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

NCT ID: NCT06542393

Last Updated: 2024-08-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-01
• Study Completion Date: 2026-06-01

Brief 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.

Detailed 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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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)

Group Type: EXPERIMENTAL

blood transfusion

Intervention Type: PROCEDURE

After surgery, this group will receive one unit of RBC at the moment of ICU admission.

Hb > 8 g/dl: 1 unit of RBC. HB < 8 g/dl: 2 units of RBC.

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)

Group Type: EXPERIMENTAL

Erythropoietin

Intervention Type: DRUG

• Treatment regimen for hospitalized patients awaiting non-urgent surgeries: Administer EPO 600 IU/kg/week via subcutaneous (SC) or intravenous (IV) route, followed by 300 IU/kg/day via SC or IV 10 days before surgery. If ferritin < 100 ng/dL, supplement with IV iron (Iron hydroxide up to 600 mg/week or Ferric carboxymaltose up to 1000 mg/week).
• Treatment regimen for hospitalized patients awaiting non-urgent surgeries with less than 5 days until surgery: Administer 40000 UI of EPO intravenous (IV) attack and supplement with IV iron (Iron hydroxide up to 600 mg/week or Ferric carboxymaltose up to 2000 mg/week), then 300UI/Kg/day IV or SC of EPO until day of surgery.

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)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Erythropoietin

• Treatment regimen for hospitalized patients awaiting non-urgent surgeries: Administer EPO 600 IU/kg/week via subcutaneous (SC) or intravenous (IV) route, followed by 300 IU/kg/day via SC or IV 10 days before surgery. If ferritin < 100 ng/dL, supplement with IV iron (Iron hydroxide up to 600 mg/week or Ferric carboxymaltose up to 1000 mg/week).
• Treatment regimen for hospitalized patients awaiting non-urgent surgeries with less than 5 days until surgery: Administer 40000 UI of EPO intravenous (IV) attack and supplement with IV iron (Iron hydroxide up to 600 mg/week or Ferric carboxymaltose up to 2000 mg/week), then 300UI/Kg/day IV or SC of EPO until day of surgery.

Intervention Type: DRUG

blood transfusion

After surgery, this group will receive one unit of RBC at the moment of ICU admission.

Hb > 8 g/dl: 1 unit of RBC. HB < 8 g/dl: 2 units of RBC.

Intervention Type: PROCEDURE

Eligibility Criteria

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%.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role: collaborator

Federal University of São Paulo

OTHER

Sponsor Role: lead

Responsible Party

LEONARDO OHASHI

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Leonardo Ohashi

São Paulo, São Paulo, Brazil

Site Status: RECRUITING

Countries

Brazil

Facility Contacts

ISABEL CESPEDES, PhD

Role: primary

isabel.cespedes@unifesp.br

05511996895763

LEONARDO OHASHI, MD

Role: backup

leonardo.ohashi@unifesp.br

05511970531919

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Other Identifiers

0009/2023

Identifier Type: -

Identifier Source: org_study_id