Blood Conservation in Patients (3.5-12kg) Undergoing Congenital Cardiac Surgery
Differences in Outcomes for Patients (3.5-12kg) Undergoing Congenital Cardiac Surgery Who Receive Blood Versus Those Who do Not
1 other identifier
interventional
150
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 10, 2023
CompletedStudy Start
First participant enrolled
May 10, 2023
CompletedFirst Posted
Study publicly available on registry
May 31, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 11, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 12, 2026
CompletedJune 1, 2023
May 1, 2023
2 years
May 10, 2023
May 30, 2023
Conditions
Outcome Measures
Primary Outcomes (21)
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
Study Arms (2)
Blood prime for cardiopulmonary bypass
ACTIVE COMPARATORclear prime for cardiopulmonary bypass
ACTIVE COMPARATORInterventions
one arm will have the cardiopulmonary bypass circuit primed with blood
this arm will not have bypass circuit primed with blood
Eligibility Criteria
You may qualify if:
- Patient weight 3.5-12kg
- Elective and urgent cardiac surgery with cardiopulmonary bypass
- Cases within the STS STAT categories of 1-4
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Children's Hospital of Georgia
Augusta, Georgia, 30912, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 10, 2023
First Posted
May 31, 2023
Study Start
May 10, 2023
Primary Completion
May 11, 2025
Study Completion
May 12, 2026
Last Updated
June 1, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will not share