Patient Blood Manegement (PBM) as Perioperative Strategy to Anemic Patients Who Will be Submitted to Coronary Artery Bypass Graft (CABG).

Status: Recruiting
Location: See location...
Intervention Type: Drug, Procedure
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: t
View:

• Eletive surgery;

• Only CABG as procedure;

• Off pump CABG candidate.

Locations
Other Locations
Brazil
Leonardo Ohashi
RECRUITING
São Paulo
Time Frame
Start Date: 2024-06-01
Estimated Completion Date: 2026-06-01
Participants
Target number of participants: 120
Treatments
Experimental: Randomized Anemia Group for non-PBM protocol (GNPBM)
Patients \> 18 years admitted to Hospital São Paulo for Coronary Artery Bypass Grafting (CABG) surgery who are hospitalized in the Cardiovascular Surgery department or another specialty unit and are anemic (Hemoglobin - Hb \< 12g/dl in women and \< 13g/dl in men)
Experimental: Randomized Anemia Group for PBM protocol (GPBM)
Patients \>18 years admitted to Hospital São Paulo for Coronary Artery Bypass Grafting (CABG) surgery who are hospitalized in the Cardiovascular Surgery department or another specialty unit and are anemic (Hb \< 12g/dl in women and \< 13g/dl in men)
No_intervention: Control Group (GC)
Patients \> 18 years admitted to Hospital SãoPaulo for Coronary Artery Bypass Grafting (CABG) surgery who arehospitalized in the Cardiovascular Surgery department or another specialty unit and do not have anemia (Hb \> 13g/dl in men and \> 12g/dl in women)
Sponsors
Collaborators: Fundação de Amparo à Pesquisa do Estado de São Paulo
Leads: Federal University of São Paulo

This content was sourced from clinicaltrials.gov

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