Using Patient Blood Management With Erythropoietin to Treat Anemia in Adults Undergoing Coronary Artery Bypass Graft Surgery
Led by Federal University of São Paulo · Updated on 2024-08-07
120
Participants Needed
1
Research Sites
52 weeks
Total Duration
AI-Summary
What this Trial Is About
Anemia increases risks during coronary artery bypass grafting CABG, leading to more complications and higher mortality. Blood transfusions during cardiac surgery can cause negative outcomes, so erythropoietin EPO is studied as part of Patient Blood Management PBM to reduce transfusion needs and improve recovery. This Phase 2 study compares three groups non-anemic controls, anemic patients treated with blood transfusions, and anemic patients treated with EPO, to assess various clinical and inflammatory outcomes.
Participants are assigned to one of three groups a Control Group of non-anemic patients, a Non-PBM Group receiving blood transfusions as needed, and a PBM Group treated with EPO before surgery. EPO is given via subcutaneous or intravenous routes with specific dosing schedules depending on time before surgery and iron supplementation if needed. The Non-PBM group receives red blood cell transfusions after surgery based on hemoglobin levels. The study focuses on reducing or eliminating transfusions in the perioperative period.
During the study, researchers will measure the average number of red blood cell units given until three days after surgery, length of ICU and hospital stays, mechanical ventilation time, need for dialysis, bleeding, infections, inflammatory and epigenetic changes, cardiac events like stroke and myocardial infarction, hemoglobin levels, and mortality. The study also considers demographic and clinical factors. Participants are followed from surgery until hospital discharge to evaluate these outcomes.
CONDITIONS
Brief Title
PBM as Strategy to CABG Anemic Patients Bypass Graft (CABG)
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Fundação de Amparo à Pesquisa do Estado de São Paulo
Collaborating Sponsor
Who Can Participate
Age: 18Years - 80Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
Scheduled for elective surgery
Only undergoing coronary artery bypass grafting (CABG)
Candidate for off-pump CABG
Aged between 18 and 80 years
You will not qualify if you...
Age over 80 years
Chronic dialytic kidney disease
Chronic rheumatologic disease
Men with hemoglobin levels above 13 g/dl or below 8 g/dl
Women with hemoglobin levels above 12 g/dl or below 8 g/dl
Presence of other heart diseases requiring surgery
Hepatic insufficiency
Presence of any implantable electronic cardiac device
Pregnancy
Diagnosis of malignant neoplasia
Thrombophilias
Need for erythropoietin treatment due to other diseases
Recent ischemic event within the last 3 months
Ejection fraction below 30%
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 10 days before surgery and perioperative period
Participants receive erythropoietin and iron supplementation as part of Patient Blood Management prior to surgery and undergo coronary artery bypass graft (CABG) surgery. Some participants receive blood transfusions after surgery as needed.
Multiple visits during preoperative treatment and hospital stay for surgery and postoperative care
Follow-up
Duration - Up to 14 days after surgery
Participants are monitored postoperatively for up to 14 days to assess outcomes such as length of ICU and hospital stay, need for mechanical ventilation, infections, bleeding, and mortality.
Daily monitoring visits during hospital stay
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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