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

Federal University of São Paulo

Status and phase: Enrolling; Phase 2

Conditions: Anemia; Coronary Artery Disease; Epigenetic Disorder; Systemic Inflammatory Response; Coronary Disease; Coronary Occlusion; Coronary Stenosis; Bleeding

Treatments: Procedure: blood transfusion; Drug: Erythropoietin

Study type: Interventional

Funder types: Other

Identifiers

NCT06542393

0009/2023

Details and patient eligibility

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.

Full description

Anemia increases the risk of postoperative complications and mortality in patients undergoing coronary artery bypass grafting (CABG). In addition, the use of blood transfusions during cardiac surgery is associated with adverse effects and unfavorable outcomes. To reduce the need for transfusions and improve post-operative results, erythropoietin is used as part of Patient Blood Management (PBM). In anemic patients undergoing CABG, the use of Erythropoietin (EPO) can eliminate the need for blood components during and after surgery, as well as reduce adverse events and inflammation. The objectives of the proposed study are to reduce or eliminate the number of transfusions in the intraoperative and postoperative context by means of a Patient Blood Management (PBM) anemia treatment protocol for anemic patients who will undergo Coronary Artery Bypass Graft Surgery (CABG). The proposed study is a prospective, non-controlled interventional study to be carried out with anemic patients awaiting CABG surgery at Hospital São Paulo. There will be three groups of 40 participants each: Control Group (CG) of non-anemic individuals preoperatively; Non- PBM Group (NPBMG) of anemic individuals preoperatively and treated with blood components according to need; PBM Group (GPBM) of anemic individuals preoperatively and treated with EPO. The following parameters will be compared: length of postoperative hospital stay; mortality; postoperative cardiovascular events: clinical stroke, perioperative infarction, surgical reoperation due to bleeding; non- cardiovascular events: surgical site-associated infection and acute renal dysfunction; time in postoperative intensive care; time on mechanical ventilation; need for vasoactive drug use; inflammatory process and intra- and postoperative cardiac cell death. Confounding factors such as demographic and clinical parameters will be included in the analysis. It is expected that the GPBM will obtain the best results in relation to the GNPBM, similar to or better than the CG.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Eletive surgery;
• Only CABG as procedure;
• Off pump CABG candidate.

Exclusion criteria

• Age > 80 years;
• Chronic dialytic kidney disease;
• Chronic rheumatologic disease;
• Men with Hb levels > 13 g/dl and < 8g/dl;
• Women with Hb levels > 12 g/dl and < 8g/dl;
• Presence of another heart disease requiring surgical intervention;
• Presence of hepatic insufficiency;
• Presence of any implantable electronic cardiac device in any cardiac chambers;
• Pregnancy;
• Diagnosis of malignant neoplasia;
• Thrombophilias;
• Need for Erythropoietin treatment due to any other disease.
• Recent ischemic event (< 3 months).
• Ejection fraction <30%.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 3 patient groups

Randomized Anemia Group for non-PBM protocol (GNPBM)

Experimental group

Description:

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)

Treatment:

Procedure: blood transfusion

Randomized Anemia Group for PBM protocol (GPBM)

Experimental group

Description:

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)

Treatment:

Drug: Erythropoietin

Control Group (GC)

No Intervention group

Description:

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)