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

Not Applicable

Recruiting

• Conditions: Congenital Heart Disease
• Interventions: Other: clear prime for cardiopulmonary bypass; Other: blood use for priming cardiopulmonary bypass circuit

• Registration Number: NCT05881564
• Lead Sponsor: Augusta University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-05
• Study Start: 2023-05-10
• Study First Submitted: 2023-05-10
• Study First Submitted QC: 2023-05-19
• Last Update Submitted: 2023-05-30
• Study First Posted: 2023-05-31
• Last Update Posted: 2023-06-01
• Primary Completion: 2025-05-11
• Study Completion: 2026-05-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
clear prime for cardiopulmonary bypass	clear prime for cardiopulmonary bypass	-
Blood prime for cardiopulmonary bypass	blood use for priming cardiopulmonary bypass circuit	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

Children's Hospital of Georgia; 🇺🇸 Augusta, Georgia, United States