: 30 days
Number of patients with unplanned reoperation in bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
unplanned reoperation
Time frame: 30 days
Number of patients with unplanned cardiac catheterization in bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
unplanned cardiac catheterization
Time frame: 30 days
Number of patients with a neurologic complication in bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
neurologic complication
Time frame: 30 days
Number of patients with chylothorax in bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
chylothorax
Time frame: 30 days
Number of patients with vocal cord injury in bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
vocal cord injury
Time frame: 30 days
Number of patients with diaphragm paralysis in bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
diaphragm paralysis
Time frame: 30 days
Number of patients with pacemaker implantation in bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
pacemaker implantation
Time frame: 30 days
Number of patients with postoperative pneumothorax in bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
postoperative pneumothorax
Time frame: 30 days
Number of patients with wound infection in bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
wound infection
Time frame: 30 days
Number of patients with bleeding requiring reoperation in bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
bleeding requiring reoperation
Time frame: 30 days
Number of patients with pericardial effusion in bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
pericardial effusion
Time frame: 30 days
Number of patients who died following bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
mortality
Time frame: 30 days
Plan to share: No
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Augusta University