NCT05881564

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Augusta University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
OTHER	blood use for priming cardiopulmonary bypass circuit	one arm will have the cardiopulmonary bypass circuit primed with blood
OTHER	clear prime for cardiopulmonary bypass	this arm will not have bypass circuit primed with blood

Timeline

• Start date: 2023-05-10
• Primary completion: 2025-05-11
• Completion: 2026-05-12
• First posted: 2023-05-31
• Last updated: 2023-06-01

Locations

1 site across 1 country: United States