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

NCT06542393 | Recruiting Phase 2 DMC

• 1 other identifier: 0009/2023
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Mean number of units of Red Blood Cells (RBC)

  Compare the need of blood transfusion in the perioperative period

  Until perioperative day 3

Secondary Outcomes (13)

• Length of ICU stay

  From time of admission after surgery to time of clinical conditions of discharge (time of ICU medical discharge, not time of ICU room exit). Up to 240 hours.

• Length of hospital stay

  From time of ICU medical discharge until time of Hospital discharge (Up to 14 days).

• Length of mechanical ventilation

  From time of intubation by anesthesia team until time of extubation by ICU team (Up to 240 hours).

• Need of Dyalisis (Acute Kidney Disease)

  Based on KDIGO classification of Acute Kdney Injury, level III of the classification. (Up to 120 hours from ICU admission, accountable from the time Dyalisis is indicated).

• Perioperative infection

  Until perioperative day 3

Study Arms (3)

Randomized Anemia Group for non-PBM protocol (GNPBM)

EXPERIMENTAL

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)

Procedure: blood transfusion

Randomized Anemia Group for PBM protocol (GPBM)

EXPERIMENTAL

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)

Drug: Erythropoietin

Control Group (GC)

NO INTERVENTION

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)

Interventions

Erythropoietin 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.

Randomized Anemia Group for PBM protocol (GPBM)

blood transfusion 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 non-PBM protocol (GNPBM)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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%.

Sponsors & Collaborators

• Federal University of São Paulo: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

Leonardo Ohashi

São Paulo, São Paulo, 04024-002, Brazil

RECRUITING

Related Publications (42)

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MeSH Terms

Conditions

Anemia; Coronary Disease; Coronary Artery Disease; Coronary Stenosis; Coronary Occlusion; Hemorrhage

Interventions

Erythropoietin; Blood Transfusion

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Biological Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: Randomized (intervention group) for anemic patients Non-randomized (control group) for non-anemic patients

Study Record Dates

• First Submitted: July 9, 2024
• First Posted: August 7, 2024
• Study Start: June 1, 2024
• Primary Completion: June 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: August 7, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)