PBM as Strategy to CABG Anemic Patients Bypass Graft (CABG)
NCT Number: NCT06542393
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Anemia|Coronary Disease|Coronary Artery Disease|Coronary Stenosis|Coronary Occlusion|Systemic Inflammatory Response|Bleeding|Epigenetic Disorder
Interventions: DRUG: Erythropoietin|PROCEDURE: blood transfusion
Sponsor: Federal University of São Paulo
Collaborators: Fundação de Amparo à Pesquisa do Estado de São Paulo
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, CARE_PROVIDER)|Primary Purpose: TREATMENT
Start Date: 2024-06-01
Completion Date: 2026-06-01
Locations: Leonardo Ohashi, São Paulo, SAO Paulo, 04024-002, Brazil

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.

Primary Outcome Measures: Mean number of units of Red Blood Cells (RBC), Compare the need of blood transfusion in the perioperative period, Until perioperative day 3
Secondary Outcome Measures: Length of ICU stay, Hours, From time of admission after surgery to time of clinical conditions of discharge (time of ICU medical discharge, not time of ICU room exit). Up to 240 hours.|Length of hospital stay, Days, From time of ICU medical discharge until time of Hospital discharge (Up to 14 days).|Length of mechanical ventilation, Hours, From time of intubation by anesthesia team until time of extubation by ICU team (Up to 240 hours).|Need of Dyalisis (Acute Kidney Disease), Needing of dyalisis in peoperative period, Based on KDIGO classification of Acute Kdney Injury, level III of the classification. (Up to 120 hours from ICU admission, accountable from the time Dyalisis is indicated).|Perioperative infection, Anytype, Until perioperative day 3|Bleeding, Thorax drain tubes bleeding (ml), From time of admission on ICU until hour 24th after admission (accountable amount from how many chest tubes the patient was admitted).|Epigenetics alterations, . Differentially methylated regions (DMRs) and differentially methylated loci (DMLs) will be considered to determine if these regions are hypermethylated or hypomethylated in the comparison between groups., Until perioperative day 3|Inflammatory response, A total of 25 μl of serum per patient will be used for the detection of the following analytes: IL-1β, IL-6, IL-10, TNF-α, CRP, and NT-ProBNP., Until perioperative day 3|Perioperative myocardial infarction, According to type 5 Myocardial ischemia, Until perioperative day 3|Stroke, Any level of neurological deficit, Until perioperative day 3|Hemoglobin levels, Accountable in g/dl, Until perioperative day 3 and at discharge|All-cause mortality, Death from any cause accountable as in-hospital mortality, From day of the intervention (if intervention group) or from the moment of surgery (if control group) until day of hospital discharge (death from any cause accountable as in-hospital mortality).|Cardiovascular mortality, any cardiovascular reason as main cause of death accountable as in-hospital mortality, From day of the intervention (if intervention group) or from the moment of surgery (if control group) until day of hospital discharge (any cardiovascular reason as main cause of death accountable as in-hospital mortality).)