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

May 30, 2023 updated by: Augusta University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Augusta, Georgia, United States, 30912
        • Recruiting
        • Children's Hospital of Georgia
        • Contact:
        • Principal Investigator:
          • Brian Bateson, DO
        • Sub-Investigator:
          • James St. Louis, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Augusta University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 10, 2023

Primary Completion (Estimated)

May 11, 2025

Study Completion (Estimated)

May 12, 2026

Study Registration Dates

First Submitted

May 10, 2023

First Submitted That Met QC Criteria

May 19, 2023

First Posted (Actual)

May 31, 2023

Study Record Updates

Last Update Posted (Actual)

June 1, 2023

Last Update Submitted That Met QC Criteria

May 30, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2000190-3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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