Using fresh autologous blood transfusion after heart surgery
Targeted Fresh Autologous Whole Blood Transfusion After Cardiopulmonary Bypass: a Prospective Randomized Controlled Trial.
This study tests if giving patients their own fresh blood after heart surgery can help them lose less blood and recover better compared to standard treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | University of Colorado, Denver Academic / other |
| Locations | 1 site (Aurora, Colorado) |
| Trial ID | NCT03204357 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of transfusing fresh autologous whole blood at the end of cardiopulmonary bypass during elective cardiac surgery. The study aims to reduce total blood loss 24 hours post-surgery and improve mitochondrial oxygen delivery, as indicated by plasma succinate levels. It is a prospective randomized interventional trial comparing fresh autologous blood transfusion to standard care for managing bleeding. The goal is to enhance patient outcomes by minimizing the need for stored blood products, which carry risks of complications.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 90 scheduled for elective cardiac surgery with cardiopulmonary bypass who can provide informed consent.
Not a fit: Patients who have received allogenic blood products in the past three months or have significant active infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce complications associated with blood transfusions and improve recovery outcomes for cardiac surgery patients.
How similar studies have performed: Previous studies have shown that autologous blood transfusion can effectively reduce blood loss and improve coagulation, but this specific approach targeting high-risk patients is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Adult subjects aged 18 to 90 2. Able to provide informed consent 3. Willing to accept autologous or allogenic blood transfusion 4. Scheduled for elective cardiac surgery with cardiopulmonary bypass Exclusion Criteria: 1. Pre-operative administration of allogenic blood bank products in the previous 3 months 2. Hemodynamically unstable defined as a systolic blood pressure less than 90 mmHg with a heart rate greater 100 or requiring intravenous vasopressor medications 3. Significant active infection or sepsis defined by positive blood culture or positive wound culture 4. Hemoglobin less than 7 g/dl
Where this trial is running
Aurora, Colorado
- University of Colorado Hospital — Aurora, Colorado, United States (Recruiting)
Study contacts
- Principal investigator: Nathan Clendenen, M.D. — University of Colorado - School of Medicine
- Study coordinator: Nathan J Clendenen, M.D.
- Email: nathan.clendenen@cuanschutz.edu
- Phone: 720-848-6709
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.