Using Erythropoietin to Reduce Blood Transfusions in Anemic Patients Undergoing Heart Surgery
Patient Blood Manegement (PBM) as Perioperative Strategy to Anemic Patients Who Will be Submitted to Coronary Artery Bypass Graft (CABG).
This study is testing if giving erythropoietin can help anemic patients undergoing heart surgery need fewer blood transfusions and recover better compared to those who don’t receive it.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Federal University of São Paulo Academic / other |
| Locations | 1 site (São Paulo, São Paulo) |
| Trial ID | NCT06542393 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of erythropoietin (EPO) as part of a Patient Blood Management (PBM) protocol to minimize blood transfusions in anemic patients undergoing coronary artery bypass grafting (CABG). It compares outcomes among three groups: a Control Group of non-anemic patients, a Non-PBM Group treated with blood components, and a PBM Group receiving EPO. The study aims to evaluate various postoperative parameters, including hospital stay, mortality, and cardiovascular events, to determine the effectiveness of EPO in improving recovery and reducing complications. The research is being conducted at Hospital São Paulo with a total of 120 participants.
Who should consider this trial
Good fit: Ideal candidates for this study are anemic patients scheduled for elective CABG surgery who meet specific inclusion criteria.
Not a fit: Patients with severe comorbidities or those requiring erythropoietin for other medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the need for blood transfusions and improve recovery outcomes for anemic patients undergoing CABG.
How similar studies have performed: Previous studies have shown promising results using erythropoietin in similar contexts, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Eletive surgery; * Only CABG as procedure; * Off pump CABG candidate. Exclusion Criteria: * Age \> 80 years; * Chronic dialytic kidney disease; * Chronic rheumatologic disease; * Men with Hb levels \> 13 g/dl and \< 8g/dl; * Women with Hb levels \> 12 g/dl and \< 8g/dl; * Presence of another heart disease requiring surgical intervention; * Presence of hepatic insufficiency; * Presence of any implantable electronic cardiac device in any cardiac chambers; * Pregnancy; * Diagnosis of malignant neoplasia; * Thrombophilias; * Need for Erythropoietin treatment due to any other disease. * Recent ischemic event (\< 3 months). * Ejection fraction \<30%.
Where this trial is running
São Paulo, São Paulo
- Leonardo Ohashi — São Paulo, São Paulo, Brazil (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.