Clinical Trial

PBM as Strategy to CABG Anemic Patients Bypass Graft (CABG)

Recruiting Phase 2
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Record status
This record was last updated August 7, 2024 (before its estimated June 1, 2025 completion). Its status may not reflect the trial's current state.
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.
Trial Details
NCT Number NCT06542393
Lead Sponsor Federal University of São Paulo
Collaborators: Fundação de Amparo à Pesquisa do Estado de São Paulo
Conditions Anemia, Coronary Disease, Coronary Artery Disease, Coronary Stenosis, Coronary Occlusion, Systemic Inflammatory Response, Bleeding, Epigenetic Disorder
Enrollment 120 participants
Start Date 2024-06-01
Primary Completion 2025-06-01 (estimated)
Study Completion 2026-06-01 (estimated)
Updated on ClinicalTrials.gov 2024-08-07