NCT06542393 PBM as Strategy to CABG Anemic Patients Bypass Graft (CABG)
| NCT ID | NCT06542393 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Federal University of São Paulo |
| Condition | Anemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2024-06-01 |
| Primary Completion | 2025-06-01 |
Trial Parameters
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
Brief Summary
Anemia poses risks during coronary artery bypass grafting (CABG), increasing complications and mortality rates. Blood transfusions in cardiac surgery have negative outcomes, prompting the use of erythropoietin in Patient Blood Management (PBM) to limit transfusion needs and enhance postoperative recovery. EPO can reduce blood component requirements, adverse events, and inflammation in anemic CABG patients. A study aims to minimize transfusions through a PBM anemia treatment protocol for CABG patients, comparing outcomes in three groups: a Control Group (CG), a Non-PBM Group (NPBMG) treated with blood components, and a PBM Group (GPBM) treated with EPO. Parameters include post-op stay, mortality, cardiovascular events, non-cardiovascular events, ICU time, mechanical ventilation duration, vasoactive drug use, inflammatory responses, and cardiac cell death. Analysis will consider demographic and clinical factors, with expectations that GPBM will yield superior results compared to NPBMG and similar or better outcomes than CG.
Eligibility 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%.