Blood Conservation in Patients (3.5-12kg) Undergoing Congenital Cardiac Surgery

Study Overview
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Brief Summary
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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.

Official Title
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Differences in Outcomes for Patients (3.5-12kg) Undergoing Congenital Cardiac Surgery Who Receive Blood Versus Those Who do Not

Conditions
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Congenital Heart Disease

Intervention / Treatment
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* Other: blood use for priming cardiopulmonary bypass circuit
* Other: clear prime for cardiopulmonary bypass


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient weight 3.5-12kg Elective and urgent cardiac surgery with cardiopulmonary bypass Cases within the STS STAT categories of 1-4 Exclusion Criteria: 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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Blood prime for cardiopulmonary bypass<br> | Other: blood use for priming cardiopulmonary bypass circuit<br>* one arm will have the cardiopulmonary bypass circuit primed with blood<br>|
| Active Comparator: clear prime for cardiopulmonary bypass<br> | Other: clear prime for cardiopulmonary bypass<br>* this arm will not have bypass circuit primed with blood<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Age of patients undergoing bloodless cardiac surgery in patients 3.5-12kg (categorical variable) | age in months | 30 days | 
| Weight of patients undergoing bloodless cardiac surgery in patients 3.5-12kg (categorical variable) | weight in kg | 30 days | 
| Gender of patients undergoing bloodless cardiac surgery in patients 3.5-12kg (categorical variable) | sex | 30 days | 
| Demographics of bloodless cardiac surgery in patients 3.5-12kg (categorical variable) | race | 30 days | 
| Diagnosis of patients undergoing bloodless cardiac surgery in patients 3.5-12kg (categorical variable) | preoperative diagnosis | 30 days | 
| Surgery performed in bloodless cardiac surgery in patients 3.5-12kg (categorical variable) | surgery performed | 30 days | 
| Previous surgery prior to bloodless cardiac surgery in patients 3.5-12kg (categorical variable) | any previous surgery | 30 days | 
| Blood received during bloodless cardiac surgery in patients 3.5-12kg (categorical variable) | blood product received | 30 days | 
| Volume transfused during bloodless cardiac surgery in patients 3.5-12kg (categorical variable) | volume of blood transfusion in mL | 30 days | 
| Number of patients with unplanned reoperation in bloodless cardiac surgery in patients 3.5-12kg (categorical variable) | unplanned reoperation | 30 days | 
| Number of patients with unplanned cardiac catheterization in bloodless cardiac surgery in patients 3.5-12kg (categorical variable) | unplanned cardiac catheterization | 30 days | 
| Number of patients with a neurologic complication in bloodless cardiac surgery in patients 3.5-12kg (categorical variable) | neurologic complication | 30 days | 
| Number of patients with chylothorax in bloodless cardiac surgery in patients 3.5-12kg (categorical variable) | chylothorax | 30 days | 
| Number of patients with vocal cord injury in bloodless cardiac surgery in patients 3.5-12kg (categorical variable) | vocal cord injury | 30 days | 
| Number of patients with diaphragm paralysis in bloodless cardiac surgery in patients 3.5-12kg (categorical variable) | diaphragm paralysis | 30 days | 
| Number of patients with pacemaker implantation in bloodless cardiac surgery in patients 3.5-12kg (categorical variable) | pacemaker implantation | 30 days | 
| Number of patients with postoperative pneumothorax in bloodless cardiac surgery in patients 3.5-12kg (categorical variable) | postoperative pneumothorax | 30 days | 
| Number of patients with wound infection in bloodless cardiac surgery in patients 3.5-12kg (categorical variable) | wound infection | 30 days | 
| Number of patients with bleeding requiring reoperation in bloodless cardiac surgery in patients 3.5-12kg (categorical variable) | bleeding requiring reoperation | 30 days | 
| Number of patients with pericardial effusion in bloodless cardiac surgery in patients 3.5-12kg (categorical variable) | pericardial effusion | 30 days | 
| Number of patients who died following bloodless cardiac surgery in patients 3.5-12kg (categorical variable) | mortality | 30 days |