Actively Recruiting
PBM as Strategy to CABG Anemic Patients Bypass Graft (CABG)
Led by Federal University of São Paulo · Updated on 2024-08-07
120
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
F
Federal University of São Paulo
Lead Sponsor
F
Fundação de Amparo à Pesquisa do Estado de São Paulo
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
PBM as Strategy to CABG Anemic Patients Bypass Graft (CABG)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Scheduled for elective surgery
- Undergoing only coronary artery bypass graft (CABG) procedure
- Candidate for off-pump CABG
You will not qualify if you...
- Age over 80 years
- Chronic dialysis-dependent kidney disease
- Chronic rheumatologic disease
- Men with hemoglobin levels greater than 13 g/dl or less than 8 g/dl
- Women with hemoglobin levels greater than 12 g/dl or less than 8 g/dl
- Presence of another heart disease requiring surgical intervention
- Hepatic insufficiency
- Any implantable electronic cardiac device in heart chambers
- Pregnancy
- Diagnosis of malignant neoplasia
- Thrombophilias
- Need for erythropoietin treatment due to other diseases
- Recent ischemic event within 3 months
- Ejection fraction less than 30%
AI-Screening
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Trial Site Locations
Total: 1 location
1
Leonardo Ohashi
São Paulo, São Paulo, Brazil, 04024-002
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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