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

Congenital Heart Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05881564
• Other study ID #: 2000190-3
• Status: Recruiting
• Phase: N/A
• Start date: May 10, 2023
• Est. completion date: May 12, 2026

Study information

• Verified date: May 2023
• Source: Augusta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: May 12, 2026
• Est. primary completion date: May 11, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases

Intervention

Other:
• blood use for priming cardiopulmonary bypass circuit
one arm will have the cardiopulmonary bypass circuit primed with blood
• clear prime for cardiopulmonary bypass
this arm will not have bypass circuit primed with blood

Locations

Country	Name	City	State
United States	Children's Hospital of Georgia	Augusta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Augusta University

Country where clinical trial is conducted

United States, 

Outcome

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