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

Augusta University

Status: Enrolling

Conditions: Congenital Heart Disease

Treatments: Other: blood use for priming cardiopulmonary bypass circuit; Other: clear prime for cardiopulmonary bypass

Study type: Interventional

Funder types: Other

Identifiers

NCT05881564

2000190-3

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Volunteers: No 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Blood prime for cardiopulmonary bypass

Active Comparator group

Treatment:

Other: blood use for priming cardiopulmonary bypass circuit

clear prime for cardiopulmonary bypass

Active Comparator group

Treatment:

Other: clear prime for cardiopulmonary bypass