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

Primary Purpose

Congenital Heart Disease

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
blood use for priming cardiopulmonary bypass circuit
clear prime for cardiopulmonary bypass
Sponsored by
Augusta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Congenital Heart Disease

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Children's Hospital of GeorgiaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Blood prime for cardiopulmonary bypass

clear prime for cardiopulmonary bypass

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 10, 2023
Last Updated
May 30, 2023
Sponsor
Augusta University
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1. Study Identification

Unique Protocol Identification Number
NCT05881564
Brief Title
Blood Conservation in Patients (3.5-12kg) Undergoing Congenital Cardiac Surgery
Official Title
Differences in Outcomes for Patients (3.5-12kg) Undergoing Congenital Cardiac Surgery Who Receive Blood Versus Those Who do Not
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 10, 2023 (Actual)
Primary Completion Date
May 11, 2025 (Anticipated)
Study Completion Date
May 12, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Augusta University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Heart Disease

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Blood prime for cardiopulmonary bypass
Arm Type
Active Comparator
Arm Title
clear prime for cardiopulmonary bypass
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
blood use for priming cardiopulmonary bypass circuit
Intervention Description
one arm will have the cardiopulmonary bypass circuit primed with blood
Intervention Type
Other
Intervention Name(s)
clear prime for cardiopulmonary bypass
Intervention Description
this arm will not have bypass circuit primed with blood
Primary Outcome Measure Information:
Title
Age of patients undergoing bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
Description
age in months
Time Frame
30 days
Title
Weight of patients undergoing bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
Description
weight in kg
Time Frame
30 days
Title
Gender of patients undergoing bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
Description
sex
Time Frame
30 days
Title
Demographics of bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
Description
race
Time Frame
30 days
Title
Diagnosis of patients undergoing bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
Description
preoperative diagnosis
Time Frame
30 days
Title
Surgery performed in bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
Description
surgery performed
Time Frame
30 days
Title
Previous surgery prior to bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
Description
any previous surgery
Time Frame
30 days
Title
Blood received during bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
Description
blood product received
Time Frame
30 days
Title
Volume transfused during bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
Description
volume of blood transfusion in mL
Time Frame
30 days
Title
Number of patients with unplanned reoperation in bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
Description
unplanned reoperation
Time Frame
30 days
Title
Number of patients with unplanned cardiac catheterization in bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
Description
unplanned cardiac catheterization
Time Frame
30 days
Title
Number of patients with a neurologic complication in bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
Description
neurologic complication
Time Frame
30 days
Title
Number of patients with chylothorax in bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
Description
chylothorax
Time Frame
30 days
Title
Number of patients with vocal cord injury in bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
Description
vocal cord injury
Time Frame
30 days
Title
Number of patients with diaphragm paralysis in bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
Description
diaphragm paralysis
Time Frame
30 days
Title
Number of patients with pacemaker implantation in bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
Description
pacemaker implantation
Time Frame
30 days
Title
Number of patients with postoperative pneumothorax in bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
Description
postoperative pneumothorax
Time Frame
30 days
Title
Number of patients with wound infection in bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
Description
wound infection
Time Frame
30 days
Title
Number of patients with bleeding requiring reoperation in bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
Description
bleeding requiring reoperation
Time Frame
30 days
Title
Number of patients with pericardial effusion in bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
Description
pericardial effusion
Time Frame
30 days
Title
Number of patients who died following bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
Description
mortality
Time Frame
30 days

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Children's Hospital of Georgia
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lauren Allen
Phone
706-721-7608
Email
lauallen@augusta.edu
First Name & Middle Initial & Last Name & Degree
Brian Bateson, DO
First Name & Middle Initial & Last Name & Degree
James St. Louis, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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