MedTrace Logo

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

NCT05881564 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2023-06-01

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Augusta University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-10
Primary Completion
2025-05-11
Completion
2026-05-12

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05881564 on ClinicalTrials.gov