Evaluating blood conservation in young patients undergoing heart surgery
Differences in Outcomes for Patients (3.5-12kg) Undergoing Congenital Cardiac Surgery Who Receive Blood Versus Those Who do Not
NA · Augusta University · NCT05881564
This study is testing whether young children undergoing heart surgery can recover better and have fewer complications if they don't receive blood products during the procedure.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Sex | All |
| Sponsor | Augusta University (other) |
| Locations | 1 site (Augusta, Georgia) |
| Trial ID | NCT05881564 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the clinical outcomes of patients weighing between 3.5 and 12 kg who undergo congenital cardiac surgery with cardiopulmonary bypass, comparing those who receive blood products to those who do not. The primary hypothesis is that patients who have bloodless surgery will experience lower morbidity and mortality rates, as well as shorter stays in the ICU and hospital. The study will involve elective and urgent surgeries categorized within the STS STAT categories of 1-4, focusing on the impact of blood conservation techniques.
Who should consider this trial
Good fit: Ideal candidates are patients aged 3.5 to 12 kg scheduled for elective or urgent congenital cardiac surgery requiring cardiopulmonary bypass.
Not a fit: Patients who are outside the weight range, undergoing emergency surgeries, or have specific medical conditions such as blood dyscrasias will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved recovery outcomes and reduced complications for young patients undergoing cardiac surgery.
How similar studies have performed: While the specific approach of bloodless cardiac surgery in this weight range may be novel, similar studies have shown promising outcomes in reducing complications associated with blood transfusions.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Augusta, Georgia
- Children's Hospital of Georgia — Augusta, Georgia, United States (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Congenital Heart Disease