Recruiting

Observational Study

Sponsor:

Augusta University

Code:

NCT05881564

Conditions

Congenital Heart Disease

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

blood use for priming cardiopulmonary bypass circuit

clear prime for cardiopulmonary bypass

Study Details

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.

Conditions

Congenital Heart Disease

Study ID

NCT05881564

Start date

May 10, 2023

Status verified date

May, 2023

Completion date

May 12, 2026

Anticipated

Primary completion date

May 11, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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 Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

active comparator: Blood prime for cardiopulmonary bypass

active comparator: clear prime for cardiopulmonary bypass

Interventions

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

Primary outcome measure

  • Age of patients undergoing bloodless cardiac surgery in patients 3.5-12kg (categorical variable) [ Time Frame: 30 days ]
  • Weight of patients undergoing bloodless cardiac surgery in patients 3.5-12kg (categorical variable) [ Time Frame: 30 days ]
  • Gender of patients undergoing bloodless cardiac surgery in patients 3.5-12kg (categorical variable) [ Time Frame: 30 days ]
  • Demographics of bloodless cardiac surgery in patients 3.5-12kg (categorical variable) [ Time Frame: 30 days ]
  • Diagnosis of patients undergoing bloodless cardiac surgery in patients 3.5-12kg (categorical variable) [ Time Frame: 30 days ]
  • Surgery performed in bloodless cardiac surgery in patients 3.5-12kg (categorical variable) [ Time Frame: 30 days ]
  • Previous surgery prior to bloodless cardiac surgery in patients 3.5-12kg (categorical variable) [ Time Frame: 30 days ]
  • Blood received during bloodless cardiac surgery in patients 3.5-12kg (categorical variable) [ Time Frame: 30 days ]
  • Volume transfused during bloodless cardiac surgery in patients 3.5-12kg (categorical variable) [ Time Frame: 30 days ]
  • Number of patients with unplanned reoperation in bloodless cardiac surgery in patients 3.5-12kg (categorical variable) [ Time Frame: 30 days ]
  • Number of patients with unplanned cardiac catheterization in bloodless cardiac surgery in patients 3.5-12kg (categorical variable) [ Time Frame: 30 days ]
  • Number of patients with a neurologic complication in bloodless cardiac surgery in patients 3.5-12kg (categorical variable) [ Time Frame: 30 days ]
  • Number of patients with chylothorax in bloodless cardiac surgery in patients 3.5-12kg (categorical variable) [ Time Frame: 30 days ]
  • Number of patients with vocal cord injury in bloodless cardiac surgery in patients 3.5-12kg (categorical variable) [ Time Frame: 30 days ]
  • Number of patients with diaphragm paralysis in bloodless cardiac surgery in patients 3.5-12kg (categorical variable) [ Time Frame: 30 days ]
  • Number of patients with pacemaker implantation in bloodless cardiac surgery in patients 3.5-12kg (categorical variable) [ Time Frame: 30 days ]
  • Number of patients with postoperative pneumothorax in bloodless cardiac surgery in patients 3.5-12kg (categorical variable) [ Time Frame: 30 days ]
  • Number of patients with wound infection in bloodless cardiac surgery in patients 3.5-12kg (categorical variable) [ Time Frame: 30 days ]
  • Number of patients with bleeding requiring reoperation in bloodless cardiac surgery in patients 3.5-12kg (categorical variable) [ Time Frame: 30 days ]
  • Number of patients with pericardial effusion in bloodless cardiac surgery in patients 3.5-12kg (categorical variable) [ Time Frame: 30 days ]
  • Number of patients who died following bloodless cardiac surgery in patients 3.5-12kg (categorical variable) [ Time Frame: 30 days ]

Central Contacts and Locations

Locations

Children's Hospital of Georgia

Recruiting

Augusta, Georgia, United States, 30912

Contacts

Lauren Allen

706-721-7608lauallen@augusta.edu

Principal Investigator:

Brian Bateson, DO

More Information

Sponsor

Augusta University

Last update posted

Jun 1, 2023

Last verified

May, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Augusta University on 2023-06-01.